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Research Study to Assess New Chikungunya and Zika Vaccines in Healthy Adults in Mexico.

Primary Purpose

Chikungunya, Zika

Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
CHIK low dose
CHIK mid dose
CHIK high dose
ZIKA low dose
ZIKA mid dose
ZIKA high dose
Saline placebo
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chikungunya focused on measuring Vaccine, ChAdOx1, Chikungunya, Zika, Mexico

Eligibility Criteria

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

Inclusion Criteria:

  1. Healthy men aged 18 to 50 (inclusive) years at the time of screening.
  2. Healthy women aged 18 to 50 (inclusive) of child-bearing potential who agree to practice continuous effective contraception (see below) during the study and test negative for pregnancy on the day(s) of screening and vaccination.
  3. Are residents of the metropolitan area of Monterrey, Nuevo León.
  4. Provide written informed consent for participation in the study.
  5. Able and willing (in the Investigator's opinion) to comply with all study requirements.
  6. Agreement to inform study team of any impending vaccinations either before or during participation in the study.
  7. Agreement to refrain from blood donation during the course of the study.
  8. Agreement to refrain from receipt of any alphavirus or flavivirus vaccine throughout the duration of the study (e.g. investigational or licensed Yellow Fever, Japanese Encephalitis, Tick Borne Encephalitis or Dengue virus vaccines).

Exclusion Criteria:

  1. Participation in another clinical trial in the 30 days preceding enrolment or during the study period.
  2. Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccine, Chikungunya virus vaccine, Zika virus vaccine, Dengue virus vaccine).
  3. Prior receipt of any vaccines administered ≤30 days before enrolment and/or planned during the during the study.
  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. Any history of anaphylaxis in relation to vaccination.
  7. History of autoimmune disease.
  8. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  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 at present or during the last 6 months.
  14. Suspected or known current alcohol abuse. For men, intake greater than 5 drinks on a single occasion or more than 15 drinks per week; and for women, more than 4 drinks on a single occasion or more than 8 drinks per week. One drink =14 grams of pure alcohol.
  15. Suspected or known injecting drug abuse in the 5 years preceding enrolment.
  16. Seropositive for hepatitis B surface antigen (HBsAg).
  17. Seropositive for hepatitis C virus (antibodies to HCV).
  18. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis.
  19. Has history of chronic or acute severe neurologic condition. Including: Neurologic and Neuroinflammatory Disorders: ADEM, including site specific variants, Cranial Nerve Disorders (including paralyses/paresis), GBS (including Miller Fisher Syndrome and other variants), Immune-mediated Peripheral Neuropathies and Plexopathies, Optic Neuritis, Multiple Sclerosis, Narcolepsy, Transverse Myelitis, meningitis, or meningoencephalitis.
  20. 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.
  21. Seropositivity or cross-reactivity to Chikungunya virus, Zika virus or Dengue virus on screening tests.

Sites / Locations

  • Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León.

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 Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

CHIK low dose

CHIK mid dose

CHIK high dose

ZIKA low dose

ZIKA mid dose

ZIKA high dose

CHIK ZIKA low dose

CHIK ZIKA mid dose

CHIK ZIKA high dose

Placebo

Arm Description

Volunteers will receive a single dose of 5x10^9 vp ChAdOx1 Chik delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator

Volunteers will receive a single dose of 2.5x10^10 vp ChAdOx1 Chik delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator

Volunteers will receive a single dose of 5x10^10 vp ChAdOx1 Chik delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator

Volunteers will receive a single dose of 5x10^9 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator

Volunteers will receive a single dose of 2.5x10^10 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator

Volunteers will receive a single dose of 5x10^10 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator

Volunteers will receive a single dose of 5x10^9 vp ChAdOx1 Chik and 5x10^9 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator

Volunteers will receive a single dose of 2.5x10^10 vp ChAdOx1 Chik and 2.5x10^10 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator

Volunteers will receive a single dose of 5x10^10 vp ChAdOx1 Chik and 5x10^10 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator

Volunteers will receive a single dose of isotonic saline solution (0.9%) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator

Outcomes

Primary Outcome Measures

Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of local reactogenicity signs and symptoms
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination.
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of solicited systemic reactogenicity signs and symptoms
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination.
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of unsolicited adverse events
Occurrence of unsolicited adverse events for 28 days following vaccination
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants through standard blood tests (full blood count, liver and kidney function tests)
Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of serious adverse events during the whole study duration
Occurrence of serious adverse events during the whole study duration

Secondary Outcome Measures

Assess the humoral immunogenicity of the candidate vaccines ChAdOx1 Chik and ChAdOx1 Zika via PRNT50
Plaque-reduction neutralisation tests at 50% (PRNT50) against chikungunya and Zika virus.
Assess the humoral immunogenicity of the candidate vaccines ChAdOx1 Chik and ChAdOx1 Zika via IgG ELISA antibody titres
IgG ELISA antibody titres against proteins of Chikungunya and Zika virus

Full Information

First Posted
June 17, 2020
Last Updated
March 22, 2022
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT04440774
Brief Title
Research Study to Assess New Chikungunya and Zika Vaccines in Healthy Adults in Mexico.
Official Title
A Single Centre, Double-blind, Double-dummy Placebo-controlled, Randomised Phase Ib Study to Evaluate the Safety & Immunogenicity of the Candidate Chikungunya Vaccine ChAdOx1 Chik & the Zika Vaccine ChAdOx1 Zika in Healthy Adults in Mexico
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 23, 2020 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase Ib, single centre, double-blind, double-dummy placebo-controlled, randomised, stepwise dose escalated, vaccine trial to assess the safety and immunogenicity of the candidate ChAdOx1 Chik and ChAdOx1 Zika vaccines, given as a standalone vaccines or in co-administration. Healthy volunteers aged 18-50 years old, residents of the metropolitan area of Monterrey (Mexico), will be recruited as participants
Detailed Description
This trial consists of 4 intervention arms according to the vaccination product: 1) ChAdOx1 Chik, 2) ChAdOx1 Zika, 3) ChAdOx1 Chik and ChAdOx1 Zika as contralateral co-administration, and 4) placebo. There will be a total of 120 participants divided in ten study groups with 12 participants per group (Table 5.1). Groups 1 to 3 will receive ChAdOx1 Chik + placebo administered contralaterally, Groups 4 to 6 will receive ChAdOx1 Zika + placebo administered contralaterally, and Groups 7 to 9 will receive both ChAdOx1 Chik and ChAdOx1 Zika administered contralaterally. Group 10 will receive placebo in both arms. Enrolment into this study will be implemented in a step-wise dose escalation manner. Participants will be first recruited into the vaccination groups at the lowest dose (Groups 1, 4 and 7). It is only after completion of these low dose groups and upon satisfactory interim clinical safety reviews that participants will be enrolled into the mid dose groups (Groups 2, 5 and 8). Participants in the high dose groups (Groups 3, 6 and 9) will be enrolled last, after completion and interim clinical safety reviews from the mid dose groups. Participants allocated to the Placebo group (Group 10) will be evenly distributed across the dose escalation model. Randomisation procedures will be implemented accordingly, at a ratio of 3:3:3:1 for each of the four intervention arms. The study involves a total of 9 visits (screening inclusive) and follow up will be undertaken for 6 months after vaccination day Innovate UK (project number 971557)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya, Zika
Keywords
Vaccine, ChAdOx1, Chikungunya, Zika, Mexico

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHIK low dose
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose of 5x10^9 vp ChAdOx1 Chik delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator
Arm Title
CHIK mid dose
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose of 2.5x10^10 vp ChAdOx1 Chik delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator
Arm Title
CHIK high dose
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose of 5x10^10 vp ChAdOx1 Chik delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator
Arm Title
ZIKA low dose
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose of 5x10^9 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator
Arm Title
ZIKA mid dose
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose of 2.5x10^10 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator
Arm Title
ZIKA high dose
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose of 5x10^10 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator
Arm Title
CHIK ZIKA low dose
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose of 5x10^9 vp ChAdOx1 Chik and 5x10^9 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator
Arm Title
CHIK ZIKA mid dose
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose of 2.5x10^10 vp ChAdOx1 Chik and 2.5x10^10 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator
Arm Title
CHIK ZIKA high dose
Arm Type
Experimental
Arm Description
Volunteers will receive a single dose of 5x10^10 vp ChAdOx1 Chik and 5x10^10 vp ChAdOx1 Zika delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Volunteers will receive a single dose of isotonic saline solution (0.9%) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo comparator
Intervention Type
Biological
Intervention Name(s)
CHIK low dose
Intervention Description
A single dose of 5x10^9 vp ChAdOx1 Chik
Intervention Type
Biological
Intervention Name(s)
CHIK mid dose
Intervention Description
A single dose of 2.5x10^10 vp ChAdOx1 Chik
Intervention Type
Biological
Intervention Name(s)
CHIK high dose
Intervention Description
A single dose of 5x10^10 vp ChAdOx1 Chik
Intervention Type
Biological
Intervention Name(s)
ZIKA low dose
Intervention Description
A single dose of 5x10^9 vp ChAdOx1 Zika
Intervention Type
Biological
Intervention Name(s)
ZIKA mid dose
Intervention Description
A single dose of 2.5x10^10 vp ChAdOx1 Zika
Intervention Type
Biological
Intervention Name(s)
ZIKA high dose
Intervention Description
A single dose of 5x10^10 vp ChAdOx1 Zika
Intervention Type
Biological
Intervention Name(s)
Saline placebo
Intervention Description
A single dose of isotonic saline solution (0.9%)
Primary Outcome Measure Information:
Title
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of local reactogenicity signs and symptoms
Description
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination.
Time Frame
7 days post vaccination
Title
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of solicited systemic reactogenicity signs and symptoms
Description
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination.
Time Frame
7 days post vaccination
Title
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of unsolicited adverse events
Description
Occurrence of unsolicited adverse events for 28 days following vaccination
Time Frame
28 days post vaccination
Title
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants through standard blood tests (full blood count, liver and kidney function tests)
Description
Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Time Frame
28 days post vaccination
Title
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of serious adverse events during the whole study duration
Description
Occurrence of serious adverse events during the whole study duration
Time Frame
6 months post vaccination
Secondary Outcome Measure Information:
Title
Assess the humoral immunogenicity of the candidate vaccines ChAdOx1 Chik and ChAdOx1 Zika via PRNT50
Description
Plaque-reduction neutralisation tests at 50% (PRNT50) against chikungunya and Zika virus.
Time Frame
6 months post vaccination
Title
Assess the humoral immunogenicity of the candidate vaccines ChAdOx1 Chik and ChAdOx1 Zika via IgG ELISA antibody titres
Description
IgG ELISA antibody titres against proteins of Chikungunya and Zika virus
Time Frame
6 months post 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 men aged 18 to 50 (inclusive) years at the time of screening. Healthy women aged 18 to 50 (inclusive) of child-bearing potential who agree to practice continuous effective contraception (see below) during the study and test negative for pregnancy on the day(s) of screening and vaccination. Are residents of the metropolitan area of Monterrey, Nuevo León. Provide written informed consent for participation in the study. Able and willing (in the Investigator's opinion) to comply with all study requirements. Agreement to inform study team of any impending vaccinations either before or during participation in the study. Agreement to refrain from blood donation during the course of the study. Agreement to refrain from receipt of any alphavirus or flavivirus vaccine throughout the duration of the study (e.g. investigational or licensed Yellow Fever, Japanese Encephalitis, Tick Borne Encephalitis or Dengue virus vaccines). Exclusion Criteria: Participation in another clinical trial in the 30 days preceding enrolment or during the study period. Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccine, Chikungunya virus vaccine, Zika virus vaccine, Dengue virus vaccine). Prior receipt of any vaccines administered ≤30 days before enrolment and/or planned during the during the study. 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 anaphylaxis in relation to vaccination. History of autoimmune disease. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema. 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 at present or during the last 6 months. Suspected or known current alcohol abuse. For men, intake greater than 5 drinks on a single occasion or more than 15 drinks per week; and for women, more than 4 drinks on a single occasion or more than 8 drinks per week. One drink =14 grams of pure alcohol. Suspected or known injecting drug abuse in the 5 years preceding enrolment. Seropositive for hepatitis B surface antigen (HBsAg). Seropositive for hepatitis C virus (antibodies to HCV). Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis. Has history of chronic or acute severe neurologic condition. Including: Neurologic and Neuroinflammatory Disorders: ADEM, including site specific variants, Cranial Nerve Disorders (including paralyses/paresis), GBS (including Miller Fisher Syndrome and other variants), Immune-mediated Peripheral Neuropathies and Plexopathies, Optic Neuritis, Multiple Sclerosis, Narcolepsy, Transverse Myelitis, meningitis, or meningoencephalitis. 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. Seropositivity or cross-reactivity to Chikungunya virus, Zika virus or Dengue virus on screening tests.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abiel Homero Mascareñas de los Santos, MD
Organizational Affiliation
Hospital Universitario "Dr. José Eleuterio González" Universidad Autónoma de Nuevo León
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León.
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

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Research Study to Assess New Chikungunya and Zika Vaccines in Healthy Adults in Mexico.

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