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

2014-08-27 03:45:16 | BioPortfolio

Summary

Purpose of the study is to determine whether LSA-1/AS02A combination malaria vaccine is effective at preventing malaria.

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 15 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 15 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 at the site.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Malaria

Intervention

Falciparum Malaria Protein 1 with AS02A adjuvant

Location

Walter Reed Army Institute of Research
Silver Spring
Maryland
United States
20910

Status

Completed

Source

Walter Reed Army Institute of Research (WRAIR)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:16-0400

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