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NCT Number: NCT06928753

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

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Key information

Conditions

Chikungunya Virus Infection Alphavirus Infections Arbovirus Infections Chikungunya Fever Infections Mosquito-Borne Diseases RNA Virus Infections Togaviridae Infections Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Universitaire de Guyane, Cayenne, French Guiana

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IXCHIQ

Biological

Group of vaccinated arm will be with the IXCHIQ vaccine

VIMKUNYA

Biological

Other group of vaccinated arm will be with the VIMKUNYA vaccine

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Florence LEFEBVRE D'HELLENCOURT

CONTACT

[email protected]

+262 262 75 34 71

Patrick GERARDIN, MD

CONTACT

[email protected]

(262) 2 62 35 9435

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Collaborators

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

Registry information

Official study title

Real-world Effectiveness, Safety, and Immunogenicity of Chikungunya Vaccination During an Epidemic Period: an Ambispective Study in Réunion Island and French Guiana.

Acronym: CHIK-RE-VAC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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