Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children

NCT03521973 ↗

Phase 2 Completed 200 enrolled Sanaria Inc. Centre de Recherches Médicales de Lambaréné (CERMEL), German Center for Infection Research · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally exposed to malaria parasites. Healthy children aged 1- 12 years living in the surrounding areas of Lambaréné and/or Fougamou Province in Gabon will be eligible for participation.

Timeline

Start: 2018-06-14
Primary completion: 2021-05-18
Completion: 2021-08-03

Outcome

Missed primary endpoint

paper The age-stratum-adjusted vaccine efficacy (1 - hazard ratio) was 9% (95% CI -75 to 53; p=0·78). PMID 40972633 ↗

paper PfSPZ Vaccine is well tolerated and safe, but it did not prevent P falciparum infection in children in Gabon. PMID 40972633 ↗

Publications

Agnandji ST, Bok J, Alabi A, Kabwende AL, Mbouna A, Bie J, Moukiti E, Lalremruata A, Esen M, Kreidenweiss A, Kc N, Sim BKL, Richie TL, Preston Church LW, McCall MBB, Hoffman SL, Kremsner PG, Mordmuller B. Safety, tolerability, and protective efficacy of a radiation-attenuated, whole sporozoite malaria vaccine in children in Gabon: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2026 Jan;26(1):79-90. doi: 10.1016/S1473-3099(25)00434-7. Epub 2025 Sep 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PfSPZ Vaccine	Vaccine	900000 unknown	Other