Assessing the effectiveness and safety of a chikungunya vaccine in at-risk populations
Real-world Effectiveness, Safety and Immunogenicity of Chikungunya Vaccination in Populations at Risk of Severe or Complicated Forms: Prospective Study in La Réunion
This study is testing a chikungunya vaccine to see if it helps protect seniors and people with other health issues during an outbreak.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de la Réunion Academic / other |
| Locations | 1 site (Saint-Denis) |
| Trial ID | NCT06928753 on ClinicalTrials.gov |
What this trial studies
This prospective study evaluates the real-world efficacy, safety, and immunogenicity of the IXCHIQ® vaccine in vulnerable individuals, such as seniors and patients with comorbidities, during a chikungunya epidemic in La Réunion. The study aims to gather data that will inform a larger cluster randomized trial on a population scale. Participants will be monitored for adverse effects and immune response to the vaccine, contributing to the understanding of its effectiveness in preventing severe forms of chikungunya virus infection.
Who should consider this trial
Good fit: Ideal candidates for this study include seniors and individuals with comorbid conditions who are eligible for anti-chikungunya vaccination as defined by the French Health Authority.
Not a fit: Patients who are pregnant, have contraindications to vaccination, or have received immunoglobulin or blood products within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the effectiveness of the chikungunya vaccine, potentially reducing the incidence of severe disease in at-risk populations.
How similar studies have performed: While this study focuses on a specific population and context, similar studies on vaccine effectiveness in at-risk groups have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saint-Denis
- CHU La Réunion — Saint-Denis, France (Recruiting)
Study contacts
- Study coordinator: Patrick GERARDIN, MD
- Email: patrick.gerardin@chu-reunion.fr
- Phone: (262) 2 62 35 9435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.