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Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485)

NCT01151189 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2016-05-24

Study results available
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Summary

This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of MVA85A/AERAS-485 in healthy, HIV-infected adults.

This study consists of 650 adults subjects (ages 18-50 years of age inclusive) who will receive study vaccine or placebo at Study Day 0 and again 6-9 months later. Samples for real-time evaluation of immunogenicity were to be collected from 70 subjects (immunogenicity analysis set).

Conditions

Interventions

BIOLOGICAL

MVA85A/AERAS-485

Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485.

BIOLOGICAL

Placebo

Subjects received an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Aeras

    lead OTHER

Principal Investigators

  • Souleymane Mboup · Hopital Aristide Le Dantec

  • Robert Wilkinson · University of Cape Town

  • Bernard Landry · Aeras

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-05-31
Completion
2014-09-30

Countries

  • Senegal
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
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 NCT01151189 on ClinicalTrials.gov