Research Study to Assess New Chikungunya and Zika Vaccines in Healthy Adults in Mexico.
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
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedStudy Start
First participant enrolled
October 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2022
CompletedMarch 23, 2022
September 1, 2021
1.3 years
June 17, 2020
March 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
7 days post 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.
7 days post 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
28 days post 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)
28 days post vaccination
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
6 months post vaccination
Secondary Outcomes (2)
Assess the humoral immunogenicity of the candidate vaccines ChAdOx1 Chik and ChAdOx1 Zika via PRNT50
6 months post vaccination
Assess the humoral immunogenicity of the candidate vaccines ChAdOx1 Chik and ChAdOx1 Zika via IgG ELISA antibody titres
6 months post vaccination
Study Arms (10)
CHIK low dose
EXPERIMENTALVolunteers 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
CHIK mid dose
EXPERIMENTALVolunteers 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
CHIK high dose
EXPERIMENTALVolunteers 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
ZIKA low dose
EXPERIMENTALVolunteers 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
ZIKA mid dose
EXPERIMENTALVolunteers 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
ZIKA high dose
EXPERIMENTALVolunteers 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
CHIK ZIKA low dose
EXPERIMENTALVolunteers 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
CHIK ZIKA mid dose
EXPERIMENTALVolunteers 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
CHIK ZIKA high dose
EXPERIMENTALVolunteers 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
Placebo
PLACEBO COMPARATORVolunteers 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
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León.
Monterrey, Nuevo León, 64460, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abiel Homero Mascareñas de los Santos, MD
Hospital Universitario "Dr. José Eleuterio González" Universidad Autónoma de Nuevo León
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 22, 2020
Study Start
October 23, 2020
Primary Completion
February 18, 2022
Study Completion
February 18, 2022
Last Updated
March 23, 2022
Record last verified: 2021-09