CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
VMP001 +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.

Search/NCT01157897
NCT01157897Phase 2Completed
CompareCT.gov

Phase 1/2a Open-label Dose Safety, Reactogenicity, Immunogenicity and Efficacy of the Candidate Plasmodium Vivax Malaria Protein 001 (VMP001) Administered Intramuscularly With GlaxoSmithKline (GSK) Biologicals' Adjuvant System AS01B in Healthy Malaria-Naïve Adults

U.S. Army Medical Research and Development Command·interventional·Posted Jul 7, 2010·Updated May 29, 2019

In Brief

A Phase 2 clinical trial evaluating VMP001 and P. vivax sporozoite challenge for Malaria and Plasmodium Vivax. Completed, enrolled 41 participants across 1 site.

Detailed Summary

This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open label study will be performed in malaria-naïve adults in the United States. Three doses of VMP001 formulated in AS01B (adjuvant system) will be given intramuscularly at different intervals followed by a challenge with P. vivax infected mosquitoes. Safety, immunogenicity and efficacy parameters will be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria, Plasmodium Vivax
CountriesUnited States
CollaboratorsThe PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR), United States Department of Defense, GlaxoSmithKline

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 7, 2010
Enrollment StartJul 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.0 years ago

Interventions

VMP001biological

Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B

P. vivax sporozoite challengeother

P. vivax sporozoite challenge