The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.
The study begins with the US phase in which 26 volunteers aged 18 to 50 years will be enrolled to receive an investigational malaria vaccine. The vaccine is made of a malaria protein FMP010 mixed in the adjuvant AS01B. Since this vaccine has not yet been in humans, first, 5 volunteers will get a small (10 µg) dose of FMP010 in AS01B. If it is safe, then 20 volunteers will get 50 µg FMP010 in AS01B. Vaccinations are given IM in the deltoid of the non-dominant arm, every month for 3 months. After each vaccination, the subjects will follow up at clinical trials for evaluation of any adverse events. There will be blood draws to assess safety of the vaccine as well as the level of immune response generated to the vaccine. Upon receipt of preliminary safety results, the Kenya phase begins in which 30 volunteers who are randomized to receive either 50 µg FMP010 in AS01B (20) or the rabies vaccine (10). Vaccination and is on the same schedule as in the US phase and follow-up is for 112 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
26
Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK
Department of Clinical Trials, WRAIR
Silver Spring, Maryland, United States
USAMRU-K/ KEMRI. Walter Reed Project
Kombewa, Kisumu, Nyanza Province, Kenya
Number of solicited adverse events
Occurrence and intensity of solicited symptoms on day of vaccination and Days 1-7 after each vaccination
Time frame: 7 days
Number of unsolicited adverse events
Occurrence and intensity of unsolicited symptoms over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination
Time frame: 30 days
Number of serious adverse events
Time frame: 1 year
Percent parasite growth inhibition
Functionality of antibodies elicited as measured by percent parasite growth inhibition in GIA against homologous (FVO) and heterologous (3D7) parasites
Time frame: Up to 112 days
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