CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Immunization with P. vivax irradiated sporozoitesbiological
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/NCT01082341
NCT01082341Phase 2Completed
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Phase 1 and Phase 2a Clinical Trial:Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites

Malaria Vaccine and Drug Development Center·interventional·Posted Mar 8, 2010·Updated Mar 23, 2018

In Brief

A Phase 2 clinical trial evaluating Immunization with P. vivax irradiated sporozoites for Malaria. Completed, enrolled 27 participants across 1 site.

Detailed Summary

It is possible to safely protect human volunteers immunized with P. vivax irradiated sporozoites from P. vivax challenge with live sporozoites.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesColombia
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Asoclinic Inmunología Ltda.

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2010
Enrollment StartJun 1, 2012
Primary CompletionMay 1, 2015
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.3 years ago

Interventions

Immunization with P. vivax irradiated sporozoitesbiological

Anopheles albimanus mosquitoes will be infected by artificial membrane feeding using blood from P. vivax infected donors. Once mosquitoes are positive will be irradiated at 15000 cGy and kept in boxes until use. 14 Fy(+) human volunteers in the experimental group will be immunized with 1,000-2,000 P. vivax irrad-spz bites. Seven Fy(+) volunteers in the control group will be exposed to non-infected mosquito bites. Six Fy(-) volunteers will be exposed to infective mosquito bites. For the challenge both the immunized and control groups will be exposed to 3 ± 1 infective mosquito bites. Volunteers will be closely monitored post infection and will be treated with antimalarials.