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NCT Number: NCT06928753

Real-world Effectiveness, Safety and Immunogenicity of Chikungunya Vaccination in Populations at Risk of Severe or Complicated Forms: Prospective Study in 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.

Recruiting

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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

CHU La Réunion

Saint-Denis, France

Location status: Recruiting

Location contact

Barbara Kuli, MD

PRINCIPAL_INVESTIGATOR

Emilie Mosnier, MD, PhD

PRINCIPAL_INVESTIGATOR

Loic Raffray, MD, PhD

PRINCIPAL_INVESTIGATOR

Ludovic Di Ascia, MD

PRINCIPAL_INVESTIGATOR

Patrick GERARDIN, MD

CONTACT

[email protected]

(262) 2 62 35 9435

Patrick Gérardin, MD, PhD

PRINCIPAL_INVESTIGATOR

Xavier Guillot, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

IXCHIQ

Biological

Group of vaccinated arm will be with the IXCHIQ 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 La Réunion
  • Direction Générale de l'Offre de Soins
  • Région La Réunion

Registry information

Acronym: CHIK-RE-VAC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Jul 29, 2025

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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