A Trial For The Study of Falciparum Malaria Protein 013 Administered Via Intramuscular Injection in Healthy Adults

Phase 1 Unknown 46 enrolled U.S. Army Medical Research and Development Command Walter Reed Army Institute of Research (WRAIR) · collab

Non-randomizedParallel-groupOpen-labelPrevention

Summary

A Phase 1, open label clinical study to evaluate the safety, immunogenicity, tolerability and efficacy of Plasmodium falciparum Malaria Protein 013 (FMP013) combined with (ALF with QS-21), saponin molecule derived from the bark of Quillaja species (ALFQ)) in healthy adult volunteers at different doses and dosing schedules.

Timeline

Start: 2020-03-20
Primary completion: 2023-07
Completion: 2023-12

Publications

Hutter JN, Robben PM, Lee C, Hamer M, Moon JE, Merino K, Zhu L, Galli H, Quinn X, Brown DR, Duncan E, Bolton J, Zou X, Angov E, Lanar DE, Rao M, Matyas GR, Beck Z, Bergmann-Leitner E, Soisson LA, Waters NC, Ngauy V, Regules J, Dutta S. First-in-human assessment of safety and immunogenicity of low and high doses of Plasmodium falciparum malaria protein 013 (FMP013) administered intramuscularly with ALFQ adjuvant in healthy malaria-naive adults. Vaccine. 2022 Sep 22;40(40):5781-5790. doi: 10.1016/j.vaccine.2022.08.048. Epub 2022 Aug 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	ALFQ	Other / unclassified	0.2 ml	Intramuscular
Comparator	ALFQ	Other / unclassified	0.5 ml	Intramuscular
Comparator	ALFQ	Other / unclassified	1 ml	Intramuscular
Comparator	FMP013	Vaccine	8 ug	Intramuscular
Comparator	FMP013	Vaccine	20 ug	Intramuscular
Comparator	FMP013	Vaccine	40 ug	Intramuscular

A Trial For The Study of Falciparum Malaria Protein 013 Administered Via Intramuscular Injection in Healthy Adults

Summary

Timeline

Publications

Drugs

Indications