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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness, Safety, and Immunogenicity of Chikungunya Vaccination During an Epidemic Period: an Ambispective Study in Réunion Island and French Guiana.
- ClinicalTrials.gov ID
- NCT06928753
- Acronym / sponsor ID
- CHIK-RE-VAC / 2025/CHU/12
- Conditions
- Chikungunya Virus Infection
- Keywords
- prophylaxis, vaccine effectiveness, safety, efficacy, chikungunya
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,505 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, 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
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Apr 2025 (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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated group | Experimental | Biological: IXCHIQ, Biological: VIMKUNYAPatients who will be vaccinated with the IXCHIQ vaccine or the VIMKUNYA vaccine |
| Non-vaccinated group | No intervention | –Patient who will not be vaccinated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| IXCHIQGroup of vaccinated arm will be with the IXCHIQ vaccine | Biological | Vaccinated group |
| VIMKUNYAOther group of vaccinated arm will be with the VIMKUNYA vaccine | Biological | Vaccinated group |
Primary outcome
To measure the vaccine effectiveness at 6 months
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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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.
Patrick GERARDIN, MD study director
CHU La Réunion
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in French Guiana, Reunion. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick GERARDIN, MD ((262) 2 62 35 9435, patrick.gerardin@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the vaccine effectiveness at 6 months (time frame: 6 months). 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 28 Sep 2026.