At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Plasmodium falciparum Malaria Protein 010 (FMP010) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
U.S. Army Medical Research and Development Command·interventional·Posted May 29, 2015·Updated Jun 28, 2023
In Brief
A Phase 1 clinical trial evaluating Plasmodium falciparum Malaria Protein 010 (FMP010) and Rabipur for Malaria. Completed, enrolled 30 participants.
Detailed 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.
Study Details
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
Primary CompletionDec 2008
Study CompletionJun 2009
First PostedMay 2015
TodayJul 2026
First PostedMay 29, 2015
Enrollment StartApr 1, 2008
Primary CompletionDec 1, 2008
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.1 years ago
Interventions
Plasmodium falciparum Malaria Protein 010 (FMP010)biological
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
Rabipurbiological
Rabipur is a licensed rabies vaccine.