PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali
brief 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).
detailed description
This study will enroll healthy Malian adult, non-pregnant WOCBP, who agree to be on birth control during the immunization period, between 18 and 38 years of age to participate in a randomized, double blind, placebo-controlled study to assess the safety, immunogenicity and protective efficacy of PfSPZ-LARC2 Vaccine during two years' of follow up, including at least two malaria transmission seasons. Participants will be immunized with a 3-dose series of 2x10\^5 PfSPZ of PfSPZ-LARC2 Vaccine or normal saline (NS); placebo) at 1, 6, 29 days. Vaccinated subjects and controls will then be assessed for malaria infection during the ensuing two malaria transmission seasons and subsequent dry seasons, including following prospectively women who become pregnant during follow up and their offspring. Volunteers will be randomized into two arms at a 1:1 ratio to receive PfSPZ-LARC2 Vaccine (N=150) versus NS control (N=150).
If a woman becomes pregnant during follow-up, she will continue to be followed through the course of her pregnancy and for at least one year after delivery. Subsequent offspring born from pregnancies from this time period will also be followed for one year post birth.
Two study arms will be enrolled in this study, with two PfSPZ-LARC2 vaccination arms and one NS control arm.
Arm 1: (N=150) will receive 3 doses of PfSPZ-LARC2 Vaccine (2x10\^5) via direct venous inoculation (DVI) at 1, 6, 29 days.
Arm 2: (N=150) will receive 3 doses of placebo NS injection via DVI at 1, 6, 29 days.
All injections will be administered by DVI. All participants will receive antimalarial treatment with artemether/lumefantrine (AL) approximately 2-4 weeks prior to the 1st and 3rd injections. Post 3rd injection, participants will be followed through the malaria transmission (rainy) season, approximately 6 months, and then the ensuing dry season for an additional 6 months. Participants will be monitored for safety, immunogenicity, and protective efficacy (malaria infection) during the follow-up period.
During the second year of follow-up, which will start immediately at the conclusion of the first year of follow-up, participants will be followed through the malaria transmission (rainy) season, approximately 6 months, and then the second dry season for an additional 6 months. Participants will be monitored for safety (unsolicited AEs), immunogenicity, and protective efficacy (malaria infection) during the second year of follow-up. No vaccine boost is planned at the end of the first year.
official title
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