Fast track development of a Zika vaccine based on measles vector.
The recent rapid spread of the Zika virus in previously unaffected regions has provided strong epidemiological evidence that infection with this virus might be associated with neurological complications in adults and with an increase in severe congenital brain and central nervous systems malformations of newborns. Consequently, in February 2016, the World Health Organization (WHO) has declared the recent outbreak of the Zika virus a Public Health Emergency of International Concern. In November 2016, WHO indicated that Zika virus and associated consequences remain a significant public health challenge requiring intense action.
The ZIKAVAX project aims at addressing this urgent public health issue by promoting the rapid development of a safe, effective, and affordable preventive vaccine against Zika virus infection. To achieve this goal, ZIKAVAX will use a delivery platform technology based on a measles vector (MV) with demonstrated proof of principle in humans and a preclinical track record of rapid adaptability and effectiveness for a variety of pathogens. In ZIKAVAX, following antigen selection and expression, immunisation studies will be conducted with the Zika vaccine candidate in mice and in a non-human primates challenge model that will be developed by the consortium. The ultimate goal of ZIKAVAX is the demonstration of safety and immunogenicity of a recombinant measles-Zika vaccine candidate (MV-ZIKA) in adult volunteers in a phase Ia clinical trial.
- To construct and characterise recombinant MV expressing Zika virus proteins as soluble secreted antigens
- To demonstrate preclinical immunogenicity and protective efficacy of the recombinant MV-Zika vaccine candidate(s) in a mouse model and in a non-human primate (NHP) model of Zika virus infection
- To manufacture a good manufacturing practice (GMP) clinical lot of the MV-Zika vaccine candidate using scalable platform technology
- To assess the safety and immunogenicity of the MV-Zika vaccine candidate in a phase I dose-escalation clinical trial
Work package components of ZIKAVAX and their timing during the four year project period.
- MV-ZIKA construct generated
- MV-ZIKA immunogenicity demonstrated in mice
- ZIKA infection challenge model in NHPs validated
- MV-ZIKA immunogenicity demonstrated in NHPs
- Process development for the MV-ZIKA vaccine candidate established
- Vaccine produced and released
- Toxicity studies in NHPs performed
- Phase Ia clinical trial completed
Participants at the ZIKAVAX Kick-off meeting, 25 November 2016, Frankfurt, Germany