Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence

Serum Institute of India Pvt. Ltd.2,000 enrolled

Overview

This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be administered to calculate efficacy of the vaccine against TB recurrence.

The study is designed as a multicenter, double-blinded, randomized, placebo-controlled trial with two groups of category 1 pulmonary TB patients who have successfully completed ATT and declared cured by bacteriological confirmation. The eligible participants will be randomized in 1:1 ratio to receive single dose of either VPM1002 or placebo. After study vaccination, participants will be followed up for one year. Any suspected TB case during follow up will be further evaluated and bacteriologically confirmed. Study participants will be actively followed up for 2 months post-vaccination for any solicited local and regional reaction. SAEs will be recorded and reported throughout study participation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

2,000

Conditions

Prevention of TB Recurrence

Interventions

VPM1002 (Recombinant BCG Vaccine)BIOLOGICAL

VPM1002 is a formulated, lyophilized cake of live recombinant Mycobacterium bovis rBCGÄureC::Hly+; VPM1002. VPM1002 is the active pharmaceutical ingredient. It is a genetically modified BCG vaccine derived from the Mycobacterium bovis BCG subtype Prague characterized as rBCGÄureC::Hly+. Single dose of VPM1002 is administered intradermally.

PlaceboOTHER

Single dose of Placebo is administered intradermally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males or females aged ≥18 and ≤65 years. 2. Bacteriologically confirmed Category I pulmonary TB patients (including controlled diabetics with HbA1c level ≤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. 5. Participant must intend to remain in the area during the study period. Exclusion Criteria: 1. Reactive serology for HIV 2. History of extrapulmonary TB 3. Known or suspected impairment of immunological function 4. Pregnant and / or lactating female participants

Locations (10)

International Centre for Diarrhoeal Disease Research

Dhaka, Bangladesh

Mahavir Hospital & Research Centre, Hyderabad

Hyderabad, Andhra Pradesh, India

Government Medical College, Jammu

Jammu, Jammu and Kashmir, India

Outcomes

Primary Outcomes

Percentage of bacteriologically confirmed TB recurrence cases

Percentage of TB recurrence patients who have previously been successfully treated for TB, were declared cure and are now diagnosed with a new episode of bacteriologically confirmed recurrent TB after at least 2 months from vaccination.

Time frame: 2-12 months post-vaccination

Secondary Outcomes

Percentage of overall TB recurrence (i.e. either bacteriologically confirmed or clinically diagnosed TB recurrence)

Percentage of TB recurrence patients who have previously been successfully treated by for TB, were declared cure and are now diagnosed with a new episode of either bacteriologically confirmed or clinically diagnosed recurrent TB after at least 2 months from vaccination.

Time frame: 2-12 months post-vaccination

Safety assessed by Solicited local and regional reactogenicity and Unsolicited adverse events and SAEs

* Solicited local and regional reactogenicity events within 2 months following study vaccination * Unsolicited adverse events and SAEs throughout the study period

Time frame: Throughout study participation i.e.12 months post-vaccination

Data from ClinicalTrials.gov

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