Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.
* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
18
vaccine
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States
Safety - Most Frequently Reported Adverse Events and Grade
An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to study drug or clinically significant. Grade 1: Mild Grade 2: Moderate Grade 3: Severe
Time frame: 30 days post vaccination
Anti-LSA-1 Antibody Response in Titer Units
Anti-LSA-1 Antibody Response in Titer Units on days 0, 28, 42 and 84
Time frame: days 0, 28, 42 (challenge day) and 84
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