PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali

A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity, and protective efficacy of 1, 6, 29-day PfSPZ-LARC2 Vaccine regimen given at a dose of 2 x10\^5 PfSPZ or placebo in healthy WOCBP, who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future. Participants will be randomized into two arms. Arm 1: (n= 150) will receive 3 doses of PfSPZ-LARC2 Vaccine (2x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 6, 29 days. Arm 2: (n= 150) will receive 3 doses of normal saline (placebo) injection via DVI at 1, 6, 29 days. All volunteers will receive antimalarial treatment with artemether/lumefantrine (AL) \~2 to 4 weeks prior to 1st (study day -14 to -28) and \~2 weeks prior to 3rd injection (study day 44). Participants will be monitored for safety, tolerability, immunogenicity, and malaria infection during the follow-up period. Participants will also be monitored closely for pregnancy as well post 3rd injection through the entire planned study duration (2 years post dose 1). If pregnant, women will be followed during the course of their pregnancy and for at least 1 year post-delivery (as well as their offspring) for safety and malaria infection. Malaria infections in participants and their offspring will be classified as asymptomatic or symptomatic (clinical cases).

NCT Number	NCT07675785
Lead Sponsor	Sanaria Inc. Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), University of the Sciences, Techniques and Technologies of Bamako, Malaria Research and Training Center, Bamako, Mali
Conditions	Malaria (Plasmodium Falciparum)
Enrollment	300 participants
Start Date	2026-07-20
Primary Completion	2028-07-15 (estimated)
Study Completion	2030-04 (estimated)
Updated on ClinicalTrials.gov	2026-07-23