Evaluation of the real-life efficacy, safety, and immunogenicity of chikungunya vaccination in populations at risk of severe or complicated disease: an ambispective study in La Réunion

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De La Reunion

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

18 Apr 2025 → ongoing

Decision date (initial)

2025-04-04

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

ARS La Réunion · Région Réunion · ANRS-MIE

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis, Safety

To measure the vaccine effectiveness at 6 months (EV) of the chikungunya vaccine on the occurrence of confirmed chikungunya (PCR+ or IgM+ in a participant not previously immunized during the epidemic phase in vulnerable populations.

Secondary objectives 3

1. To measure the EV in preventing hospitalization of more than 24 hours in vaccinated patients
2. To measure the EV in preventing intensive care unit (ICU) hospitalization or death in vaccinated participants
3. To measure the EV to prevent disabling complications

Conditions and MedDRA coding

Infectious disease: Chikungunya

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. For both studies, Signature of informed consent form
2. For both studies, Eligible for anti-chikungunya vaccination according to HAS recommendations
3. For boths studies, Beneficiary of social security coverage
4. For both studies, Agreeing to participate in the study - Adults (≥18 years and under 65)
5. For the Retrospective study, adults 18 years and above already vaccinated
6. For the Prospective study, adults aged 18-64

Exclusion criteria 5

1. Pregnant women
2. Vaccine contraindication for patients undergoing medical treatment (e.g. following hematological cancer or solid tumor, administration of chemotherapy, congenital immunodeficiency or long-term immunosuppressive therapy, or severely immunosuppressed HIV-infected patients)
3. Persons under guardianship, curatorship or safeguard of justice
4. Anyone who has received immunoglobulin or a blood or plasma transfusion 3 months prior to vaccine administration.
5. Not beneficiary of Social Security Coverage

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. EV defined as the quotient of the difference in attack rate between unvaccinated and vaccinated participants divided by the attack rate in unvaccinated participants: EV (%): (λnv - λv) × 100 / λnv The attack rate (λ) corresponds to the cumulative incidence (%) at the end of the study follow-up period (interim analysis at 3 months at the end of the hot season, then at the end of full follow-up at 12 months) from D7 post-vaccination for the vaccinated group.

Secondary endpoints 3

1. Rate of hospitalization over 24 hours and preventive fraction of hospitalization in vaccinated and unvaccinated participants
2. Rate of ICU hospitalization or death and preventive fraction in vaccinated and unvaccinated participants at D30 and at the end of the study
3. Rate of disabling complications such as arthralgia and/or chronic phenotypes (fatigue/anxiety-depression) at 3 months of inclusion, and at the end of the study.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De La Reunion

Sponsor organisation

Centre Hospitalier Universitaire De La Reunion

Address

Allee Des Topazes, Cs 11021 Cs 11021

City

St Denis

Postcode

97400

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De La Reunion

Contact name

Florence Lefebvre dhellencourt

Public contact point

Organisation

Centre Hospitalier Universitaire De La Reunion

Contact name

Florence Lefebvre dhellencourt

Locations

2 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications