Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali

Summary

Background: Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death. Scientists want to learn if a vaccine can stop it from spreading to other people. Objective: To test how well an experimental malaria vaccine works to decrease malaria infections. Eligibility: Healthy people ages 5 and older who live in Doneguebougou, Mali, and surrounding areas Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests EKG Participants will be randomly assigned to get either the experimental vaccine or an approved vaccine. They will not know which they are getting. Participants will have a visit about a week before their first vaccine. They will take a medicine that kills malaria. They will take it at the clinic the next 2 days. Participants ages 5-8 will take the drug again 2 weeks before their third vaccine. Participants get the vaccine through a needle in the arm. They will have visits 1, 3, 7, and 14 days after. They will have blood tests or finger pricks. Participants will get another vaccine 1 and 6 months later. Participants will have blood tests once a month. At these visits they may also have urines tests or mosquito feeds. For the feeds a cup full of mosquitoes will be placed on arms or legs for 15-20 minutes. Participants will have visits twice a month for 4 months after their last vaccine.

Timeline

Start

2019-04-24

Primary completion

2021-07-30

Completion

2022-10-31

Publications

• Background MacDonald NJ, Nguyen V, Shimp R, Reiter K, Herrera R, Burkhardt M, Muratova O, Kumar K, Aebig J, Rausch K, Lambert L, Dawson N, Sattabongkot J, Ambroggio X, Duffy PE, Wu Y, Narum DL. Structural and Immunological Characterization of Recombinant 6-Cysteine Domains of the Plasmodium falciparum Sexual Stage Protein Pfs230. J Biol Chem. 2016 Sep 16;291(38):19913-22. doi: 10.1074/jbc.M116.732305. Epub 2016 Jul 18.
• Background Tachibana M, Wu Y, Iriko H, Muratova O, MacDonald NJ, Sattabongkot J, Takeo S, Otsuki H, Torii M, Tsuboi T. N-terminal prodomain of Pfs230 synthesized using a cell-free system is sufficient to induce complement-dependent malaria transmission-blocking activity. Clin Vaccine Immunol. 2011 Aug;18(8):1343-50. doi: 10.1128/CVI.05104-11. Epub 2011 Jun 29.
• Background Farrance CE, Rhee A, Jones RM, Musiychuk K, Shamloul M, Sharma S, Mett V, Chichester JA, Streatfield SJ, Roeffen W, van de Vegte-Bolmer M, Sauerwein RW, Tsuboi T, Muratova OV, Wu Y, Yusibov V. A plant-produced Pfs230 vaccine candidate blocks transmission of Plasmodium falciparum. Clin Vaccine Immunol. 2011 Aug;18(8):1351-7. doi: 10.1128/CVI.05105-11. Epub 2011 Jun 29.
• Cao Y, da Silva Araujo M, Lorang CG, Dos Santos NAC, Tripathi A, Vinetz J, Kumar N. Distinct immunogenicity outcomes of DNA vaccines encoding malaria transmission-blocking vaccine target antigens Pfs230D1M and Pvs230D1. Vaccine. 2025 Feb 15;47:126696. doi: 10.1016/j.vaccine.2024.126696. Epub 2025 Jan 8.

Drugs

Indications