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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de la Réunion

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • IXCHIQ

    Biological/Vaccine

    Group of vaccinated arm will be with the IXCHIQ vaccine

  • VIMKUNYA

    Biological/Vaccine

    Other group of vaccinated arm will be with the VIMKUNYA vaccine

Treatment groups

1,505 Participants
are divided into 2 treatment groups
Group A: Vaccinated groupExperimental treatment 2 interventions
Group B: Non-vaccinated groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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