CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01) +3 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/NCT01366534
NCT01366534Phase 2Completed
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Safety, Immunogenicity and Efficacy Against Malaria in the Sporozoite Challenge Model of One Dose of Ad35.CS.01 Malaria Vaccine Followed by Two Doses of Malaria 257049 Vaccine in Healthy Malaria-naïve Adults

GlaxoSmithKline·interventional·Posted Jun 6, 2011·Updated Jun 18, 2019

In Brief

A Phase 2 clinical trial evaluating Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01), GSK Biologicals' malaria vaccine 257049 (2 doses), and 2 other interventions for Malaria. Completed, enrolled 67 participants across 1 site.

Detailed Summary

This study will evaluate whether administration of two investigational malaria vaccines (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection against malaria infection as compared to protection induced by the 257049 vaccine alone. The study will also evaluate the safety and the immune response to the new combination of the two experimental malaria vaccines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUnited States
CollaboratorsThe PATH Malaria Vaccine Initiative (MVI), Crucell Holland BV

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 6, 2011
Enrollment StartAug 10, 2011
Primary CompletionFeb 27, 2012
Study CompletionJul 3, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.1 years ago

Interventions

Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01)biological

One dose will be administered intramuscularly at Study Day 0.

GSK Biologicals' malaria vaccine 257049 (2 doses)biological

Two doses will be administered intramuscularly at monthly intervals

GSK Biologicals' malaria vaccine 257049 (3 doses)biological

Three doses will be administered intramuscularly at monthly intervals

Sporozoite challengeother

Subjects were challenged with sporozoite-infected mosquitoes to determine whether immune protective response had been induced by vaccination.