Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults

Summary

Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for protecting troops against malaria are insecticidal nets, clothing, and antimalarial treatment. To be effective, these methods must be self-administered and be used consistently, often unattainable in field or combat situations. The United States Army Medical Research and Development Command (USAMRMC), through the United States Army Medical Materiel Development Activity (USAMMDA) and the Walter Reed Army Institute of Research (WRAIR) are actively pursuing the development of an effective vaccine against P. falciparum malaria; development of such a vaccine is a high priority for the US military and other individuals who travel to endemic regions, and is equally important to populations residing in those areas.

A Phase 1 study using FMP012, a recombinant E.coli expressed malaria protein (CelTOS) vaccine will

1. assess the safety and reactogenicity of candidate P. falciparum malaria vaccine FMP012/GLA-SE

Secondary:
2. measure the humoral immune response to FMP012/GLA-SE using enzyme-linked immunosorbent assay (ELISA)
3. assess the protective efficacy of FMP012/GLA-SE against a P. falciparum sporozoite challenge.

Conditions

• Malaria

Interventions

BIOLOGICAL

Group 1: 10 ug FMP012 with 2 ug GLA-SE

Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant

BIOLOGICAL

Group 2: 10 ug FMP012 with 5 ug GLA-SE

E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant

BIOLOGICAL

50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE

E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant

OTHER

Controlled group-Challenged Only: no vaccination

The control group participated in the primary malaria sporozoite challenge.E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant

Sponsors & Collaborators

• United States Agency for International Development (USAID)

  collaborator FED

• Access to Advanced Health Institute (AAHI)

  collaborator OTHER

• U.S. Army Medical Research and Development Command

  lead FED

Principal Investigators

• Jessica J. Cowden, MD · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2012-10-31

Completion

2012-12-31

Countries

• United States

Study Locations