Coadministration of GA2 Sporozoites With Adjuvants

Phase 0 Unknown 45 enrolled Leiden University Medical Center

RandomizedSequentialDouble-blindPrevention

Summary

This study will assess the coadministration of genetically attenuated Plasmodium falciparum ∆mei2 (GA2) sporozoites with adjuvants (BCG and YF-17D vaccination and imiquimod cream). Primary outcomes will be safety, tolerability and protective efficacy against CHMI.

Timeline

Start: 2023-02-03
Primary completion: 2024-12
Completion: 2024-12

Publications

Roozen GVT, van Schuijlenburg R, Hensen ADO, Koopman JPR, Lamers OAC, Geurten FJA, Sijtsma JC, Baalbergen E, Janse JJ, Chevalley-Maurel S, Naar CM, Bezemer S, Kroeze H, van de Stadt HJF, de Visser B, Meij P, Tihaya MS, Colstrup E, Iliopoulou E, de Bes-Roeleveld HM, Wessels E, van der Stoep MYEC, Janse CJ, Murugan R, Franke-Fayard BMD, Roestenberg M. Single immunization with genetically attenuated Pf∆mei2 (GA2) parasites by mosquito bite in controlled human malaria infection: a placebo-controlled randomized trial. Nat Med. 2025 Jan;31(1):218-222. doi: 10.1038/s41591-024-03347-2. Epub 2025 Jan 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BCG	Vaccine	0.1 ml	Other
Subject	GA2	Unknown	—	Other
Subject	Imiquimod	Other / unclassified	250 mg	Topical
Subject	YF-17D	Vaccine	0.1 ml	Other

Coadministration of GA2 Sporozoites With Adjuvants

Summary

Timeline

Publications

Drugs

Indications