Clinical trial NCT00242047: Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tuberculosis
Keywords: Tuberculosis.
Children.
Vaccine.
BCG.
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Aeras
name: Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan.
First posted: 2005-10-19
Enrollment: 12000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility 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).

Primary outcomes:
measure: Prevention of tuberculosis with bacteriological or histological confirmation, or meeting strict clinical criteria,in the first 2 years of life.
Secondary outcomes:
measure: Comparison of Rate of Adverse Events.
measure: Comparison of Mortality Rates.
measure: Microbiological diagnosis of tuberculosis in a primary care setting.
measure: Rating of diagnostic scoring systems.
measure: Case definition of tuberculosis.
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, University of Cape Town.
state: Western Cape
Study officials:
affiliation: South African Tuberculosis Vaccine Initiative
name: Gregory Hussey, FCCH
role: PRINCIPAL_INVESTIGATOR
affiliation: Aeras
name: Larry Geiter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hawkridge A, Hatherill M, Little F, Goetz MA, Barker L, Mahomed H, Sadoff J, Hanekom W, Geiter L, Hussey G; South African BCG trial team. Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial. BMJ. 2008 Nov 13;337:a2052. doi: 10.1136/bmj.a2052.