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A Study of MVA85A in Healthy Infants

NCT00953927 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2797

Last updated 2016-05-24

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

MVA85A/AERAS-485

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

BIOLOGICAL

Candida Skin Test Antigen

1 test, administered once as a placebo control.

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • Aeras

    lead OTHER

Principal Investigators

  • Michele Tameris, MD · South African Tuberculosis Vaccine Initiative

  • Bernard Landry, MPH · Aeras

  • Helen McShane, MD · University of Oxford; Centre for Vaccinology & Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
126 Days
Max Age
182 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-10-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953927 on ClinicalTrials.gov