CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2,797 enrolled
Drug / intervention
MVA85A/AERAS-485 +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/NCT00953927
NCT00953927Phase 2Completed
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Phase II Double-blinded Randomized Controlled Evaluation of MVA85A/AERAS-485 for Safety, Immunogenicity and Prevention of Tuberculosis in BCG-vaccinated, HIV-negative Infants

Aeras·interventional·Posted Aug 6, 2009·Updated May 24, 2016

In Brief

A Phase 2 clinical trial evaluating MVA85A/AERAS-485 and Candida Skin Test Antigen for Tuberculosis. Completed, enrolled 2,797 participants across 3 sites.

Detailed Summary

This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis or HIV infection. This study planned to enroll 2784 infants (126 to 182 days of age) who received study vaccine or control and were followed for 15 - 36 months. The study was conducted at a single site in South Africa.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesSouth Africa
CollaboratorsUniversity of Oxford, University of Cape Town

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartJul 1, 2009
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.9 years ago

Interventions

MVA85A/AERAS-485biological

Attenuated virus MVA vector with insertion. Single dose vaccine, 1 x 10\^8 pfu.

Candida Skin Test Antigenbiological

1 test, administered once as a placebo control.