Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana (CHIK-RE-VAC)

September 10, 2026 updated by: Centre Hospitalier Universitaire de la Réunion

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, we 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1505

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • French Guiana
      • Cayenne, French Guiana
        • Recruiting
        • Centre Hospitalier Universitaire de Guyane
        • Contact:
          • Paul LE TURNIER, MD
        • Principal Investigator:
          • Paul LE TURNIER, MD
  • Reunion
      • Saint-Denis, Reunion
        • Active, not recruiting
        • Centre Hospitalier Universitaire de La Réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 informed consent form

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-vaccinated group
Patient who will not be vaccinated
Experimental: Vaccinated group
Patients who will be vaccinated with the IXCHIQ vaccine or the VIMKUNYA vaccine
Biological: IXCHIQ
Group of vaccinated arm will be with the IXCHIQ vaccine
Biological: VIMKUNYA
Other group of vaccinated arm will be with the VIMKUNYA vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Collaborators

Valneva Austria GmbH
Bavarian Nordic
ANRS, Emerging Infectious Diseases
Direction Générale de l'Offre de Soins
Région La Réunion
ARS La Réunion
ARS Guyane

Investigators

  • Study Director: Patrick GERARDIN, MD, CHU La Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/CHU/12
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521307-43-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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