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

A Multicenter Phase II/III Double – Blind, Randomized, Placebo Controlled study To evaluate the Efficacy and the safety of VPM1002 in the prevention of tuberculosis (TB) recurrence In pulmonary TB patients after successful TB treatment.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/008266

Enrollment

2000

Registered

2017-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pulmonary TB Patients after successfull TB treatment and were declared cured

Interventions

Intervention1: VPM1002: The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis rBCG?ureC::Hly+, freeze-dried and standardized to number of viable mycobacteria (colony for

CFU) per application Control Intervention1: Placebo: Freeze dried powder containing dextran, glucose and water for injection as solvent

Eligibility

Inclusion criteria

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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Bacteriologically confirmed TB recurrence casesTimepoint: From two months to 12 months after vaccination	—

Secondary

Measure	Time frame
Efficacy: Overall TB recurrence (Bacteriologically confirmed and clinically diagnosed cases) Safety: o Solicited local and regional reactogenicity events within 2 months following study vaccination o Unsolicited adverse events o SAEs throughout the study periodTimepoint: From two months to twelve months after vaccination	—

Countries

Bangladesh, India

Contacts

Public ContactDr Sajjad Desai

Serum Institute of India Pvt. Ltd.

drpsk@seruminstitute.com02026602384

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026