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A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers

Primary Purpose

Crohn Disease, Mycobacterium Avium Subspecies Paratuberculosis

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ChAdOx2 HAV
MVA HAV
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Vaccine, MAP

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy adults aged 18 to 50 years
  2. Able and willing (in the Investigator's opinion) to comply with all study requirements
  3. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
  4. For females 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
  5. Agreement to refrain from blood donation during the course of the study
  6. Provide written informed consent

Exclusion Criteria:

  1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
  2. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data.
  3. Prior receipt of an adenoviral vectored vaccine in the last 12 months
  4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  5. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
  6. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
  7. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  8. Any history of anaphylaxis in relation to vaccination
  9. Pregnancy, lactation or willingness/intention to become pregnant during the study
  10. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  11. History of serious psychiatric condition likely to affect participation in the study
  12. Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
  13. Any other serious chronic illness requiring hospital specialist supervision
  14. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  15. Suspected or known injecting drug abuse in the 5 years preceding enrolment
  16. Seropositive for hepatitis C (antibodies to HCV)
  17. Seropositive for hepatitis B surface antigen(HBsAg)
  18. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
  19. 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
  20. Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate.

Sites / Locations

  • Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Group 6

Arm Description

Group 1 volunteers (n= 3 to 6) will be administered ChAdOx2 HAV, 5 x 10^9 vp through intramuscular route.

Group 2 volunteers (n= 3 to 6) will be administered ChAdOx2 HAV, 2.5 x 10^10 vp through intramuscular route.

Group 3 volunteers (n= 3 to 6) will be administered ChAdOx2 HAV, 5 x 10^10 vp through intramuscular route.

Group 4 volunteers (n= 3) will be administered MVA HAV, 5 x 10^7 pfu through intramuscular route.

Group 5 volunteers (n= 3) will be administered MVA HAV, 2 x 10^8 pfu through intramuscular route.

Group 6 volunteers (n= 10) will be administered ChAdOx2 HAV, 5 x 10^10 vp followed by MVA HAV, 2 x 10^8 pfu (8 weeks apart) through intramuscular route.

Outcomes

Primary Outcome Measures

Occurrence of solicited and unsolicited local and systemic adverse events
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. Change from baseline for safety laboratory measures will also be collected. Occurrence of serious adverse events will be collected during the whole study duration

Secondary Outcome Measures

Measures of Immunogenicity of ChAdOx2 HAV and MVA HAV
To assess the immunogenicity of ChAdOx2 HAV and MVA HAV in healthy adult volunteers when administered alone and in a prime-boost regimen

Full Information

First Posted
January 19, 2017
Last Updated
February 24, 2020
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT03027193
Brief Title
A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers
Official Title
A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Mycobacterium Avium Subspecies Paratuberculosis (MAP) Vaccines ChAdOx2 HAV and MVA HAV in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
January 16, 2020 (Actual)

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

5. Study Description

Brief Summary
A phase I dose escalation study to assess the safety and immunogenicity of the candidate vaccines ChAdOx2 HAV and MVA HAV in healthy volunteers. Volunteers will be recruited and vaccinated in Oxford, England. All vaccinations will be administered intramuscularly. Three different doses of the ChAdOx2 HAV will be tested (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp). MVA HAV will be assessed at 2 different doses (5x10^7 and 2x10^8 pfu) The total duration of the study will be 52 weeks from the day of enrolment for volunteers receiving ChAdOx2 HAV only, 12 weeks for volunteers receiving MVA HAV only and 20 weeks for volunteers receiving ChAdOx2 HAV and MVA HAV.
Detailed Description
This is a phase I, open label, dose escalation trial to assess the safety and immunogenicity of the ChAdOx2 and MVA HAV vaccines against Mycobacterium avium subspecies paratuberculosis (MAP) in healthy volunteers There will be 5 study groups with a total of 28 volunteers. ChAdOx2 HAV will be administered intramuscularly as a single vaccination at 3 different doses: 5x10^9 vp (group 1), 2.5x10^10 (group 2) and 5x10^10 vp (group 3) and as a prime vaccine in group 6 (prime/boost group). MVA HAV will be administered intramuscularly as a single vaccination at 2 different doses: 5x10^7 pfu (group 4), 2x10^8 pfu (group 5) and as a boost vaccine in group 6 (prime/boost group) Vaccination of groups will be sequential from Group 1 to Group 6 with interim safety reviews prior to dose escalation Volunteers will be recruited and undergo screening visits, vaccination and clinic visits post-vaccination at the trial site. Blood samples for safety and immunology purposes will be performed on the visit time points indicated in the schedule of attendances. Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Mycobacterium Avium Subspecies Paratuberculosis
Keywords
Vaccine, MAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1 volunteers (n= 3 to 6) will be administered ChAdOx2 HAV, 5 x 10^9 vp through intramuscular route.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Group 2 volunteers (n= 3 to 6) will be administered ChAdOx2 HAV, 2.5 x 10^10 vp through intramuscular route.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Group 3 volunteers (n= 3 to 6) will be administered ChAdOx2 HAV, 5 x 10^10 vp through intramuscular route.
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Group 4 volunteers (n= 3) will be administered MVA HAV, 5 x 10^7 pfu through intramuscular route.
Arm Title
Group 5
Arm Type
Experimental
Arm Description
Group 5 volunteers (n= 3) will be administered MVA HAV, 2 x 10^8 pfu through intramuscular route.
Arm Title
Group 6
Arm Type
Experimental
Arm Description
Group 6 volunteers (n= 10) will be administered ChAdOx2 HAV, 5 x 10^10 vp followed by MVA HAV, 2 x 10^8 pfu (8 weeks apart) through intramuscular route.
Intervention Type
Biological
Intervention Name(s)
ChAdOx2 HAV
Intervention Description
The ChAdOx2 HAV vaccine consists of the replication-deficient simian adenovirus vector ChAdOx2, containing the Mycobacterium avium subspecies paratuberculosis (MAP) antigens
Intervention Type
Biological
Intervention Name(s)
MVA HAV
Intervention Description
The MVA HAV vaccine consists of the replication deficient modified vaccinia virus Ankara (MVA) containing the Mycobacterium avium subspecies paratuberculosis (MAP) antigens.
Primary Outcome Measure Information:
Title
Occurrence of solicited and unsolicited local and systemic adverse events
Description
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. Change from baseline for safety laboratory measures will also be collected. Occurrence of serious adverse events will be collected during the whole study duration
Time Frame
up to 28 days following vaccination
Secondary Outcome Measure Information:
Title
Measures of Immunogenicity of ChAdOx2 HAV and MVA HAV
Description
To assess the immunogenicity of ChAdOx2 HAV and MVA HAV in healthy adult volunteers when administered alone and in a prime-boost regimen
Time Frame
Approximately 2 months post each vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults aged 18 to 50 years 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 For females 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 Exclusion Criteria: Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data. Prior receipt of an adenoviral vectored vaccine in the last 12 months 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, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed) History of allergic disease or reactions likely to be exacerbated by any component of the vaccine Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema. Any history of anaphylaxis in relation to vaccination Pregnancy, lactation or willingness/intention to become pregnant during the study History of 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 (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture Any other serious chronic illness requiring hospital specialist supervision Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week Suspected or known injecting drug abuse in the 5 years preceding enrolment Seropositive for hepatitis C (antibodies to HCV) Seropositive for hepatitis B surface antigen(HBsAg) Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis 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 Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian V Hill, DPhill FRCP
Organizational Affiliation
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hosptal, Oxford, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers

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