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Investigating a Vaccine Against COVID-19

Primary Purpose

Coronavirus

Status
Active
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
ChAdOx1 nCoV-19 (Abs 260)
MenACWY vaccine
ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
Two dose MenACWY vaccine
ChAdOx1 nCoV-19 (qPCR)
ChAdOx1 nCoV-19 0.5mL prime plus boost
Two dose MenACWY vaccine min. 4 weeks apart
Two dose ChAdOx1 nCoV-19/Covishield 0.5mL
Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronavirus focused on measuring Covid-19, ChAdOx1 nCov19, sars-cov-2, vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults aged 18 - 55 years (groups 4, 5, 6 and 11)
  • Adults aged 56-69 years (groups 1, 7, and 9)
  • Adults aged 70 years and older (groups 2, 8, and 10)
  • Able and willing (in the Investigator's opinion) to comply with all study requirements.
  • Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.
  • For females of childbearing potential only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination.
  • Agreement to refrain from blood donation during the course of the study.
  • Provide written informed consent.

Additional Inclusion criteria to Group 12 (HIV sub-study):

  • HIV positive
  • Receiving antiretroviral therapy
  • Undetectable HIV viral load
  • CD4>350 cells/mL

Exclusion Criteria:

• Participation in COVID-19 prophylactic drug trials for the duration of the study.

Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The COV002 study team should be informed as soon as possible.

• Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.

Note: Disclosure of serostatus post enrolment may accidently unblind participants to group allocation. Participation in COV002 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys

  • Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination, with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccination. Participants will be encouraged to receive these vaccinations at least 7 days before or after their study vaccine.
  • Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). This exclusion criteria will not apply to group 11, as recruitment will be targeted at those volunteers who previously received a ChAdOx1 vectored vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
  • Any confirmed or suspected immunosuppressive or immunodeficient state (except group 12, where HIV infected participants are allowed); asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days)
  • History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY
  • Any history of angioedema.
  • Any history of anaphylaxis.
  • Pregnancy, lactation or willingness/intention to become pregnant during the study.
  • Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
  • History of serious psychiatric condition likely to affect participation in the study.
  • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
  • Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
  • Suspected or known current alcohol or drug dependency.
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
  • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
  • History of laboratory confirmed COVID-19 (except groups 5d, 5e, 5f, 9, 10 and 11).
  • Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 5e, 5f, 9, 10 and 11)
  • NB: volunteers with previous NAAT positive results are also allowed in groups 9, 10 and 11

Additional Exclusion criteria to Groups 4, 6, 9 and 10

  • History of allergic disease or reactions likely to be exacerbated by Paracetamol
  • Note: Caution should be taken when recommending paracetamol to adults who already take paracetamol chronically

Re-vaccination exclusion criteria (two-dose groups only)

  • Anaphylactic reaction following administration of vaccine
  • Pregnancy. An exception to this will be prior to receipt of a booster dose at extra visit B. If a pregnant woman has discussed vaccination with their usual clinician (e.g. GP) and chooses to receive a COVID-19 vaccination, this may be administered by the trial team as part of extra visit B. (Protocol 19.0) or as part of the provision of treatment to controls.
  • Any AE that in the opinion of the Investigator may affect the safety of the participant or the interpretation of the study results

Sites / Locations

  • University Hospital Southampton NHS Foundation Trust
  • Castle Hill Hospital
  • St Georges University Hospital NHS Foundation Trust
  • University Hospitals Birmingham NHS Foundation Trust
  • University Hospitals Bristol and Weston NHS Foundation Trust
  • North Bristol NHS Trust
  • NIHR Cambridge Clinical Research Facility
  • NHS Lothian, Western General Hospital
  • Glasgow University and NHS Greater Glasgow & Clyde, New Lister Building, Glasgow Royal Infirmary & Queen Elizabeth University Hospital
  • Liverpool School of Tropical Medicine (LSTM), Accelerator Research Clinic. Clinical Sciences Accelerator
  • London North West University Healthcare Trust (LNWUH), Northwick Park Hospital
  • University College London Hospitals NHS Foundation Trust
  • Guy's and St Thomas' NHS Foundation Trust, Department of Infection, St Thomas Hospital
  • Imperial College Healthcare NHS Trust
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary
  • Public Health Wales
  • University of Nottingham Health Service, Cripps Health Centre, University Park
  • CCVTM, University of Oxford, Churchill Hospital
  • John Radcliffe Hospital
  • Sheffield Teaching Hospitals, Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Arm 26

Arm 27

Arm 28

Arm 29

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1 a1

Group 1 a3

Group 1 b1

Group 2 a1

Group 2 a3

Group 2 b1

Group 4 a1

Group 4 b1

Group 4 c1

Group 5 a1

Group 5 a3

Group 5 b1

Group 5 c1

Group 5 d1

Group 5 e1

Group 5 f1

Group 6 a1

Group 6 b1

Group 7 a1

Group 7 b1

Group 8 a1

Group 8 b1

Group 9 a1

Group 10 a1

Group 11

Group 12

Single dose MenACWY

Two dose MenACWY 4 - 6 weeks

Two dose MenACWY minimum 4 weeks

Arm Description

Volunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260)

Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks from prime

Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost (4-6 weeks apart)

Volunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260)

Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks apart

.Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost 4-6 weeks apart

Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp (Abs 260)

Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost 4-6 weeks apart

Volunteers will receive two doses of ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs260) prime and 2.2x10^10vp (qPCR) boost*, at least 4 weeks apart

Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp, (Abs 260)

Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks from prime

Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x1010vp, (qPCR)

Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp, (qPCR)

Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart

Two dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10^11 vp/mL), 4-6 weeks apart

Two dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart

Volunteers will receive a single dose ofChAdOx1 nCoV19 vaccine, 5x1010vp (qPCR)

Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 5x1010vp (Abs260) prime and 0.5mL (3.5 - 6.5 × 1010 vp, Abs 260)* boost* at least 4 weeks apart

Volunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)

Volunteers will receive two doses of ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)* 4-6 weeks apart

Volunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)

Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart

Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart

Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart

Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart

Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart

Groups 1 a2, 2 a2, 4 a2, 5 a2, 5 b2, 5 c2, 6 a2, 7 a2 & 8 a2 will receive a standard single dose of MenACWY vaccine

Groups 1 b2, 2 b2, 4 b2, 5 d2, 7 b2, 8 b2, 9 a2 & 10 a2 will receive two doses of MenACWY 4-6 weeks apart

Groups 1 a4, 2 a4, 4 c2, 5 a4, 6b2 will receive two doses of MenACWY at least 4 weeks apart

Outcomes

Primary Outcome Measures

Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.
Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19
Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults
Occurrence of serious adverse events (SAEs) throughout the study duration.

Secondary Outcome Measures

Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited local reactogenicity signs and symptoms for 7 days following
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 through standard blood tests (full blood count, liver and kidney function tests)
Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results; except groups 4, 6, 9 & 10)
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes
Occurrence of disease enhancement episodes
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions
Number of hospital admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19
Number of intensive care unit (ICU) admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: number of deaths
Number of deaths associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates
Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring incidence of Covid-19
Proportion of people diagnosed with severe Covid-19 disease (defined according to clinical severity scales)
Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification
Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion
Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 7 and 8 only)
Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only): local reactogenicity
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only): systemic reactogenicity
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following booster vaccination
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only)
Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) through standard blood tests (full blood count, liver and kidney function tests)
Frequency of participants with clinically significant changes from baseline from pre-booster for safety laboratory measures (haematology and biochemistry blood results)
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) via seroconversion
Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only)
Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination

Full Information

First Posted
May 12, 2020
Last Updated
July 31, 2023
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT04400838
Brief Title
Investigating a Vaccine Against COVID-19
Official Title
A Phase 2/3 Study to Determine the Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers.
Detailed Description
There will be 12 study groups and it is anticipated that a total of 12,390 volunteers will be enrolled. Groups 1, 7 & 9 are adults aged 56-69 years; groups 2, 8 & 10 are adults 70 years and over; groups 4, 5 & 6 are adults aged 18-55 years; group 11 is adults aged 18-55 years who have previously received a ChAdOx vectored vaccine; group 12 is HIV positive adults aged 18-55 years. The vaccine will be administered intramuscularly into the deltoid of the non-dominant arm (preferably). All subjects will undergo follow-up for a total of 1 year post last vaccination. Additional visits or procedures may be performed at the discretion of the investigators, e.g., further medical history and physical examination, or additional blood tests and other investigations if clinically relevant

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus
Keywords
Covid-19, ChAdOx1 nCov19, sars-cov-2, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 a1
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260)
Arm Title
Group 1 a3
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks from prime
Arm Title
Group 1 b1
Arm Type
Experimental
Arm Description
Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost (4-6 weeks apart)
Arm Title
Group 2 a1
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260)
Arm Title
Group 2 a3
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks apart
Arm Title
Group 2 b1
Arm Type
Experimental
Arm Description
.Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost 4-6 weeks apart
Arm Title
Group 4 a1
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp (Abs 260)
Arm Title
Group 4 b1
Arm Type
Experimental
Arm Description
Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost 4-6 weeks apart
Arm Title
Group 4 c1
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs260) prime and 2.2x10^10vp (qPCR) boost*, at least 4 weeks apart
Arm Title
Group 5 a1
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp, (Abs 260)
Arm Title
Group 5 a3
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks from prime
Arm Title
Group 5 b1
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x1010vp, (qPCR)
Arm Title
Group 5 c1
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp, (qPCR)
Arm Title
Group 5 d1
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Arm Title
Group 5 e1
Arm Type
Experimental
Arm Description
Two dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10^11 vp/mL), 4-6 weeks apart
Arm Title
Group 5 f1
Arm Type
Experimental
Arm Description
Two dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart
Arm Title
Group 6 a1
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose ofChAdOx1 nCoV19 vaccine, 5x1010vp (qPCR)
Arm Title
Group 6 b1
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 5x1010vp (Abs260) prime and 0.5mL (3.5 - 6.5 × 1010 vp, Abs 260)* boost* at least 4 weeks apart
Arm Title
Group 7 a1
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)
Arm Title
Group 7 b1
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)* 4-6 weeks apart
Arm Title
Group 8 a1
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)
Arm Title
Group 8 b1
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Arm Title
Group 9 a1
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Arm Title
Group 10 a1
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Arm Title
Group 11
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Arm Title
Group 12
Arm Type
Experimental
Arm Description
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Arm Title
Single dose MenACWY
Arm Type
Active Comparator
Arm Description
Groups 1 a2, 2 a2, 4 a2, 5 a2, 5 b2, 5 c2, 6 a2, 7 a2 & 8 a2 will receive a standard single dose of MenACWY vaccine
Arm Title
Two dose MenACWY 4 - 6 weeks
Arm Type
Active Comparator
Arm Description
Groups 1 b2, 2 b2, 4 b2, 5 d2, 7 b2, 8 b2, 9 a2 & 10 a2 will receive two doses of MenACWY 4-6 weeks apart
Arm Title
Two dose MenACWY minimum 4 weeks
Arm Type
Active Comparator
Arm Description
Groups 1 a4, 2 a4, 4 c2, 5 a4, 6b2 will receive two doses of MenACWY at least 4 weeks apart
Intervention Type
Biological
Intervention Name(s)
ChAdOx1 nCoV-19 (Abs 260)
Intervention Description
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Intervention Type
Biological
Intervention Name(s)
MenACWY vaccine
Other Intervention Name(s)
Menveo, Nimenrix
Intervention Description
Standard single dose of MenACWY vaccine
Intervention Type
Biological
Intervention Name(s)
ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
Intervention Description
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260 and 2.2x10^10vp ChAdOx1 nCoV-19 boost measured by qPCR 4-6 weeks later
Intervention Type
Biological
Intervention Name(s)
Two dose MenACWY vaccine
Other Intervention Name(s)
Menveo, Nimenrix
Intervention Description
Two standard doses of MenACWY vaccine 4-6 weeks apart
Intervention Type
Biological
Intervention Name(s)
ChAdOx1 nCoV-19 (qPCR)
Intervention Description
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Intervention Type
Biological
Intervention Name(s)
ChAdOx1 nCoV-19 0.5mL prime plus boost
Intervention Description
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)
Intervention Type
Biological
Intervention Name(s)
Two dose MenACWY vaccine min. 4 weeks apart
Other Intervention Name(s)
Menveo, Nimenrix
Intervention Description
Two standard doses of MenACWY vaccine minimum 4 weeks apart
Intervention Type
Biological
Intervention Name(s)
Two dose ChAdOx1 nCoV-19/Covishield 0.5mL
Intervention Description
Two dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10^11 vp/mL), 4-6 weeks apart
Intervention Type
Biological
Intervention Name(s)
Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL
Intervention Description
Two dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart
Primary Outcome Measure Information:
Title
Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.
Description
Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19
Time Frame
Study duration (12 months from last vaccination)
Title
Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults
Description
Occurrence of serious adverse events (SAEs) throughout the study duration.
Time Frame
Study duration (12 months from last vaccination)
Secondary Outcome Measure Information:
Title
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited local reactogenicity signs and symptoms for 7 days following
Description
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Time Frame
7 days post vaccination
Title
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following
Description
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Time Frame
7 days post vaccination
Title
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Description
Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Time Frame
28 days post vaccination
Title
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 through standard blood tests (full blood count, liver and kidney function tests)
Description
Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results; except groups 4, 6, 9 & 10)
Time Frame
6 months
Title
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes
Description
Occurrence of disease enhancement episodes
Time Frame
Study duration (12 months from last vaccination)
Title
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions
Description
Number of hospital admissions associated with COVID-19
Time Frame
Study duration (12 months from last vaccination)
Title
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19
Description
Number of intensive care unit (ICU) admissions associated with COVID-19
Time Frame
6 months
Title
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: number of deaths
Description
Number of deaths associated with COVID-19
Time Frame
6 months
Title
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates
Description
Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Time Frame
6 months
Title
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring incidence of Covid-19
Description
Proportion of people diagnosed with severe Covid-19 disease (defined according to clinical severity scales)
Time Frame
Study duration (12 months from last vaccination)
Title
Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification
Description
Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Time Frame
28 days post vaccination
Title
Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion
Description
Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination
Time Frame
28 days post vaccination
Title
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 7 and 8 only)
Description
Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Time Frame
6 months
Title
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only): local reactogenicity
Description
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination
Time Frame
7 days post vaccination
Title
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only): systemic reactogenicity
Description
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following booster vaccination
Time Frame
7 days post vaccination
Title
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only)
Description
Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination
Time Frame
28 days post vaccination
Title
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) through standard blood tests (full blood count, liver and kidney function tests)
Description
Frequency of participants with clinically significant changes from baseline from pre-booster for safety laboratory measures (haematology and biochemistry blood results)
Time Frame
6 months
Title
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) via seroconversion
Description
Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)
Time Frame
56 days post vaccination
Title
Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only)
Description
Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination
Time Frame
56 days post vaccination
Other Pre-specified Outcome Measures:
Title
Exploratory Immunology by virus neutralising antibody assays
Description
Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus
Time Frame
6 months
Title
Exploratory Immunology by flow cytometry
Description
Cell analysis by flow cytometry assays
Time Frame
6 months
Title
Exploratory Immunology by functional antibody assays
Description
Functional antibody assays
Time Frame
6 months
Title
Exploratory Immunology: anti-vector immunity
Description
Anti-vector immunity induced by 1 or 2 doses of ChAdOx1 nCoV-19
Time Frame
6 months
Title
Measure exposure to COVID-19
Description
Reported by weekly survey to collect information about cases amongst household contacts and friends, contact with the general public, infection control procedures
Time Frame
6 months
Title
Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection by PCR or NAAT
Description
Number of PCR or NAAT positive cases of COVID-19 infection
Time Frame
6 months
Title
Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection
Description
Measure of differences in viral loads between those with severe, mild, and asymptomatic PCR+ SARS-CoV-2 infections
Time Frame
6 months
Title
Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002
Description
Differences in safety, reactogenicity and immunogenicity profiles between Group 1 in COV001 and Group 5 in COV002 (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).
Time Frame
6 months
Title
Compare safety, reactogenicity and immunogenicity between different methods for measuring doses
Description
Differences in safety, reactogenicity and immunogenicity profiles between Groups 1, 2, and 5A compared with Groups, 7, 8, and 5B, C and D respectively (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).
Time Frame
6 months
Title
Assess vaccine induced mucosal immunity: Nasal mucosa IgA levels at D0 and D28 in a subset of individuals
Description
Nasal mucosa IgA levels at D0 and D28 in a subset of individuals
Time Frame
6 months
Title
Compare viral shedding on stool samples of SARS-CoV-2 PCR or NAAT positive individuals
Description
Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 PCR or NAAT positivity
Time Frame
6 months
Title
Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: differences in antibody titres
Description
Differences in antibody titres (ELISA and Neutralising antibodies) in participants who received 1 or 2 doses of ChAdOx1 nCoV-19 (groups 1, 2, 7 and 8)
Time Frame
6 months
Title
Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: longevity of immune responses
Description
Longevity of immune responses in participants who received 1 or 2 doses of ChAdOx1 nCoV-19
Time Frame
6 months
Title
Describe the impact of previous vaccination with other ChAdOx1 vectored vaccines on safety and immune responses to ChAdOx1 nCoV-19
Description
Differences reactogenicity profile, antibody titres and T-cell responses between groups 5d and 11 and their relationship with anti-vector neutralising antibody titres.
Time Frame
6 months
Title
Assess the cell-mediated and humoral immunogenicity profile of ChAdOx1 nCoV-19 vaccine in HIV infected adults
Description
Cell-mediated and humoral responses against SARS-Cov-2 These will be measured by the following: Proportion of seroconversion to antibodies (Ab) against SARS-CoV-2 spike protein measured by ELISA. Interferon-gamma enzyme linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein Intracellular Cytokine analyses of CD4 and CD8-specific SARS-CoV-2 spike protein responses Further exploratory immunology including immune responses to a further dose administered via the NHS national roll out
Time Frame
6 months
Title
Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults: CD4 count-vaccine immune responses
Description
Relationship between nadir CD4 count vs vaccine immune responses
Time Frame
6 months
Title
Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults: age vs vaccine immune responses
Description
Relationship between age at enrolment and vaccine immune response
Time Frame
6 months
Title
Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults
Description
Immune responses to ChAdOx1 nCoV-19 (assessed as described above)
Time Frame
6 months
Title
Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in HIV infected adults
Description
Measured by the following: Occurrence of serious adverse events (SAEs) throughout the study duration Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination Occurrence of solicited systemic signs and symptoms for 7 days following each vaccination Occurrence of unsolicited AEs for 28 days following each vaccination
Time Frame
Study duration (12 months from last vaccination)
Title
To assess Impact of vaccination on HIV reservoirs
Description
Change in Total HIV DNA copies per million CD4 T cells
Time Frame
Study duration (12 months from last vaccination)
Title
To assess immunological correlates of protection in relation to occurrence of COVID-19 disease in ChAdOx1 nCoV-19 recipients
Description
Immunological endpoints (antibody & cellular responses to SARS-COV2 spike protein) and COVID-19 disease endpoints (SARS-COV2 PCR positivity plus symptoms) in ChAdOx1 nCoV-19 recipients
Time Frame
Throughout the study, average of 18 months]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults aged 18 - 55 years (groups 4, 5, 6 and 11) Adults aged 56-69 years (groups 1, 7, and 9) Adults aged 70 years and older (groups 2, 8, and 10) Able and willing (in the Investigator's opinion) to comply with all study requirements. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures. For females of childbearing potential only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination. Agreement to refrain from blood donation during the course of the study. Provide written informed consent. Additional Inclusion criteria to Group 12 (HIV sub-study): HIV positive Receiving antiretroviral therapy Undetectable HIV viral load CD4>350 cells/mL Exclusion Criteria: • Participation in COVID-19 prophylactic drug trials for the duration of the study. Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The COV002 study team should be informed as soon as possible. • Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study. Note: Disclosure of serostatus post enrolment may accidently unblind participants to group allocation. Participation in COV002 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination, with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccination. Participants will be encouraged to receive these vaccinations at least 7 days before or after their study vaccine. Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). This exclusion criteria will not apply to group 11, as recruitment will be targeted at those volunteers who previously received a ChAdOx1 vectored vaccine. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. Any confirmed or suspected immunosuppressive or immunodeficient state (except group 12, where HIV infected participants are allowed); asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days) History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY Any history of angioedema. Any history of anaphylaxis. Pregnancy, lactation or willingness/intention to become pregnant during the study. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). History of serious psychiatric condition likely to affect participation in the study. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) Suspected or known current alcohol or drug dependency. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed) History of laboratory confirmed COVID-19 (except groups 5d, 5e, 5f, 9, 10 and 11). Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 5e, 5f, 9, 10 and 11) NB: volunteers with previous NAAT positive results are also allowed in groups 9, 10 and 11 Additional Exclusion criteria to Groups 4, 6, 9 and 10 History of allergic disease or reactions likely to be exacerbated by Paracetamol Note: Caution should be taken when recommending paracetamol to adults who already take paracetamol chronically Re-vaccination exclusion criteria (two-dose groups only) Anaphylactic reaction following administration of vaccine Pregnancy. An exception to this will be prior to receipt of a booster dose at extra visit B. If a pregnant woman has discussed vaccination with their usual clinician (e.g. GP) and chooses to receive a COVID-19 vaccination, this may be administered by the trial team as part of extra visit B. (Protocol 19.0) or as part of the provision of treatment to controls. Any AE that in the opinion of the Investigator may affect the safety of the participant or the interpretation of the study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Pollard, Prof
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
St Georges University Hospital NHS Foundation Trust
City
London
State/Province
Tooting
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
University Hospitals Bristol and Weston NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS1 3NU
Country
United Kingdom
Facility Name
North Bristol NHS Trust
City
Bristol
Country
United Kingdom
Facility Name
NIHR Cambridge Clinical Research Facility
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
NHS Lothian, Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Glasgow University and NHS Greater Glasgow & Clyde, New Lister Building, Glasgow Royal Infirmary & Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Facility Name
Liverpool School of Tropical Medicine (LSTM), Accelerator Research Clinic. Clinical Sciences Accelerator
City
LIverpool
ZIP/Postal Code
L7 8XZ
Country
United Kingdom
Facility Name
London North West University Healthcare Trust (LNWUH), Northwick Park Hospital
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust, Department of Infection, St Thomas Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Public Health Wales
City
Newport
ZIP/Postal Code
NP18 3XQ
Country
United Kingdom
Facility Name
University of Nottingham Health Service, Cripps Health Centre, University Park
City
Nottingham
ZIP/Postal Code
NG7 2QW
Country
United Kingdom
Facility Name
CCVTM, University of Oxford, Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals, Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2RX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35192543
Citation
Ogbe A, Pace M, Bittaye M, Tipoe T, Adele S, Alagaratnam J, Aley PK, Ansari MA, Bara A, Broadhead S, Brown A, Brown H, Cappuccini F, Cinardo P, Dejnirattisai W, Ewer KJ, Fok H, Folegatti PM, Fowler J, Godfrey L, Goodman AL, Jackson B, Jenkin D, Jones M, Longet S, Makinson RA, Marchevsky NG, Mathew M, Mazzella A, Mujadidi YF, Parolini L, Petersen C, Plested E, Pollock KM, Rajeswaran T, Ramasamy MN, Rhead S, Robinson H, Robinson N, Sanders H, Serrano S, Tipton T, Waters A, Zacharopoulou P, Barnes E, Dunachie S, Goulder P, Klenerman P, Screaton GR, Winston A, Hill AV, Gilbert SC, Carroll M, Pollard AJ, Fidler S, Fox J, Lambe T, Frater J. Durability of ChAdOx1 nCoV-19 vaccination in people living with HIV. JCI Insight. 2022 Apr 8;7(7):e157031. doi: 10.1172/jci.insight.157031.
Results Reference
derived
PubMed Identifier
34480858
Citation
Flaxman A, Marchevsky NG, Jenkin D, Aboagye J, Aley PK, Angus B, Belij-Rammerstorfer S, Bibi S, Bittaye M, Cappuccini F, Cicconi P, Clutterbuck EA, Davies S, Dejnirattisai W, Dold C, Ewer KJ, Folegatti PM, Fowler J, Hill AVS, Kerridge S, Minassian AM, Mongkolsapaya J, Mujadidi YF, Plested E, Ramasamy MN, Robinson H, Sanders H, Sheehan E, Smith H, Snape MD, Song R, Woods D, Screaton G, Gilbert SC, Voysey M, Pollard AJ, Lambe T; Oxford COVID Vaccine Trial group. Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002). Lancet. 2021 Sep 11;398(10304):981-990. doi: 10.1016/S0140-6736(21)01699-8. Epub 2021 Sep 1.
Results Reference
derived
PubMed Identifier
34153264
Citation
Frater J, Ewer KJ, Ogbe A, Pace M, Adele S, Adland E, Alagaratnam J, Aley PK, Ali M, Ansari MA, Bara A, Bittaye M, Broadhead S, Brown A, Brown H, Cappuccini F, Cooney E, Dejnirattisai W, Dold C, Fairhead C, Fok H, Folegatti PM, Fowler J, Gibbs C, Goodman AL, Jenkin D, Jones M, Makinson R, Marchevsky NG, Mujadidi YF, Nguyen H, Parolini L, Petersen C, Plested E, Pollock KM, Ramasamy MN, Rhead S, Robinson H, Robinson N, Rongkard P, Ryan F, Serrano S, Tipoe T, Voysey M, Waters A, Zacharopoulou P, Barnes E, Dunachie S, Goulder P, Klenerman P, Screaton GR, Winston A, Hill AVS, Gilbert SC, Pollard AJ, Fidler S, Fox J, Lambe T; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in HIV infection: a single-arm substudy of a phase 2/3 clinical trial. Lancet HIV. 2021 Aug;8(8):e474-e485. doi: 10.1016/S2352-3018(21)00103-X. Epub 2021 Jun 18.
Results Reference
derived
PubMed Identifier
33798499
Citation
Emary KRW, Golubchik T, Aley PK, Ariani CV, Angus B, Bibi S, Blane B, Bonsall D, Cicconi P, Charlton S, Clutterbuck EA, Collins AM, Cox T, Darton TC, Dold C, Douglas AD, Duncan CJA, Ewer KJ, Flaxman AL, Faust SN, Ferreira DM, Feng S, Finn A, Folegatti PM, Fuskova M, Galiza E, Goodman AL, Green CM, Green CA, Greenland M, Hallis B, Heath PT, Hay J, Hill HC, Jenkin D, Kerridge S, Lazarus R, Libri V, Lillie PJ, Ludden C, Marchevsky NG, Minassian AM, McGregor AC, Mujadidi YF, Phillips DJ, Plested E, Pollock KM, Robinson H, Smith A, Song R, Snape MD, Sutherland RK, Thomson EC, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Williams CJ, Hill AVS, Lambe T, Gilbert SC, Voysey M, Ramasamy MN, Pollard AJ; COVID-19 Genomics UK consortium; AMPHEUS Project; Oxford COVID-19 Vaccine Trial Group. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial. Lancet. 2021 Apr 10;397(10282):1351-1362. doi: 10.1016/S0140-6736(21)00628-0. Epub 2021 Mar 30.
Results Reference
derived
PubMed Identifier
33617777
Citation
Voysey M, Costa Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Clutterbuck EA, Collins AM, Cutland CL, Darton TC, Dheda K, Dold C, Duncan CJA, Emary KRW, Ewer KJ, Flaxman A, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Galiza E, Goodman AL, Green CM, Green CA, Greenland M, Hill C, Hill HC, Hirsch I, Izu A, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Libri V, Lillie PJ, Marchevsky NG, Marshall RP, Mendes AVA, Milan EP, Minassian AM, McGregor A, Mujadidi YF, Nana A, Padayachee SD, Phillips DJ, Pittella A, Plested E, Pollock KM, Ramasamy MN, Ritchie AJ, Robinson H, Schwarzbold AV, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, White T, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials. Lancet. 2021 Mar 6;397(10277):881-891. doi: 10.1016/S0140-6736(21)00432-3. Epub 2021 Feb 19. Erratum In: Lancet. 2021 Mar 6;397(10277):880.
Results Reference
derived
PubMed Identifier
33335323
Citation
Ewer KJ, Barrett JR, Belij-Rammerstorfer S, Sharpe H, Makinson R, Morter R, Flaxman A, Wright D, Bellamy D, Bittaye M, Dold C, Provine NM, Aboagye J, Fowler J, Silk SE, Alderson J, Aley PK, Angus B, Berrie E, Bibi S, Cicconi P, Clutterbuck EA, Chelysheva I, Folegatti PM, Fuskova M, Green CM, Jenkin D, Kerridge S, Lawrie A, Minassian AM, Moore M, Mujadidi Y, Plested E, Poulton I, Ramasamy MN, Robinson H, Song R, Snape MD, Tarrant R, Voysey M, Watson MEE, Douglas AD, Hill AVS, Gilbert SC, Pollard AJ, Lambe T; Oxford COVID Vaccine Trial Group. T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial. Nat Med. 2021 Feb;27(2):270-278. doi: 10.1038/s41591-020-01194-5. Epub 2020 Dec 17. Erratum In: Nat Med. 2021 Jun;27(6):1116.
Results Reference
derived
PubMed Identifier
33306989
Citation
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum In: Lancet. 2021 Jan 9;397(10269):98.
Results Reference
derived
PubMed Identifier
33220855
Citation
Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, Voysey M, Aley PK, Angus B, Babbage G, Belij-Rammerstorfer S, Berry L, Bibi S, Bittaye M, Cathie K, Chappell H, Charlton S, Cicconi P, Clutterbuck EA, Colin-Jones R, Dold C, Emary KRW, Fedosyuk S, Fuskova M, Gbesemete D, Green C, Hallis B, Hou MM, Jenkin D, Joe CCD, Kelly EJ, Kerridge S, Lawrie AM, Lelliott A, Lwin MN, Makinson R, Marchevsky NG, Mujadidi Y, Munro APS, Pacurar M, Plested E, Rand J, Rawlinson T, Rhead S, Robinson H, Ritchie AJ, Ross-Russell AL, Saich S, Singh N, Smith CC, Snape MD, Song R, Tarrant R, Themistocleous Y, Thomas KM, Villafana TL, Warren SC, Watson MEE, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Faust SN, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2021 Dec 19;396(10267):1979-1993. doi: 10.1016/S0140-6736(20)32466-1. Epub 2020 Nov 19. Erratum In: Lancet. 2021 Dec 19;396(10267):1978. Lancet. 2021 Apr 10;397(10282):1350.
Results Reference
derived

Learn more about this trial

Investigating a Vaccine Against COVID-19

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