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

Real-world Effectiveness, Safety, and Immunogenicity of Chikungunya Vaccination During an Epidemic Period: an Ambispective Study in Réunion Island and French Guiana.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06928753
Acronym
CHIK-RE-VAC
Enrollment
1505
Registered
2025-04-15
Start date
2025-04-18
Completion date
2027-12-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chikungunya Virus Infection

Keywords

Prophylaxis, Safety, Efficacy, Vaccine effectiveness, Chikungunya

Brief summary

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).

Interventions

BIOLOGICALIXCHIQ

Group of vaccinated arm will be with the IXCHIQ vaccine

BIOLOGICALVIMKUNYA

Other group of vaccinated arm will be with the VIMKUNYA vaccine

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER
ANRS, Emerging Infectious Diseases
CollaboratorOTHER_GOV
Région La Réunion
CollaboratorUNKNOWN
ARS La Réunion
CollaboratorUNKNOWN
Direction Générale de l'Offre de Soins
CollaboratorOTHER_GOV
ARS Guyane
CollaboratorUNKNOWN
Valneva Austria GmbH
CollaboratorINDUSTRY
Bavarian Nordic
CollaboratorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To measure the vaccine effectiveness at 6 months6 monthsVaccine effectiveness defined at 6 months as the difference in attack rate between unvaccinated and vaccinated participants divided by the attack rate in unvaccinated participants

Countries

French Guiana, Reunion

Contacts

CONTACTPatrick GERARDIN, MD
patrick.gerardin@chu-reunion.fr(262) 2 62 35 9435
CONTACTFlorence LEFEBVRE D'HELLENCOURT
promotion.drci@chu-reunion.fr+262 262 75 34 71
STUDY_DIRECTORPatrick GERARDIN, MD

CHU La Réunion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026