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;
Parallel
Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory
Biological/Vaccinelyophilized antigen for reconstitution with the adjuvant CTVad (a squalene-based nanoemulsion), at the time of use.
Placebo
Other interventionadjuvant CTVad (a squalene-based nanoemulsion)
Safety and reactogenicity of adverse events (AE) in the first 14 days
Frequency and intensity of solicited AEs with a possible causal relationship or higher up to 14 days after intramuscular administration of Vivaxin vaccine.
Safety and reactogenicity of EA in the first 28 days
Frequency and intensity of unsolicited AEs with a possible causal relationship or higher up to 28 days after intramuscular administration of Vivaxin vaccine.
Safety and reactogenicity of serious AEs (SAEs) and AEs of special interest (AESI) throughout the study duration
Frequency and intensity of SAEs and AESIs throughout the study duration after intramuscular administration of Vivaxin vaccine.
Dose selection
Selection of a safe and immunogenic dose of Vivaxin to continue clinical development.
Levels of IgG antibodies
Mean levels of IgG antibodies, calculated by the geometric mean of the titers against vaccine and parasitic antigens on days 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 in relation to time 0 and placebo, by ELISA.
Levels of IgM, IgG1, IgG2, IgG3, IgG4 and IgA against vaccine and parasitic antigens
1.Levels of IgM, IgG1, IgG2, IgG3, IgG4 and IgA against vaccine and parasitic antigens, such as the three variants of the Plasmodium vivax circumsporozoite protein (PvCSP), after intramuscular administration of the Vivaxin vaccine, in relation to time 0 and placebo, by ELISA.
Observe the multifunctional cellular immune response by evaluating the quality and frequency of CD4+ and CD8+ T lymphocytes in response to vaccine and parasite antigens
Frequency and quality of CD4+ and CD8+ T lymphocytes that produce multiple cytokines (such as IFNγ, IL-4/IL-13, IL-17, TNFa and IL-10) in response to vaccine and parasite antigens, on days 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 after intramuscular administration of the Vivaxin vaccine, in relation to time 0 and placebo, by ELISA
Levels of IFNγ and other cytokines
Levels of IFNγ and other cytokines (in pg/mL) produced by peripheral blood mononuclear cells (PBMC) in culture in response to vaccine and parasite antigens on days 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 after intramuscular administration of Vivaxin vaccine, in relation to time 0 and placebo, by ELISA.
Observe the genomic and transcriptomic diversity to better understand the immune response to the vaccine
Contribution of genomic and transcriptomic diversity to safety, reactogenicity and adverse event profile, as well as to the characterization of the humoral and cellular immune response.
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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
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