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A Phase II Study of H56:IC31 in Healthy Adolescents

NCT03265977 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-04-10

No results posted yet for this study

Summary

This clinical trial will evaluate safety, immunogenicity, and efficacy (prevention of Mtb infection as measured by IGRA conversions) of H56:IC31 in remotely BCG vaccinated adolescents.

Conditions

  • Tuberculosis Infection

Interventions

BIOLOGICAL

H56:IC31

The H56 antigen is a fusion protein created from 3 Mtb antigens: antigen 85B (Ag85B), ESAT-6, and Rv2660c.

OTHER

Placebo

Normal saline

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • Aurum Institute

    collaborator OTHER

  • South African Tuberculosis Vaccine Initiative

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • University of Bergen

    collaborator OTHER

  • National Institute for Medical Research, Tanzania

    collaborator OTHER_GOV

  • Aeras

    lead OTHER

Principal Investigators

  • Dereck Tait, MD · Aeras

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2021-04-30
Completion
2021-06-30

Countries

  • South Africa
  • Tanzania

Study Locations

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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 NCT03265977 on ClinicalTrials.gov