Real-world Effectiveness, Safety and Immunogenicity of Chikungunya Vaccination in Populations at Risk of Severe or Complicated Forms: Prospective Study in La Réunion

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

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • IXCHIQ

    Biological/Vaccine

    Group of vaccinated arm will be with the IXCHIQ vaccine

Treatment groups

1,800 Participants
are divided into 2 treatment groups
Group A: Vaccinated groupExperimental treatment 1 intervention
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

Région La Réunion

Collaborator

ARS La Réunion

Collaborator

Direction Générale de l'Offre de Soins

Collaborator