CHIKUNGUNYA VIRUS, STRAIN CHIKV LR2006-OPY1, LIVE ATTENUATED for Chikungunya

Inclusion criteria

• {"criterion_text":"- For both studies, Signature of informed consent form\n- For both studies, Eligible for anti-chikungunya vaccination according to HAS recommendations\n- For boths studies, Beneficiary of social security coverage\n- For both studies, Agreeing to participate in the study - Adults (≥18 years and under 65)\n- For the Retrospective study, adults 18 years and above already vaccinated\n- For the Prospective study, adults aged 18-64"}

Exclusion criteria

• {"criterion_text":"- Pregnant women\n- Vaccine contraindication for patients undergoing medical treatment (e.g. following hematological cancer or solid tumor, administration of chemotherapy, congenital immunodeficiency or long-term immunosuppressive therapy, or severely immunosuppressed HIV-infected patients)\n- Persons under guardianship, curatorship or safeguard of justice\n- Anyone who has received immunoglobulin or a blood or plasma transfusion 3 months prior to vaccine administration.\n- Not beneficiary of Social Security Coverage"}

Primary endpoints

• {"endpoint_text":"- EV defined as the quotient of the difference in attack rate between unvaccinated and vaccinated participants divided by the attack rate in unvaccinated participants: EV (%): (λnv - λv) × 100 / λnv The attack rate (λ) corresponds to the cumulative incidence (%) at the end of the study follow-up period (interim analysis at 3 months at the end of the hot season, then at the end of full follow-up at 12 months) from D7 post-vaccination for the vaccinated group.","definition_or_measurement_approach":"EV calculated as (λnv - λv) × 100 / λnv where λ = cumulative incidence (%) at end of follow-up. Measurement timings: interim analysis at 3 months (end of hot season) and full follow-up at 12 months; for vaccinated group follow-up counted from D7 post-vaccination."}

Secondary endpoints

• {"endpoint_text":"- Rate of hospitalization over 24 hours and preventive fraction of hospitalization in vaccinated and unvaccinated participants","definition_or_measurement_approach":"Rate of hospitalisation >24 hours in vaccinated vs unvaccinated and corresponding preventive fraction measured at J30 and M12 (per endpoint translations)."}
• {"endpoint_text":"- Rate of ICU hospitalization or death and preventive fraction in vaccinated and unvaccinated participants at D30 and at the end of the study","definition_or_measurement_approach":"Rate of ICU admission or death in vaccinated vs unvaccinated with preventive fraction computed; assessed at D30 and at study end (M12)."}
• {"endpoint_text":"- Rate of disabling complications such as arthralgia and/or chronic phenotypes (fatigue/anxiety-depression) at 3 months of inclusion, and at the end of the study.","definition_or_measurement_approach":"Occurrence rate of disabling complications (e.g., arthralgia, chronic phenotypes such as fatigue/anxiety-depression) measured at 3 months and at 12 months (end of study)."}

Methods

• Vaccination offered to people corresponding to profiles of vulnerable persons according to HAS recommendations in La Réunion (France); recruitment via participating healthcare sites (hospitals, clinics, general medical practices) listed in the trial site list, targeting populations at risk of severe or complicated forms of chikungunya.

France

Earliest CTIS Part Ii Submission Date

01-04-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

202

Number Of Sites

17

Number Of Participants

1800

Primary sponsor

Full Name

Centre Hospitalier Universitaire De La Reunion

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"ANRS-MIE","duties_or_roles":"","organisation_type":""}
• {"country":"","full_name":"Région Réunion","duties_or_roles":"","organisation_type":""}
• {"country":"","full_name":"ARS La Réunion","duties_or_roles":"","organisation_type":""}