Clinicaltrials.gov identifier: NCT01157897

 

Partner trial identifier: WRAIR1692

 

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

 

 

Project description: Study of VMP001 and AS01B in healthy malaria-naïve adults*

 

This Phase 1/2a study, conducted in malaria-naïve adults in the United States, aimed to evaluate the immunogenicity, safety, and protective efficacy of the Plasmodium vivax circumsporozoite protein-based vaccine VMP001 adjuvanted in GlaxoSmithKline’s (GSK) AS01B.

Subjects were randomized among three groups, each receiving multiple intramuscular vaccinations of VMP001 at one of three dose levels (15 µg, 30 µg, and 60 µg) in 500 µL of AS01B.

The study was designed with two objectives:
 

1. Assess the safety and reactogenicity of the VMP001/AS01B vaccine in malaria-naïve adults by monitoring for occurrence of solicited signs and symptoms during a seven-day follow-up period after each vaccination, occurrence of unsolicited symptoms during a 28-day follow-up period after each vaccination, and the occurrence of serious adverse events after the first dose of vaccine during the study follow-up period.

2. Quantify the humoral immune response via anti-VMP001 antibody titer.

Enrollment: 48