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.
Study is to evaluate the safety, reactogenicity, and immunogenicity fo the candidate Plasmodium falciparum malaria protein 10 (FMP010). Malaria-experienced adults will be enrolled and randomized into 2 groups. Subjects will receive full dose FMP010 antigen (approximately 50 μg) in 0.5 mL AS01B adjuvant or licensed rabies vaccine Rabipur (by Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent (sterile water) for injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
30
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
Rabipur is a licensed rabies vaccine.
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Vaccinations were given at 0-, 1-, 2-month interval, occurrence and intensity of solicited symptoms on day of vaccination (Day 0) and Days 1-7 after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe
Time frame: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7
Number of Subjects With Unsolicited Adverse Events at Specified Grades
Vaccinations were given at 0-, 1-, 2-month interval, number of subjects reporting unsolicited symptoms at specified grades over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe
Time frame: After each vaccination (Day 0), 30 day f/u period post vaccination
Number of Subjects With the Occurrence of Serious Adverse Events
Vaccinations were given at 0-, 1-, 2-month interval, number of subjects with the occurrence of serious adverse events at days 0-7 post vaccination
Time frame: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7 post vaccination
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) (not presented in results), at each time point at which blood samples are taken for serology. Peak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data.
Time frame: After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
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Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) at each time point at which blood samples are taken for serology. Peak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data.
Time frame: After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112