Phase 1 clinical trial to evaluate the safety, reactogenicity, and immunogenicity of a malaria vaccine named Vivaxin against the protozoan Plamodium vivax in participants with no prior malaria infection
Non-pregnant women and men aged between 18 and 59 years;
Willingness to participate in the study and undergo all study procedures, as demonstrated by signing the informed consent form (ICF);
In good general health, as determined by medical examination;
Women of childbearing potential must agree to use an acceptable* contraceptive method for at least 30 days prior to the first vaccination and for at least 6 months following administration of the first dose of the investigational product, ensuring at least 3 months after the final vaccine dose have elapsed;
Prior history of malaria infection confirmed by serological testing;
Prior history of malaria vaccination;
Intention to travel to a malaria-endemic area during the study period;
Pregnant or breastfeeding women, or those intending to become pregnant or breastfeed within the first 6 months of the study;
Federal University of Minas Gerais
Lead sponsor
University of Sao Paulo
Collaborator
Financiadora de Estudos e Projetos
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator
INCTV National Institute of Vaccine Science and Technology
Collaborator
The Ministry of Science, Technology and Innovation, Brazil
Collaborator
CT Vacinas - Centro de Tecnologia em Vacinas/Universidade Federal de Minas Gerais
Collaborator