Overview

This trial is active, not recruiting.

Condition tuberculosis
Treatment japanese (tokyo) 172 bacille calmette guerin (bcg).
Phase phase 4
Sponsor University of Cape Town
Collaborator Aeras
Start date March 2001
End date August 2006
Trial size 12000 participants
Trial identifier NCT00242047, UCT REC 271/2000

Summary

An open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, in the prevention of tuberculosis during the first two years of life.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
Prevention of tuberculosis with bacteriological or histological confirmation, or meeting strict clinical criteria,in the first 2 years of life.
time frame:

Secondary Outcomes

Measure
Comparison of Rate of Adverse Events.
time frame:
Comparison of Mortality Rates.
time frame:
Microbiological diagnosis of tuberculosis in a primary care setting.
time frame:
Rating of diagnostic scoring systems.
time frame:
Case definition of tuberculosis.
time frame:

Eligibility Criteria

Male or female participants up to 24 hours old.

Inclusion Criteria: 1. The child must be eligible to receive routine BCG vaccination. 2. The child must be born at one of the five hospitals taking part in the study and be a resident in the study area. 3. The mother must have had an opportunity to become informed about the study, either through pre-natal classes and a follow-up visit or, if time and the situation permits, after the mother presents at the hospital or birthing facility and before or after the child is born. 4. After being informed about the study, the mother gives consent for the infant to be enrolled and signs a consent form. Exclusion Criteria: 1. The mother fails to give informed consent. 2. The child has a medical condition which contraindicates vaccination during the first 24 hours of life (e.g., birth weight below 2,500 grams). 3. The infant is hospitalized outside of the study area before vaccination has been given (e.g. transferred to a hospital in Cape Town because of respiratory distress).

Additional Information

Official title Randomized, Controlled Trial Comparing Efficacy of Percutaneous and Intradermal Vaccination With Japanese (Tokyo) 172 BCG in the Prevention of Tuberculosis In Infants Vaccinated at Birth
Principal investigator Gregory Hussey, FCCH
Description This is an open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, obtained from the BCG laboratory in Tokyo, Japan, in the prevention of tuberculosis, with bacteriological or histological confirmation, or meeting strict clinical criteria, during the first two years of life. The comparison of the two methods is necessary because the intradermal method is almost universally preferred, without direct evidence from a clinical trial. The intradermal method provides for more accurate dosing and produces a higher rate of tuberculin skin test conversion, but neither of these factors has been shown to correlate with efficacy of BCG vaccination. The percutaneous method is much simpler and, if shown to be equally effective, could become a preferred method. The Japanese strain was chosen because it is the one commercially available strain produced for both intradermal and percutaneous administration, and because a seed lot from this strain was previously used to produce BCG for the South African BCG vaccination program.
Trial information was received from ClinicalTrials.gov and was last updated in October 2005.
Information provided to ClinicalTrials.gov by University of Cape Town.