Safety and Efficacy of NF135 CPS Immunization

Terminated 43 enrolled Radboud University Medical Center The PATH Malaria Vaccine Initiative (MVI) · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

This is an open label, randomized, controlled clinical trial. The primary aim of this project is to determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxis against homologous and heterologous challenge infection.

Timeline

Start: 2019-04-01
Primary completion: 2021-02-01
Completion: 2021-02-01

Outcome

Outcome not reported

Stopped (Enrollment): “Subject withdrawals after temporal suspension of the trial (for personal, logistic reasons). At time of reinitiation the number of enrolled subjects did not meet the predefined threshold for continuation of the trial.”

Publications

Results van der Boor SC, Alkema M, van Gemert GJ, Teelen K, van de Vegte-Bolmer M, Walk J, van Crevel R, de Mast Q, Ockenhouse CF, Sauerwein RW, McCall MBB. Whole sporozoite immunization with Plasmodium falciparum strain NF135 in a randomized trial. BMC Med. 2023 Apr 7;21(1):137. doi: 10.1186/s12916-023-02788-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CPS-immunization	Vaccine	5 unknown	Other
Subject	CPS-immunization	Vaccine	15 unknown	Other
Background	Artemether	Small molecule	—	—
Background	Atovaquone	Small molecule	1000 mg	Oral
Background	Mefloquine	Unknown	—	—
Background	Proguanil	Small molecule	400 mg	Oral
Background	lumefantrine	Small molecule	—	—