CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 67 enrolled
Drug / intervention
PfSPZ Challenge +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02115516
NCT02115516Phase 1Completed
CompareCT.gov

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

Sanaria Inc.·interventional·Posted Apr 16, 2014·Updated May 15, 2017

In Brief

A Phase 1 clinical trial evaluating PfSPZ Challenge and 0.9% Sodium Chloride (Placebo) for Malaria and Plasmodium Falciparum Malaria. Completed, enrolled 67 participants across 1 site.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria, Plasmodium Falciparum Malaria
CountriesGermany
CollaboratorsInstitute of Tropical Medicine, University of Tuebingen, German Federal Ministry of Education and Research

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 16, 2014
Enrollment StartApr 1, 2014
Primary CompletionDec 1, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.2 years ago

Interventions

PfSPZ Challengebiological

Aseptic, purified, vialed, cryopreserved, infectious P. falciparum sporozoites, strain NF54

0.9% Sodium Chloride (Placebo)biological