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Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.

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ClinicalTrials.gov Identifier: NCT00242047
Recruitment Status : Unknown
Verified November 2004 by University of Cape Town.
Recruitment status was:  Active, not recruiting
First Posted : October 19, 2005
Last Update Posted : October 19, 2005
Sponsor:
Collaborators:
Aeras
Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan.
Information provided by:
University of Cape Town

Brief 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.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG). Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : March 2001
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources




Primary Outcome Measures :
  1. Prevention of tuberculosis with bacteriological or histological confirmation, or meeting strict clinical criteria,in the first 2 years of life.

Secondary Outcome Measures :
  1. Comparison of Rate of Adverse Events.
  2. Comparison of Mortality Rates.
  3. Microbiological diagnosis of tuberculosis in a primary care setting.
  4. Rating of diagnostic scoring systems.
  5. Case definition of tuberculosis.


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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242047


Locations
South Africa
South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, University of Cape Town.
Cape Town, Western Cape, South Africa, 7925
Sponsors and Collaborators
University of Cape Town
Aeras
Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan.
Investigators
Principal Investigator: Gregory Hussey, FCCH South African Tuberculosis Vaccine Initiative
Principal Investigator: Larry Geiter, PhD Aeras

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00242047     History of Changes
Other Study ID Numbers: UCT REC 271/2000
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: October 19, 2005
Last Verified: November 2004

Keywords provided by University of Cape Town:
Tuberculosis.
Children.
Vaccine.
BCG.

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections