About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eligible for anti-chikungunya vaccination according to french Health Authority (HAS)
Beneficiary of social security coverage
Signature of informed consent form
Disqualifiers
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
Parallel
Treatments tested in this trial
IXCHIQ
Biological/VaccineGroup of vaccinated arm will be with the IXCHIQ 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
Région La Réunion
Collaborator
ARS La Réunion
Collaborator
Direction Générale de l'Offre de Soins
Collaborator