RecruitingPhase 2NCT07675785

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

Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Immunogenicity, & Protective Efficacy of Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) in Healthy African Adult Women of Childbearing Potential in Mali


Sponsor

Sanaria Inc.

Enrollment

300 participants

Start Date

Jul 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 38 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Normal Saline and a biological treatment called PfSPZ-LARC2 Vaccine for people with malaria (plasmodium falciparum). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPfSPZ-LARC2 Vaccine

PfSPZ-LARC2 Vaccine (2x105 PfSPZ) via direct venous inoculation (DVI)

OTHERNormal Saline

Normal Saline


Locations(1)

University of Sciences, Techniques and Technology, Bamako (USTTB)

Bamako, Mali

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NCT07675785


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