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)

Centre Hospitalier Universitaire de la Réunion

Status and phase: Enrolling; Phase 4

Conditions: Chikungunya Virus Infection

Treatments: Biological: IXCHIQ

Study type: Interventional

Funder types: Other

Identifiers

NCT06928753

2025/CHU/12

2025-521307-43-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,800 participants in 2 patient groups

Vaccinated group

Experimental group

Description:

Patients who will be vaccinated with the IXCHIQ vaccine

Treatment:

Biological: IXCHIQ

Non-vaccinated group

No Intervention group

Description:

Patient who will not be vaccinated