Safety and Protective Efficacy of Intravenous Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chemoprophylaxis

NCT02115516 Phase 1 COMPLETED

TÜCHMI-002 is a single center, randomized, placebo-controlled, double-blinded, PfSPZ Challenge dose finding trial with two chemoprophylactic regimens and subsequent controlled human malaria infection (CHMI).

Details

Lead sponsor	Sanaria Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	67
Start date	2014-04
Completion	2016-04

Conditions

• Malaria
• Plasmodium Falciparum Malaria

Interventions

• PfSPZ Challenge
• 0.9% Sodium Chloride (Placebo)

Primary outcomes

• Proportion of volunteers who become parasitemic, detected by thick blood film microscopy, within 21 days following CHMI after immunization using PfSPZ Challenge or placebo under chemoprophylaxis [PfSPZ Challenge Vaccine (PfSPZ-CVac) approach]. — Within 21 days following CHMI
• Occurrence of related Grade 3 adverse events (AEs) and SAEs from time of first administration of an immunizing regimen (chemoprophylactic antimalarial and PfSPZ Challenge) until the end of the study. — 19 months

Countries

Germany