At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 40 enrolled

Drug / intervention

FMP1/AS02A +1 morebiological

Likely dose

FMP1/AS02A 0.5 mLfrom 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.

Search/NCT00308061

NCT00308061Phase 1Completed

Compare CT.gov

Double Blind Randomized Controlled Phase I Trial to Evaluate the Safety and Immunogenicity of WRAIR's MSP1 Candidate Malaria Vaccine (FMP1) Adjuvant in GSK Bio's AS02A vs. Rabies Vaccine in Semi-immune Adults in Bandiagara, Mali.

U.S. Army Medical Research and Development Command·interventional·Posted Mar 28, 2006·Updated Jul 31, 2017

In Brief

A Phase 1 clinical trial evaluating FMP1/AS02A and Imovax Rabies Vaccine for Malaria. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This study tested the safety of a new malaria vaccine in adults in Mali, West Africa, and measured the ability of the vaccine to stimulate antibodies directed against the malaria protein that the vaccine is based on. Forty adults were randomly assigned to get either the experimental malaria vaccine or a rabies vaccine, for comparison.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMalaria

CountriesMali

CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), Walter Reed Army Institute of Research (WRAIR), GlaxoSmithKline, United States Agency for International Development (USAID)

Timeline

Phase 1CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2003

Primary CompletionSep 2004

Study CompletionJul 2005

First PostedMar 2006

TodayJul 2026

First PostedMar 28, 2006

Enrollment StartJul 1, 2003

Primary CompletionSep 1, 2004

Study CompletionJul 1, 2005

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 20.3 years ago

Interventions

FMP1/AS02Abiological

FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.

Imovax Rabies Vaccinebiological

Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, \<150g of neomycin sulfate, and \>2.5 IU of rabies antigen.