Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00242047
• Other study ID #: UCT REC 271/2000
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 18, 2005
• Last updated: October 18, 2005
• Start date: March 2001
• Est. completion date: August 2006

Study information

• Verified date: November 2004
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12000
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).

Locations

Country	Name	City	State
South Africa	South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, University of Cape Town.	Cape Town	Western Cape

Sponsors (3)

Lead Sponsor	Collaborator
University of Cape Town	Aeras, Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of tuberculosis with bacteriological or histological confirmation, or meeting strict clinical criteria,in the first 2 years of life.
Secondary	Comparison of Rate of Adverse Events.
Secondary	Comparison of Mortality Rates.
Secondary	Microbiological diagnosis of tuberculosis in a primary care setting.
Secondary	Rating of diagnostic scoring systems.
Secondary	Case definition of tuberculosis.

External Links

•   SATVI website