A study to check the efficacy and safety of recombinant BCG vaccine in prevention of TB recurrence.
- Conditions
- Health Condition 1: null- Pulmonary TB Patients after successfull TB treatment and were declared cured
- Registration Number
- CTRI/2017/03/008266
- Lead Sponsor
- SERUM INSTITUTE OF INDIA PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Males or females aged more than or equal to 18 and less than or equal to 65 years
2. Bacteriologically confirmed Category I pulmonary TB patients (including controlled diabetics with HbA1c level less than or equal to 7% and non-diabetics) who successfully completed ATT as per national guidelines.
3. Must have a sputum sample showing bacteriologic confirmation of cure - defined as smear negative.
4.Female participants who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination
1. Reactive serology for HIV
2. History of extrapulmonary TB
3. Current or known history or family history of multidrug-resistant or extensively-drug-resistant TB
4. Known or suspected impairment of immunological function
5. Pregnant and / or lactating female participants.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method