MedTrace Logo

Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults

NCT01262976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-09-17

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human Immunodeficiency Virus (HIV)-positive adults aged 18 to 59 years, living in a tuberculosis endemic region.

Subjects will be followed-up for 3 years.

Subjects will be enrolled in 3 cohorts:

* HIV-positive adults on highly active antiretroviral therapy
* HIV-positive adults not on highly active antiretroviral therapy
* HIV-negative adults

Each cohort will have 2 groups.

Conditions

Interventions

BIOLOGICAL

GSK's investigational vaccine 692342

Intramuscular, 2 doses

BIOLOGICAL

Physiological saline

Intramuscular, 2 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-17
Primary Completion
2012-07-17
Completion
2015-06-04

Countries

  • India

More Related Trials

Entities

Diseases
Companies

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 NCT01262976 on ClinicalTrials.gov