Immunization Via Mosquito Bite With Radiation-attenuated Sporozoites

Summary

This study is to assess the safety, tolerability, and biomarkers of protection in healthy malaria-naïve adults, who will receive bites from Anopheles stephensi mosquitoes either infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected (mock-immunization).

Timeline

Start

2014-01-24

Primary completion

2016-12-20

Completion

2017-02

Publications

• Oyong DA, Duffy FJ, Neal ML, Du Y, Carnes J, Schwedhelm KV, Hertoghs N, Jun SH, Miller H, Aitchison JD, De Rosa SC, Newell EW, McElrath MJ, McDermott SM, Stuart KD. Distinct immune responses associated with vaccination status and protection outcomes after malaria challenge. PLoS Pathog. 2023 May 17;19(5):e1011051. doi: 10.1371/journal.ppat.1011051. eCollection 2023 May.
• Du Y, Hertoghs N, Duffy FJ, Carnes J, McDermott SM, Neal ML, Schwedhelm KV, McElrath MJ, De Rosa SC, Aitchison JD, Stuart KD. Systems analysis of immune responses to attenuated P. falciparum malaria sporozoite vaccination reveals excessive inflammatory signatures correlating with impaired immunity. PLoS Pathog. 2022 Feb 2;18(2):e1010282. doi: 10.1371/journal.ppat.1010282. eCollection 2022 Feb.
• Sedegah M, Hollingdale MR, Ganeshan H, Belmonte M, Huang J, Belmonte A, Inoue S, Velasco R, Hickey B, Teneza-Mora N, Lumsden J, Reyes S, Banania JG, Reyes A, Guzman I, Richie TL, Epstein JE, Villasante E. IMRAS-Immunization with radiation-attenuated Plasmodium falciparum sporozoites by mosquito bite: Cellular immunity to sporozoites, CSP, AMA1, TRAP and CelTOS. PLoS One. 2021 Aug 20;16(8):e0256396. doi: 10.1371/journal.pone.0256396. eCollection 2021.
• Hickey B, Teneza-Mora N, Lumsden J, Reyes S, Sedegah M, Garver L, Hollingdale MR, Banania JG, Ganeshan H, Dowler M, Reyes A, Tamminga C, Singer A, Simmons A, Belmonte M, Belmonte A, Huang J, Inoue S, Velasco R, Abot S, Vasquez CS, Guzman I, Wong M, Twomey P, Wojnarski M, Moon J, Alcorta Y, Maiolatesi S, Spring M, Davidson S, Chaudhury S, Villasante E, Richie TL, Epstein JE. IMRAS-A clinical trial of mosquito-bite immunization with live, radiation-attenuated P. falciparum sporozoites: Impact of immunization parameters on protective efficacy and generation of a repository of immunologic reagents. PLoS One. 2020 Jun 17;15(6):e0233840. doi: 10.1371/journal.pone.0233840. eCollection 2020.

Drugs

Indications