Real-world Effectiveness, Safety and Immunogenicity of Chikungunya Vaccination in Populations at Risk of Severe or Complicated Forms: Prospective Study in La Réunion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IXCHIQ.
- Who it may be relevant to
- Registry conditions: Chikungunya Virus Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Biological IXCHIQ
Group of vaccinated arm will be with the IXCHIQ vaccine
Primary outcome measures
- To measure the vaccine effectiveness at 6 months [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU La Réunion — Saint-Denis
Identifiers
NCT: NCT06928753 · 2025/CHU/12 · 2025-521307-43-00