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Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents

NCT02378207 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-11-18

Study results available
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Summary

The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to provide leads for biomarkers of protection against tuberculosis. This study will complement one ongoing study (NCT02075203) evaluating the prevention of M. Tuberculosis infection using H4:IC31 (also known as AERAS-404).

Conditions

Interventions

BIOLOGICAL

H4:IC31

H4 contains Mtb antigens Ag85B and TB10.4

BIOLOGICAL

H56:IC31

H56 contains Mtb antigens ESAT-6, and Rv2660c

BIOLOGICAL

BCG

BIOLOGICAL

Control Sodium Chloride 0.9%

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • Statens Serum Institut

    collaborator OTHER

  • Aeras

    lead OTHER

Principal Investigators

  • Linda-Gail Bekker, MD · Desmond Tutu HIV Centre

  • Jim Kublin, MD · HVTN Core, FHCRC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-10-31
Completion
2016-12-09

Countries

  • 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 NCT02378207 on ClinicalTrials.gov