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Last Updated: 04/05/2024
Safety and tolerability of bivalent malaria vaccine (JAIVAC-2: PfMSPFu24+PfF2/Alhydrogel) in healthy Indian adults
Objectives
The aim of this study is to assess the safety, tolerability and immunogenicity of Bivalent (JAIVAC-2) P. falciparum malaria vaccine consisting of two recombinant P. falciparum malaria antigens, PfMSPFu24 and PfF2 formulated with Alhydrogel adjuvant (PfMSPFu24+PfF2/Alhydrogel) in healthy malaria naïve Indian male adult subjects aged 18-45 years (both inclusive).
The study involves administration of investigational vaccine PfMSPFu24+PfF2/Alhydrogel in three dose-escalating cohorts corresponding to three dosages of 30, 45 and 75 µg (of each antigen, PfF2 and PfMSPFu24) with constant dosage of adjuvant Alhydrogel (850 µg).
The dose escalating design will allow study of safety (Immediate reactogenicity within the first hour after each Immunization, Solicited AEs occurring from one hour post Immunization till day 7, unsolicited AEs from one hour post Immunization till Day 28 days, SAE’s from the signing of ICD till the last follow-up visit and Laboratory safety during conduct of study) and immunogenicity of different doses of PfMSPFu24+PfF2/Alhydrogel.
The control vaccine to be used is Hepatitis B vaccine. In each cohort, 15 subjects will be enrolled. Following a 4:1 randomization scheme, twelve (12) subjects will receive the bivalent P. falciparum malaria vaccine while three (03) subjects will receive Hepatitis-B vaccine. Therefore, in total for this Phase I study forty-five (45) malaria naïve healthy male adults will be enrolled as subjects: thirty-six (36) subjects will receive the bivalent P. falciparum malaria vaccine (12 subjects in each cohort) and nine (09) subjects will receive Hepatitis B vaccine (03 subjects in each cohort).
Randomization and blinding will control for possible biases during study conduct. This study shall be completed when all the protocol defined visits and assessments are completed for all three Study cohorts. An independent Data Safety Monitoring Board (DSMB) will maintain a safety oversight for the study and will advise on dose escalation of bivalent P. falciparum malaria vaccine to the next higher dose cohort after reviewing the 7day safety data post first immunization for all 15 subjects of the previous cohort. Thus, enrolment for each new cohort shall have a delay of at least about 21 days from previous cohort to allow for safety data to be available & assessed by DSMB.
The volunteers will be enrolled at a single trial site (Human Pharmacology unit of Syngene International Limited, Bengaluru, India). The study population will include healthy Indian male subjects between 18 to 45 years of age (both inclusive). The subjects will be recruited from the healthy volunteer database of the study site. The recruitment in the study cohorts will begin sequentially but the study periods after initiation may overlap. Within each cohort, the study duration shall be divided into three periods: Screening period (21 days), immunization period (56 days), and Follow-up period (up to day 240).
Study type: Interventional
Enrollment: 45 participants
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking :Single (Participants)
Trial number: CTRI/2020/03/023739
Phase: Phase I