Initiation date: 2006
End date: 2007
Past project identifier: NCT00312663
Partner trial identifier: WRAIR1250
Official title: A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS01B Candidate Malaria Vaccine in Malaria-naive Adults Living in the United States
Project description: Phase 1/2 trial of the FMP011/AS01B malaria vaccine candidate in adults living in the United States*

This Phase 1/2 study, conducted in malaria-naïve adults in the United States, was designed to determine the safety, immunogenicity, and initial efficacy of the recombinant liver-stage antigen-1 (LSA1) vaccine candidate—also referred to as falciparum malaria protein-11 (FMP011)—when adjuvanted in GlaxoSmithKline’s (GSK) AS01B.

Volunteers were randomized into two dose-escalating groups (10 µg and 50 µg), and received multiple intramuscular vaccinations of LSA1 adjuvanted with 0.5 mL AS01B on a 0,1-month schedule.

The study was designed with two objectives:

  1. Assess the safety and reactogenicity of LSA1/ AS01B in malaria-naïve adults by monitoring for occurrence of solicited signs and symptoms, occurrence of unsolicited symptoms, and the occurrence of serious adverse events during the study period.

  2. Assess the efficacy of the candidate vaccine against sporozoite challenge with Plasmodium falciparum, and assess cell-mediated immune response.

Enrollment: 36

Outcomes/Next steps: Findings were published in Vaccine in 2010, and presented in part at the American Society of Tropical Medicine and Hygiene Annual Meeting in 2006.

LSA1/AS01B was found to be well-tolerated, with low systemic reactogenicity in subjects. Despite its immunogenicity, LSA1/AS01B did not offer efficacy against Plasmodium falciparum.

Based on the outcomes of this study, the PATH Malaria Vaccine Initiative did not make further investments.

View detailed study record on

Related resources:
Cummings JF, Spring MD, Schwenk RJ, Ockenhouse CF, Kester KE, et al. Recombinant liver stage antigen-1 (LSA-1) formulated with AS01 or AS02 is safe, elicits high titer antibody and induces IFN-γ/IL-2 CD4+ T cells but does not protect against experimental Plasmodium falciparum infection. Vaccine. 2010;28(31):5135-5144.

*Source:; date accessed January 24, 2018.