Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana (CHIK-RE-VAC)

Centre Hospitalier Universitaire de la Réunion

Status and phase: Enrolling; Phase 4

Conditions: Chikungunya Virus Infection

Treatments: Biological: VIMKUNYA; Biological: IXCHIQ

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06928753

2025/CHU/12

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

2025

Details and patient eligibility

About

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).

Enrollment: 1,505 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,505 participants in 2 patient groups

Vaccinated group

Experimental group

Description:

Patients who will be vaccinated with the IXCHIQ vaccine or the VIMKUNYA vaccine

Treatment:

Biological: IXCHIQ

Biological: VIMKUNYA

Non-vaccinated group

No Intervention group

Description:

Patient who will not be vaccinated