Phase 1 of PfSPZ Vaccine in healthy, malaria-naïve, adults, heterologous CHMI

This is a randomized, double-blind, placebo-controlled, single site, trial of a condensed regimen of PfSPZ vaccine administered on Days 1, 8, and 29 by direct venous inoculation (DVI). The trial is designed to simulate the pre-deployment immunization of military personnel. Prior studies with this regimen show high level protection (>80%) against CHMI at 21 days, but the onset and duration of protection have not been fully defined.

Study type: Interventional
Enrollment: 54 participants
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
NCT number: NCT04966871
Phase: Phase I

Clinical trial registration

Vaccines (Immune Correlates)

Sep 2021 — Jun 2022

United States

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