PfSPZ Vaccine in 1-12 year-old Gabonese children naturally exposed to malaria parasites

This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will be performed on 200 healthy Gabonese children, recruited across three age strata: 7-12, 3-6, and 1-2 years (12-35 months). Within each age stratum, volunteers will be randomized in a 2:1 ratio to receive three doses via direct venous inoculation (DVI) of either PfSPZ Vaccine (0.9×10^6) or normal saline (NS) on days 0, 7, and 28 respectively; a minimum of 40 and a maximum of 100 volunteers are included in each of these age-strata.
In total, approximately 133 children will receive the PfSPZ Vaccine and approximately 67 children will receive a placebo. Randomization will be stratified by age stratum, using permuted blocks of randomized size (3, 6, or 9). The start of inclusion into each age stratum will be staggered, such that immunization of the first 3-6-year-olds will not commence until two weeks after the start of immunization in the first 7-12-year-olds, and immunizations in the first 1-2-year-olds will not commence until two weeks after the start of immunization in the first 3-6-year-olds. All volunteers will receive presumptive treatment with artemether-lumefantrine two weeks prior to final immunization (day 14). All volunteers will receive presumptive treatment with an age-standardized 3-day course of oral artemether-lumefantrine (AL) ~two weeks prior to first immunization and again two weeks prior to final immunization.

Study type: Interventional
Enrollment: 200 participants
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
NCT number: NCT03521973
Phase: Phase II

Clinical trial registration

Vaccines (Immune Correlates)

Jun 2018 — Aug 2021

Gabon

Development of non-human primate models to assess immunological mechanisms and antigenic targets of protective sporozoite (SPZ) vaccines and establish superior efficacy of next generation SPZ vaccines