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

C

Centre Hospitalier Universitaire de la Réunion

Status and phase

Enrolling
Phase 4

Conditions

Chikungunya Virus Infection

Treatments

Biological: IXCHIQ

Study type

Interventional

Funder types

Other

Identifiers

NCT06928753
2025/CHU/12
2025-521307-43-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment

1,800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,800 participants in 2 patient groups

Vaccinated group
Experimental group
Description:
Patients who will be vaccinated with the IXCHIQ vaccine
Treatment:
Biological: IXCHIQ
Non-vaccinated group
No Intervention group
Description:
Patient who will not be vaccinated

Trial contacts and locations

1

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Central trial contact

Patrick GERARDIN, MD; Laetitia Berly

Data sourced from clinicaltrials.gov

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