ClinicalTrials.gg
RecruitingNCT06928753CHIK-RE-VACUpdated Sep 28, 2026

Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana

A Phase 4 interventional study of IXCHIQ and VIMKUNYA in Chikungunya Virus Infection, sponsored by Centre Hospitalier Universitaire de la Réunion. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Phase 4, Interventional, and Other

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Updated Sep 28, 2026Sponsor changedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
1,505
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 Authority for Health (HAS).

02

Conditions studied

  • Chikungunya Virus Infection

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Keywords

  • prophylaxis
  • vaccine effectiveness
  • safety
  • efficacy
  • chikungunya
03

In context

Chikungunya Fever

88 studies on the registry are indexed under Chikungunya Fever; 21 are open to participants now.

This study's planned enrollment of 1,505 is above the median of 263 across 57 interventional studies indexed under Chikungunya Fever.

Browse Chikungunya Fever studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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
  • Agreeing to participate in study
  • Beneficiary of French social security coverage
  • Signature of form

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding women entering the prospective study
  • Vaccine (IXCHIQ or VIMKUNYA) 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,505 participants (estimated)

Study arms

  • Experimental
    Vaccinated group

    Patients who will be vaccinated with the IXCHIQ vaccine or the VIMKUNYA vaccine

    Biological: IXCHIQ · Biological: VIMKUNYA

  • No intervention
    Non-vaccinated group

    Patient who will not be vaccinated

Interventions

  • BiologicalIXCHIQ

    Group of vaccinated arm will be with the IXCHIQ vaccine

  • BiologicalVIMKUNYA

    Other group of vaccinated arm will be with the VIMKUNYA vaccine

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

07

Study locations

1 of 2 sites recruiting
  • Centre Hospitalier Universitaire de Guyane
    Cayenne, French Guiana
    Recruiting
    • Paul LE TURNIER, MD · Contact
    • Paul LE TURNIER, MD · Principal investigator
  • Centre Hospitalier Universitaire de La Réunion
    Saint-Denis, Reunion
    Active, not recruiting

    Not enrolling at this site.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2025 (actual). Primary completion is estimated for Jun 2027, 26 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2025
First posted
Apr 15, 2025
StartActual
Apr 18, 2025
Primary completionEst.
Jun 2027
CompletionEst.
Dec 2027
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sponsor
Collaborators added: Agence Régionale de Santé Guyane·Région Réunion; collaborators removed: Région La Réunion·ARS Guyane
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Sponsor Collaborators added: Agence Régionale de Santé Guyane·Région Réunion; collaborators removed: Région La Réunion·ARS Guyane
    + 2 other changes: description and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06928753
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
First posted
Apr 15, 2025
Start date
Apr 18, 2025
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Patrick GERARDIN, MD
Contact
patrick.gerardin@chu-reunion.fr
(262) 2 62 35 9435
Florence LEFEBVRE D'HELLENCOURT
Contact
promotion.drci@chu-reunion.fr
+262 262 75 34 71
Patrick GERARDIN, MD
study director · CHU La Réunion

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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