NCT00312663

Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America

A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS01B Candidate Malaria Vaccine in Malaria-naive Adults Living in the United States

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.

Detailed description

* Controlled challenge, Phase I/IIa WRAIR study. * Healthy, malaria-naive adults aged 18 - 50 years. * 2 groups, 5 subjects in group A (10µg dose) and 13 subjects in group B(50µg dose). * Control: none for immunization phase; infectivity controls for challenge and rechallenge phases. Six infectivity controls per day of challenge will be enrolled for the challenge phases, with 3 alternates available for challenge if needed. * Vaccination schedule of 0, 1 months. * Challenge of up to 13 subjects in Group B. * Contingent upon short term efficacy, rechallenge of initially protected subjects 6 months (+/- 2 months) after second dose of vaccine. * Self-contained study. * Duration of the study, per subject: approximately 15 months (screening, enrollment, vaccination, challenge and rechallenge). * Data collection will be by done onsite.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
BIOLOGICAL	Falciparum Malaria Protein 11 with AS01B adjuvant.	malaria experimental vaccine

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-10-01
• Completion: 2007-04-01
• First posted: 2006-04-10
• Last updated: 2018-11-26
• Results posted: 2018-11-26

Locations

1 site across 1 country: United States