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

Plasmodium Falciparum Malaria Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

• NCT number: NCT00312663
• Study type: Interventional
• Source: U.S. Army Medical Research and Materiel Command
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2006
• Completion date: April 2007