CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Plasmodium falciparum sporozoites 2sites +2 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/NCT01465048
NCT01465048N/ACompleted
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A Pilot Study to Optimise Controlled Human Malaria Infections Using Plasmodium Falciparum Sporozoites Administered by Needle and Syringe

University of Oxford·interventional·Posted Nov 4, 2011·Updated Jun 24, 2013

In Brief

A clinical study evaluating Plasmodium falciparum sporozoites 2sites, Plasmodium falciparum sporozoites 1 site, and 1 other intervention for Malaria and Plasmodium Falciparum. Completed, enrolled 18 participants across 1 site.

Detailed Summary

This is an open label, human pilot study to optimise controlled human malaria infection (CHMI) administered by Plasmodium falciparum sporozoites (PfSPZ. Volunteers will be inoculated with PfSPZ Challenge. The route of administration and dose will vary in order to identify the optimal regimen that achieves the greatest infection rate in volunteers with Plasmodium falciparum. All volunteers recruited will be healthy adults aged between 18 and 45 years. Safety and infectivity data will be collected for each of the regimens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria, Plasmodium Falciparum
CountriesUnited Kingdom
CollaboratorsSanaria Inc.

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2011
Enrollment StartOct 1, 2011
Primary CompletionFeb 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.7 years ago

Interventions

Plasmodium falciparum sporozoites 2sitesbiological

Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 2,500 sporozoites, 50ulx2, 2 intradermal injection sites

Plasmodium falciparum sporozoites 1 sitebiological

Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 2,500 sporozoites, 50ulx2, 2 intramuscular injection sites

Plasmodium falciparum sporozoites 1sitebiological

Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 25,000 sporozoites, 50ulx2, 2 intramuscular injection sites