ChikungunyaPhase 1NCT04440774
Research Study to Assess New Chikungunya and Zika Vaccines in Healthy Adults in Mexico.
A Phase 1 study testing CHIK low dose, CHIK mid dose and CHIK high dose in people with Chikungunya and Zika, run by University of Oxford at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya, Zika
- What is being tested?
- CHIK low dose, CHIK mid dose and CHIK high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteMexico
- Study dates
- 23 Oct 2020to 18 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León.
Monterrey, Nuevo León, 64460
About this study
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
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
Read the 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)
- Conditions
- Chikungunya, Zika
- Being tested
- CHIK low dose, CHIK mid dose, CHIK high dose, ZIKA low dose, ZIKA mid dose
- Keywords
- Vaccine, ChAdOx1, Chikungunya, Zika, Mexico
- Medical subject headings
- Chikungunya Fever, Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHIK low doseBiological
A single dose of 5x10^9 vp ChAdOx1 Chik
CHIK mid doseBiological
A single dose of 2.5x10^10 vp ChAdOx1 Chik
CHIK high doseBiological
A single dose of 5x10^10 vp ChAdOx1 Chik
ZIKA low doseBiological
A single dose of 5x10^9 vp ChAdOx1 Zika
ZIKA mid doseBiological
A single dose of 2.5x10^10 vp ChAdOx1 Zika
ZIKA high doseBiological
A single dose of 5x10^10 vp ChAdOx1 Zika
Saline placeboBiological
A single dose of isotonic saline solution (0.9%)
| Study group | Role | What they receive |
|---|---|---|
| CHIK low dose | Experimental | 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 Receives: Biological: CHIK low dose |
| CHIK mid dose | Experimental | 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 Receives: Biological: CHIK mid dose |
| CHIK high dose | Experimental | 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 Receives: Biological: CHIK high dose |
| ZIKA low dose | Experimental | 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 Receives: Biological: ZIKA low dose |
| ZIKA mid dose | Experimental | 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 Receives: Biological: ZIKA mid dose |
| ZIKA high dose | Experimental | 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 Receives: Biological: ZIKA high dose |
| CHIK ZIKA low dose | Experimental | 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 Receives: Biological: CHIK low dose; Biological: ZIKA low dose |
| CHIK ZIKA mid dose | Experimental | 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 Receives: Biological: CHIK mid dose; Biological: ZIKA mid dose |
| CHIK ZIKA high dose | Experimental | 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 Receives: Biological: CHIK high dose; Biological: ZIKA high dose |
| Placebo | 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 Receives: Biological: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 6 months post vaccination
Secondary outcomes (2)
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.
Measured: 6 months post vaccination
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
Measured: 6 months post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start23 Oct 2020
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChikungunyaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abiel Homero Mascareñas de los Santos, MD, Principal investigator, Hospital Universitario "Dr. José Eleuterio González" Universidad Autónoma de Nuevo León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440774
- Sponsor's protocol ID
- CHIKA01
- Status last verified
- Sep 2021
- First submitted
- 17 Jun 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04440774
- Acronym / sponsor ID
- CHIKA01
- Conditions
- Chikungunya, Zika
- Keywords
- Vaccine, ChAdOx1, Chikungunya, Zika, Mexico
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| CHIK low dose | Experimental | Biological: CHIK low doseVolunteers 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 | Experimental | Biological: CHIK mid doseVolunteers 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 | Experimental | Biological: CHIK high doseVolunteers 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 | Experimental | Biological: ZIKA low doseVolunteers 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 | Experimental | Biological: ZIKA mid doseVolunteers 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 | Experimental | Biological: ZIKA high doseVolunteers 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 | Experimental | Biological: CHIK low dose, Biological: ZIKA low doseVolunteers 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 | Experimental | Biological: CHIK mid dose, Biological: ZIKA mid doseVolunteers 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 | Experimental | Biological: CHIK high dose, Biological: ZIKA high doseVolunteers 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 comparator | Biological: Saline placeboVolunteers 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHIK low doseA single dose of 5x10^9 vp ChAdOx1 Chik | Biological | CHIK ZIKA low dose, CHIK low dose |
| CHIK mid doseA single dose of 2.5x10^10 vp ChAdOx1 Chik | Biological | CHIK ZIKA mid dose, CHIK mid dose |
| CHIK high doseA single dose of 5x10^10 vp ChAdOx1 Chik | Biological | CHIK ZIKA high dose, CHIK high dose |
| ZIKA low doseA single dose of 5x10^9 vp ChAdOx1 Zika | Biological | CHIK ZIKA low dose, ZIKA low dose |
| ZIKA mid doseA single dose of 2.5x10^10 vp ChAdOx1 Zika | Biological | CHIK ZIKA mid dose, ZIKA mid dose |
| ZIKA high doseA single dose of 5x10^10 vp ChAdOx1 Zika | Biological | CHIK ZIKA high dose, ZIKA high dose |
| Saline placeboA single dose of isotonic saline solution (0.9%) | Biological | Placebo |
Primary outcome
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of local reactogenicity signs and symptoms
Time frame: 7 days post vaccination
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
Time frame: 7 days post vaccination
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
Time frame: 28 days post vaccination
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)
Time frame: 28 days post vaccination
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
Time frame: 6 months post vaccination
Occurrence of serious adverse events during the whole study duration
2 secondary outcomes
Assess the humoral immunogenicity of the candidate vaccines ChAdOx1 Chik and ChAdOx1 Zika via PRNT50
Time frame: 6 months post vaccination
Assess the humoral immunogenicity of the candidate vaccines ChAdOx1 Chik and ChAdOx1 Zika via IgG ELISA antibody titres
Time frame: 6 months post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abiel Homero Mascareñas de los Santos, MD principal investigator
Hospital Universitario "Dr. José Eleuterio González" Universidad Autónoma de Nuevo León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHIK low dose, CHIK mid dose and CHIK high dose in people with Chikungunya and Zika, run by University of Oxford at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of local reactogenicity signs and symptoms (time frame: 7 days post vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.