Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana

Phase 4RecruitingNCT06928753

Centre Hospitalier Universitaire de la Réunion1,505 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

1,505

Conditions

Chikungunya Virus Infection

Interventions

IXCHIQBIOLOGICAL

Group of vaccinated arm will be with the IXCHIQ vaccine

VIMKUNYABIOLOGICAL

Other group of vaccinated arm will be with the VIMKUNYA vaccine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Centre Hospitalier Universitaire de Guyane

Cayenne, French Guiana

RECRUITING

Centre Hospitalier Universitaire de La Réunion

Saint-Denis, Reunion

ACTIVE_NOT_RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 6 months

Central 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

Data from ClinicalTrials.gov

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