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

Phase 4RecruitingNCT06928753

Centre Hospitalier Universitaire de la Réunion1,800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

1,800

Conditions

Chikungunya Virus Infection

Interventions

IXCHIQ

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Eligible for anti-chikungunya vaccination according to french Health Authority (HAS) * Beneficiary of social security coverage * Signature of informed consent form Exclusion Criteria: * 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

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

Time frame: 6 months