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Accelerating Clinical Trials for CHIKungunya Vaccine in Africa

Project description

Evaluating a candidate chikungunya vaccine in Africa

The measles-vectored virus chikungunya (MV-CHIK) vaccine, developed by the Institut Pasteur, is a live attenuated recombinant vaccine that induces neutralising antibodies against chikungunya. Clinical trials have shown satisfactory safety and immunogenicity profiles. The EU-funded ACT-CHIK project will promote the clinical evaluation of the MV-CHIK candidate vaccine through a phase Ib/III study involving adults, adolescents and children in both non-endemic and endemic African countries. This study will confirm the vaccine’s safety and immunogenicity profiles. The consortium will generate clinical data and introduce a new measles virus vaccine platform in Africa to enhance pandemic preparedness and outbreak control. The vaccine has substantial potential to improve public health by combatting chikungunya and related diseases in Africa.

Objective

The Measles-virus chikungunya (MV-CHIK) vaccine is a live-attenuated, recombinant, measles-vectored vaccine developed from the Schwarz vaccine strain of the measles virus (MV) by the Institut Pasteur in Paris. The immunogenicity and protective efficacy of MVCHIK have been substantiated through studies conducted on a mouse model susceptible to the measles virus and in non-human primates, specifically adult cynomolgus macaques. This evidence indicates that the neutralising antibodies elicited by the vaccine, with a titer of 5 x 10^5 ± 0.5 log TCID50, confer protection against lethal challenges posed by chikungunya and related diseases. Six Phase I and II clinical trials have been conducted, positioning the product for progression to further clinical assessments, with Phase 3 clinical trial material. In these preliminary safety, dose-finding, and immunogenicity investigations, 639 subjects received varied doses of the candidate vaccine across both endemic and non-endemic regions, and the results indicate satisfactory safety, tolerability, and immunogenicity profiles. Derived from encouraging preclinical and Phase I–II clinical data, this grant proposal advocates for the
clinical evaluation of the MV-CHIK candidate vaccine through a Phase Ib/III study involving adults, adolescents, and children residing in both non-endemic and endemic African countries to confirm the satisfactory safety and immunogenicity profiles of the MV-CHIK vaccine. The consortium will facilitate the generation of evidence-based clinical data and introduce an innovative MV vaccine platform to Africa for enhanced pandemic preparedness and outbreak control. Comprehensive due diligence and gap analysis will be executed to pinpoint a manufacturing partner before implementing the technology transfer plan. The prospective impact of this vaccine on public health is considerable, offering a promising solution in the battle against chikungunya and associated diseases in Africa.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

(opens in new window) HORIZON-JU-GH-EDCTP3-2025-01-two-stage

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Coordinator

INSTITUT PASTEUR
Net EU contribution
€ 1 297 736,25
Address
RUE DU DOCTEUR ROUX 25-28
75724 Paris
France
Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Links
Total cost
€ 1 297 736,25

Participants (7)