Accelerating Clinical Trials for CHIKungunya Vaccine in Africa
- Funded by European Commission
- Total publications:0 publications
Grant number: 101249063
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Key facts
Disease
ChikungunyaStart & end year
20262030Known Financial Commitments (USD)
$17,896,330.17Funder
European CommissionPrincipal Investigator
Anh WARTEL TResearch Location
FranceLead Research Institution
INSTITUT PASTEURResearch Priority Alignment
N/A
Research Category
Vaccines research, development and implementationResearch Subcategory
Phase 1 clinical trialSpecial Interest Tags
N/AStudy Type
ClinicalClinical Trial Details
Clinical Trial, Phase IBroad Policy Alignment
PendingAge Group
Adolescent (13 years to 17 years), Adults (18 and older), Children (1 year to 12 years)Vulnerable Population
UnspecifiedOccupations of Interest
Unspecified
Abstract
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.