Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults

Summary

This trial will evaluate whether relatively non-immune populations in endemic countries can effectively generate significant cellular and humoral immune responses that confer protection against P. falciparum infection after inoculation of aseptic, purified, vialed, metabolically active, non-replicating (live, radiation attenuated) Plasmodium falciparum sporozoites (PfSPZ Vaccine) administered intravenously (IV).

Timeline

Start

2014-04

Primary completion

2015-07

Completion

2015-08

Publications

• Jongo SA, Shekalaghe SA, Church LWP, Ruben AJ, Schindler T, Zenklusen I, Rutishauser T, Rothen J, Tumbo A, Mkindi C, Mpina M, Mtoro AT, Ishizuka AS, Kassim KR, Milando FA, Qassim M, Juma OA, Mwakasungula S, Simon B, James ER, Abebe Y, Kc N, Chakravarty S, Saverino E, Bakari BM, Billingsley PF, Seder RA, Daubenberger C, Sim BKL, Richie TL, Tanner M, Abdulla S, Hoffman SL. Safety, Immunogenicity, and Protective Efficacy against Controlled Human Malaria Infection of Plasmodium falciparum Sporozoite Vaccine in Tanzanian Adults. Am J Trop Med Hyg. 2018 Aug;99(2):338-349. doi: 10.4269/ajtmh.17-1014. Epub 2018 Jun 21.
• Zenklusen I, Jongo S, Abdulla S, Ramadhani K, Lee Sim BK, Cardamone H, Flannery EL, Nguyen T, Fishbaugher M, Steel RWJ, Betz W, Carmago N, Mikolajczak S, Kappe SHI, Hoffman SL, Sack BK, Daubenberger C. Immunization of Malaria-Preexposed Volunteers With PfSPZ Vaccine Elicits Long-Lived IgM Invasion-Inhibitory and Complement-Fixing Antibodies. J Infect Dis. 2018 Apr 23;217(10):1569-1578. doi: 10.1093/infdis/jiy080.

Drugs

Indications