Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.
Plasmodium Falciparum
About this trial
This is an interventional prevention trial for Plasmodium Falciparum
Eligibility Criteria
Inclusion criteria: Healthy male or female volunteers aged between 18 and 35 years at the time of first vaccination who have given written consent for their participation in the study were included If the volunteer is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series Exclusion criteria: If a subject plans to take vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid will be excluded Volunteers with any confirmed or suspected immunosuppressive or immunodeficient conditions Family history of congenital or hereditary immunodeficiency History of allergic reactions to previous immunizations HBsAg positive subjects History of splenectomy Pregnant or lactating females will be excluded from the study
Sites / Locations
- U.S. Army Research Unit-Kenya
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
VACC 1 (RTS, S/AS01B)
VACC 2 (RTS, S/AS02A)
Rabipur (Rabies) Vaccine
RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.