Real-world Effectiveness, Safety and Immunogenicity of Chikungunya Vaccination in Populations at Risk of Severe or Complicated Forms: Prospective Study in La Réunion (CHIK-RE-VAC)

July 28, 2025 updated by: Centre Hospitalier Universitaire de la Réunion
Against the backdrop of a growing chikungunya epidemic in La Réunion, this prospective study will assess the real-life efficacy, safety and immunogenicity of IXCHIQ® vaccine in vulnerable individuals (seniors, comorbid patients), defined by the French Health Autority (HAS) as at risk of severe or complicated forms and/or chronic disabling forms (chronic arthritis, chronic fatigue phenotypes). This study will also provide input for the preparation of a cluster randomized trial on a population scale.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1800

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

  • France
      • St Denis, France
        • Recruiting
        • CHU La Réunion
        • Principal Investigator:
          • Loic Raffray, MD, PhD
        • Contact:
        • Principal Investigator:
          • Patrick Gérardin, MD, PhD
        • Principal Investigator:
          • Ludovic Di Ascia, MD
        • Principal Investigator:
          • Barbara Kuli, MD
        • Principal Investigator:
          • Xavier Guillot, MD, PhD
        • Principal Investigator:
          • Emilie Mosnier, MD, PhD

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:

  • Eligible for anti-chikungunya vaccination according to french Health Authority (HAS)
  • Beneficiary of social security coverage
  • Signature of informed consent form

Exclusion Criteria:

  • Pregnant women
  • Vaccine 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

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
Experimental: Vaccinated group
Patients who will be vaccinated with the IXCHIQ vaccine
Biological: IXCHIQ
Group of vaccinated arm will be with the IXCHIQ vaccine
No Intervention: Non-vaccinated group
Patient who will not be vaccinated

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

ANRS, Emerging Infectious Diseases
Direction Générale de l'offre de Soins (DGOS)
Région La Réunion
ARS La Réunion

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)

April 1, 2026

Study Completion (Estimated)

October 1, 2026

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)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/CHU/12
  • 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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