CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
AdCh63 ME-TRAP +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/NCT00890760
NCT00890760Phase 2Completed

Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With AdCh63 ME-TRAP and MVA ME-TRAP

University of Oxford·interventional·Posted Apr 30, 2009·Updated Nov 29, 2012

In Brief

A Phase 2 clinical trial evaluating AdCh63 ME-TRAP, MVA ME-TRAP, and 2 other interventions for Malaria. Completed, enrolled 55 participants across 1 site.

Detailed Summary

Malaria affects around 515 million people each year, about a million of whom die from the disease. It is a major problem for those who live in affected areas as well as for travellers to affected areas. There is a great need for a safe, effective malaria vaccine. The purpose of this study is to test 2 new vaccination regimes that include a new malaria vaccine candidate, for their ability to prevent malaria infection. The vaccines are different types of virus which contain genetic information (DNA) from the malaria parasite. This genetic material is named ME-TRAP. The aim is to use these viruses to help the body make an immune response against the malaria parasite. Both viruses are inactivated so that they are unable to multiply within the body. The first vaccine virus is a weakened version of a common cold virus. Such adenoviruses occur in many strain types and commonly infect chimpanzees as well as people and this vaccine uses a strain originally derived from a chimpanzee. The vaccine is called AdCh63 ME-TRAP. The other virus is Modified Vaccinia Ankara Virus, (MVA), which is a safer form of the vaccine virus previously widely used for smallpox vaccination. The vaccine is called MVA ME-TRAP. This study will enable the investigators to assess: 1. The ability of different vaccine combinations to prevent malaria infection 2. The safety of the vaccine combinations in healthy volunteers 3. The response of the human immune system to the vaccines

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 30, 2009
Enrollment StartMar 1, 2009
Primary CompletionFeb 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.2 years ago

Interventions

AdCh63 ME-TRAPbiological

5 x 10\*10 vp IM

MVA ME-TRAPbiological

2 x 10\*8 pfu ID

Sporozoite challengeother

Infected mosquito bite

Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularlybiological

AdCh63 ME-TRAP 5 x 10\*10 vp MVA ME-TRAP 2 x 10\*8 pfu