NCT01157897

Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1/2a, non-randomized, open label, dose escalation study in healthy, malaria-naïve adults aged 18 to 55 years (inclusive). The vaccine will be administered with GlaxoSmithKline Biologicals' adjuvant system AS01B. This is a first-in-human study of VMP001; therefore the study design will incorporate a dose-escalation phase evaluating 15 µg, 30 µg, and 60 µg doses of VMP001 in 500 µL of AS01B. A total of 30 volunteers, divided into 3 groups (10 in each group), will receive 3 doses of the VMP001/AS01B vaccine. Group 1 will receive 15 µg of VMP001, Group 2 will receive 30 µg of VMP001, and Group 3 will receive 60 µg of VMP001 at each immunization. The dose of AS01B will be 500 µL for all groups. The first and second dose in each group will be separated by 28 days. The third dose in the three groups will be given at intervals scheduled to normalize the time to challenge between the last immunization and challenge. The second and third dose in Group 1 will be separated by 56 days, Group 2 by 42 days and Group 3 by 28 days. The challenge will occur 2 weeks following the third immunization. A group of 6-12 infectivity controls will begin participation in the study at the challenge stage. They will not receive any immunizations or placebos prior to challenge. All volunteers will receive a standard treatment regimen consisting of chloroquine and primaquine on the day that parasitemia is detected. Volunteers who do not become parasitemic will also begin the same treatment regimen on day 28 following the challenge (study day 126). \> \> Safety and immunogenicity will be evaluated during the study through the final study visit 6 months after challenge (study day 280).

Conditions

• Malaria
• Plasmodium Vivax

Interventions

Type	Name	Description
BIOLOGICAL	VMP001	Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
OTHER	P. vivax sporozoite challenge	P. vivax sporozoite challenge

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-07-07
• Last updated: 2019-05-29
• Results posted: 2019-05-29

Locations

1 site across 1 country: United States