Chikungunya Virus InfectionPhase 4CHIK-RE-VACNCT06928753
Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana
A Phase 4 study testing IXCHIQ and VIMKUNYA in people with Chikungunya Virus Infection, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in 2 countries.
Trial summary
In the context of the ongoing chikungunya epidemic in Réunion Island and the anticipated epidemic in French Guiana, the investigators propose an ambispective study to evaluate the real-world effectiveness, safety, and immunogenicity of the recommended vaccines, IXCHIQ® and VIMKUNYA®, as defined by the French National… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chikungunya Virus Infection
- What is being tested?
- IXCHIQ and VIMKUNYA
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,505 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Apr 2025to Dec 2027
- Phase
- Phase 4
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Retrospective study VIMKUNYA or IXCHIQ
- Adult (Aged 18 or above)
- Adult (Aged 18 or above) eligible for anti-chikungunya vaccination according to French High Health Authority (HAS)
- Prospective study
- VIMKUNYA: Adult (Aged 18 or above) eligible for anti-chikungunya vaccination according to French High Health Authority (HAS)
- IXCHIQ: Adult (Aged 18 -64) eligible for anti-chikungunya vaccination according to French High Health Authority (HAS) Eligibility Criteria common to both groups
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- Agreeing to participate in study
- Beneficiary of French social security coverage
- Signature of informed consent form
Who cannot join
- Pregnant or breastfeeding women entering the prospective study
- Vaccine (IXCHIQ or VIMKUNYA) contraindication for patients undergoing medical treatment
- Persons under guardianship, curatorship or safeguard of justice
- Anyone who has received immunoglobulin or a blood or plasma transfusion 3 months prior to vaccine administration
- Missing French Social security coverage
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
French Guiana1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Guyane
Cayenne
Paul LE TURNIER, MD
Paul LE TURNIER, MD
Reunion1 site
- Active, not recruiting
Centre Hospitalier Universitaire de La Réunion
Saint-Denis
About this study
Official title: Real-world Effectiveness, Safety, and Immunogenicity of Chikungunya Vaccination During an Epidemic Period: an Ambispective Study in Réunion Island and French Guiana.
In the context of the ongoing chikungunya epidemic in Réunion Island and the anticipated epidemic in French Guiana, the investigators propose an ambispective study to evaluate the real-world effectiveness, safety, and immunogenicity of the recommended vaccines, IXCHIQ® and VIMKUNYA®, as defined by the French National Authority for Health (HAS).
- Conditions
- Chikungunya Virus Infection
- Being tested
- IXCHIQ, VIMKUNYA
- Keywords
- prophylaxis, vaccine effectiveness, safety, efficacy, chikungunya
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IXCHIQBiological
Group of vaccinated arm will be with the IXCHIQ vaccine
VIMKUNYABiological
Other group of vaccinated arm will be with the VIMKUNYA vaccine
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated group | Experimental | Patients who will be vaccinated with the IXCHIQ vaccine or the VIMKUNYA vaccine Receives: Biological: IXCHIQ; Biological: VIMKUNYA |
| Non-vaccinated group | No intervention | Patient who will not be vaccinated |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the vaccine effectiveness at 6 months
Vaccine effectiveness defined at 6 months as the difference in attack rate between unvaccinated and vaccinated participants divided by the attack rate in unvaccinated participants
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start18 Apr 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chikungunya Virus InfectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, ARS La Réunion, Direction Générale de l'Offre de Soins, Valneva Austria GmbH, Bavarian Nordic, Agence Régionale de Santé Guyane, Région Réunion
- Responsible party
- Sponsor
- Investigators
- Patrick GERARDIN, MD, Study director, CHU La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928753
- Sponsor's protocol ID
- 2025/CHU/12
- Other IDs
- 2025-521307-43-00, 2025
- Acronym
- CHIK-RE-VAC
- Status last verified
- Sep 2026
- First submitted
- 8 Apr 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No