A Phase 1/2 interventional study of Group A FMP2.1/AS01B and Group B FMP2.1/AS02A in Malaria, sponsored by U.S. Army Medical Research and Development Command. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by U.S. Army Medical Research and Development Command · Phase 1/2, Interventional, and Prevention
The purpose of this study is to determine whether 2 investigational malaria vaccines are safe as well as protective against malaria in adults living in the United States
35 volunteers aged 18 to 50 years will be enrolled to receive one of 2 investigational malaria vaccines. The vaccines are made of a malaria protein FMP2.1 mixed in 2 different adjuvants (AS01B and AS02A). Five volunteers will get a small (10 µg) dose of FMP2.1/AS01B since this vaccine has not yet been in humans. If it is safe, then 15 volunteers will get 50 µg FMP2.1 in AS02A and 15 will get 50 µg FMP2.1 in AS01B. All vaccines are given IM in the deltoid of the non-dominant arm, every 1 month for 3 months. After vaccination, the subjects will follow up at clinical trials for evaluation of any adverse events.
20 vaccinees (10 from each 50 µg vaccine group) will undergo primary sporozoite challenge 14-30 days after dose 3 via bite of 5 malaria-infected mosquitoes. All subjects will have a blood slide prepared and read to check for asexual P. falciparum parasitemia at least once daily beginning day 5 post challenge. Beginning on day 10 post challenge, subjects will check into a designated hotel, where 24 hour evaluation and care will be available for 10 nights. After this hotel phase, there will be follow-up visits to ensure there are no late developments of malaria in those who have not fallen ill (and thus are considered protected).
Any subject who tests positive for malaria will be treated with chloroquine. Efficacy readouts are complete protection or significant delay in patency defined as >2 days than the median prepatent period for the 6 infectivity controls. These 6 controls receive no vaccine and are enrolled for malaria-challenge only in order to provide comparison group for vaccinated individuals.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 41 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →U.S. Army Medical Research and Development Command is the lead sponsor of 151 studies on the registry; 8 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FMP 2.1 50 μg FMP2.1/AS01B
Biological: Group A FMP2.1/AS01B
FMP 2.1 50 μg FMP2.1/AS02A
Biological: Group B FMP2.1/AS02A
Also known as: FMP 2.1 50 μg FMP2.1/AS01B
Also known as: FMP 2.1 50 μg FMP2.1/AS02A
Number of adverse events
Time frame: Up to 1 year
Anti-AMA-1 antibody titers during Immunization Phase
Time frame: Up to 70 days
Anti-AMA-I antibody titers during Challenge Phase
Time frame: Up to 90 days
Anti-AMA-I antibodies as percent parasite growth inhibition during Immunization Phase
Time frame: Up to 70 days
Anti-AMA-I antibodies as percent parasite growth inhibition during Challenge Phase
Time frame: Up to 90 days
Time to parasitemia development after primary challenge following administration of the FMP2.l/ASOIB and FMP2.l /AS02A
Time frame: Up to 1 Year
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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U.S. Army Medical Research and Development Command