NCT02458092

Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B

Phase 1b Controlled Double Blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Candidate Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered Intramuscularly With Glaxo Smith Kline (GSK) Biologicals' Adjuvant AS01B

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.

Detailed description

Study is to evaluate the safety, reactogenicity, and immunogenicity fo the candidate Plasmodium falciparum malaria protein 10 (FMP010). Malaria-experienced adults will be enrolled and randomized into 2 groups. Subjects will receive full dose FMP010 antigen (approximately 50 μg) in 0.5 mL AS01B adjuvant or licensed rabies vaccine Rabipur (by Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent (sterile water) for injection.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	Plasmodium falciparum Malaria Protein 010 (FMP010)	Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK
BIOLOGICAL	Rabipur	Rabipur is a licensed rabies vaccine.

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-12-01
• Completion: 2009-06-01
• First posted: 2015-05-29
• Last updated: 2023-06-28
• Results posted: 2020-06-09