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

NCT06928753 | Recruiting Phase 4

• 2 other identifiers: 2025/CHU/122025-521307-43-00
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chikungunya Virus Infection

Keywords

Prophylaxis, Safety, Efficacy, Vaccine effectiveness, Chikungunya

Outcome Measures

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

  6 months

Study Arms (2)

Vaccinated group

EXPERIMENTAL

Patients who will be vaccinated with the IXCHIQ vaccine

Biological: IXCHIQ

Non-vaccinated group

NO INTERVENTION

Patient who will not be vaccinated

Interventions

IXCHIQ BIOLOGICAL

Group of vaccinated arm will be with the IXCHIQ vaccine

Vaccinated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead
• ANRS, Emerging Infectious Diseases: collaborator
• Région La Réunion: collaborator
• ARS La Réunion: collaborator
• Direction Générale de l'offre de Soins (DGOS): collaborator

Study Sites (1)

CHU La Réunion

Saint-Denis, France

RECRUITING

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Study Officials

• Patrick GERARDIN, MD

  CHU La Réunion

  STUDY DIRECTOR

Central Study Contacts

Patrick GERARDIN, MD

CONTACT

(262) 2 62 35 9435; patrick.gerardin@chu-reunion.fr

Florence LEFEBVRE D'HELLENCOURT

CONTACT

+262 262 75 34 71; promotion.drci@chu-reunion.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 15, 2025
• Study Start: April 18, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-04

Locations

FR (1)