VAC077: Safety and immunogenicity of the Pfs25-IMX313/Matrix-M vaccine
Research type
Research Study
Full title
A Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs25-IMX313 in Matrix-M1 adjuvant in healthy adults living in the UK
IRAS ID
261722
Contact name
Angela Minassian
Contact email
Eudract number
2019-000644-97
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Plasmodium falciparum malaria still exacts a huge burden of mortality and morbidity across some of the world's least developed regions. An effective vaccine would make a huge impact on the burden of disease and would accelerate progress towards elimination of malaria. A relatively new approach in malaria vaccine research is to design vaccines intended to block transmission of disease between individuals, rather than protect the vaccinated individual themselves.
This Phase 1a clinical trial is designed primarily to assess the safety and tolerability of the Pfs25-IMX313/Matrix-M transmission blocking vaccine in healthy adult volunteers. An important secondary objective is to to assess the immune reponse to the vaccine.
We will do this by giving participants three doses of the vaccine and taking blood samples for safety testing and to collect information about the immune response. We will also record any symptoms that occur after vaccination.
The Pfs25-IMX313 vaccine contains a protein which is found on the malaria parasite (plasmodium falciparum) so that the immune system builds a response to malaria. Matrix-M1 is a vaccine adjuvant which is added to the vaccine to produce a stronger immune response.
Healthy volunteers will be recruited in England at the Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford. Participants will be followed up for approximately eight months after vaccination.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0322
Date of REC Opinion
9 Aug 2019
REC opinion
Further Information Favourable Opinion