TuberculosisPhase 4NCT00242047
Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.
A Phase 4 study testing Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG). in people with Tuberculosis, run by University of Cape Town at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 0 years to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).
- How many people
- 12,000 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2001to Aug 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child must be eligible to receive routine BCG vaccination.
- The child must be born at one of the five hospitals taking part in the study and be a resident in the study area.
- 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.
- After being informed about the study, the mother gives consent for the infant to be enrolled and signs a consent form.
Who cannot join
- The mother fails to give informed consent.
- The child has a medical condition which contraindicates vaccination during the first 24 hours of life (e.g., birth weight below 2,500 grams).
- 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).
Trial locations and contacts
1 site in 1 country.
South Africa1 site
South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, University of Cape Town.
Cape Town, Western Cape, 7925
About this study
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
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.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).
- Keywords
- Tuberculosis., Children., Vaccine., BCG.
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of tuberculosis with bacteriological or histological confirmation, or meeting strict clinical criteria,in the first 2 years of life.
Secondary outcomes (5)
Comparison of Rate of Adverse Events.
Comparison of Mortality Rates.
Microbiological diagnosis of tuberculosis in a primary care setting.
Rating of diagnostic scoring systems.
Case definition of tuberculosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startMar 2001
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12,000 participants
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Aeras, Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan.
- Investigators
- Gregory Hussey, FCCH, Principal investigator, South African Tuberculosis Vaccine InitiativeLarry Geiter, PhD, Principal investigator, Aeras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242047
- Sponsor's protocol ID
- UCT REC 271/2000
- Status last verified
- Nov 2004
- First submitted
- 18 Oct 2005
- Last updated
- 19 Oct 2005
- Results posted
- No
Publications
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.
PubMed 19008268
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00242047
- Acronym / sponsor ID
- UCT REC 271/2000
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis., Children., Vaccine., BCG.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Aeras, Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan.
- Study start
- Mar 2001
- Study completion
- Aug 2006
- First posted
- 19 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The child must be eligible to receive routine BCG vaccination.
- The child must be born at one of the five hospitals taking part in the study and be a resident in the study area.
- 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.
- After being informed about the study, the mother gives consent for the infant to be enrolled and signs a consent form.
Key exclusion criteria (3 listed)
- The mother fails to give informed consent.
- The child has a medical condition which contraindicates vaccination during the first 24 hours of life (e.g., birth weight below 2,500 grams).
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG). | Biological | – |
Primary outcome
Prevention of tuberculosis with bacteriological or histological confirmation, or meeting strict clinical criteria,in the first 2 years of life.
5 secondary outcomes
Comparison of Rate of Adverse Events.
Comparison of Mortality Rates.
Microbiological diagnosis of tuberculosis in a primary care setting.
Rating of diagnostic scoring systems.
Case definition of tuberculosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2005.
- Derived from this study: PubMed 19008268Hawkridge 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.
- SATVI websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Hussey, FCCH principal investigator
South African Tuberculosis Vaccine Initiative
Larry Geiter, PhD principal investigator
Aeras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG). in people with Tuberculosis, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of tuberculosis with bacteriological or histological confirmation, or meeting strict clinical criteria,in the first 2 years of life.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00242047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2005.