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

Phase 4

Recruiting

• Conditions: Chikungunya Virus Infection
• Interventions: Biological: IXCHIQ

• Registration Number: NCT06928753
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Study First Posted: 2025-04-15
• Study Start: 2025-04-18
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-04
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaccinated group	IXCHIQ	Patients who will be vaccinated with the IXCHIQ vaccine

Primary Outcome Measures

Name	Time	Method
To measure the vaccine effectiveness at 6 months	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

Trial Locations

Locations (1)

CHU La Réunion; 🇫🇷 St Denis, France