Work Package 4 (WP4): MV-CHIK Vaccine Manufacturing and Clinical Assays
Work Package 4 (WP4) is responsible for ensuring the reliable manufacture of the MV-CHIK vaccine and the laboratory testing required to support the ACT-CHIK clinical trials. The work package focuses on producing high-quality clinical trial materials, strengthening vaccine manufacturing capacity, and conducting laboratory analyses that measure the immune responses generated by the vaccine.
By integrating vaccine production with advanced clinical laboratory assays, WP4 plays a critical role in ensuring that the vaccine evaluated in the clinical trials meets international quality standards while generating robust scientific evidence on its safety and immunogenicity.
Vaccine Manufacturing
WP4 supports the production of the MV-CHIK vaccine using internationally recognized manufacturing standards to ensure that every vaccine batch used in the clinical trial is safe, consistent, and of high quality.
The work package also contributes to strengthening regional vaccine manufacturing capacity by supporting technology transfer and production scale-up within Africa.
Clinical Assays
Clinical assays are essential for determining how well the vaccine stimulates the body’s immune system.
WP4 performs specialized laboratory analyses to:
- Measure neutralizing antibodies against the chikungunya virus.
- Assess vaccine-induced immune responses.
- Evaluate the quality and consistency of laboratory data.
- Support immunogenicity analyses across participating clinical trial sites.
- Generate laboratory evidence to complement clinical safety findings.
These laboratory results are fundamental in determining whether the vaccine provides a strong and durable immune response.
Objectives
1. Work with Fiocruz for the supply of the clinical trial materials necessary for the African phase Ib/III study
2. Due diligence, gap analysis, and development of a detailed plan for scaling up and implementing the commercial production of the MV-CHIK in both IPD and Fiocruz, including the process development in the pilot cGMP facility operational in Fiocruz
3. Clinical sample testing at IPD
Work Package Lead Beneficiary : Institut Pasteur de Dakar (IPD)
Work Package Participants : Institut Pasteur (IP),Fundação Oswaldo Cruz (Fiocruz),Foundation for Scientific and Technological Development in Health (Fiotec), International Vaccine Institute (IVI)