About this trial
In the context of the ongoing chikungunya epidemic in Réunion Island and the anticipated epidemic in French Guiana, the investigators 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (Aged 18 or above)
Adult (Aged 18 or above) eligible for anti-chikungunya vaccination according to French High Health Authority (HAS)
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
IXCHIQ
Biological/VaccineGroup of vaccinated arm will be with the IXCHIQ vaccine
VIMKUNYA
Biological/VaccineOther group of vaccinated arm will be with the VIMKUNYA vaccine
Treatment groups
Trial 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
Sponsors and contacts
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Centre Hospitalier Universitaire de la Réunion
Lead sponsor
ANRS, Emerging Infectious Diseases
Collaborator
ARS La Réunion
Collaborator
Direction Générale de l'Offre de Soins
Collaborator
Valneva Austria GmbH
Collaborator
Bavarian Nordic
Collaborator
Agence Régionale de Santé Guyane
Collaborator
Région Réunion
Collaborator