A study to check the efficacy and safety of recombinant BCG vaccine in prevention of TB recurrence.

Phase 2/3

Active, not recruiting

Conditions: Pulmonary TB Patients after successfull TB treatment and were declared cured

Brief Summary: This is Phase II/III study designed as a multicenter, double-blinded, randomized, placebo-controlled trial with two groups of adults successfully cured of TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be administered to former TB patients who have successfully completed Category I ATT, were declared cured. The vaccine will be administered intradermally.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Bacteriologically confirmed TB recurrence cases	From two months to 12 months after vaccination

Secondary Outcome Measures

Name	Time	Method
Efficacy:	Overall TB recurrence (Bacteriologically confirmed and clinically diagnosed cases)

Locations (15): B.J. Govt. Medical College and Sassoon General Hospitals Pune
🇮🇳
Pune, MAHARASHTRA, India
Christian Medical College and Hospital, Ludhiana
🇮🇳
Ludhiana, PUNJAB, India
Christian Medical College and Hospital, Vellore
🇮🇳
Chennai, TAMIL NADU, India
Dr. Sushila Nayar School of Public Health, Sewagram, Maharashtra
🇮🇳
Wardha, MAHARASHTRA, India
Govt. Medical College and Hospital, Nagpur
🇮🇳
Nagpur, MAHARASHTRA, India
International Center for Diarrheal Disease Research, Bangladesh
🇮🇳
Chandpur, India
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
🇮🇳
Pondicherry, PONDICHERRY, India
Kasturba Medical College, Manipal
🇮🇳
Udupi, KARNATAKA, India
KEM Hospital Research Centre Pune
🇮🇳
Pune, MAHARASHTRA, India
King George Hospital, Visakhapatnam
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
Scroll for more (5 remaining)
B.J. Govt. Medical College and Sassoon General Hospitals Pune
🇮🇳Pune, MAHARASHTRA, India
Dr Sanjay Gaikwad
Principal investigator
020-61268000
sangaiabdc@gmail.com