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NCT Number: NCT03152903

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

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.

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Key information

Conditions

Prevention of TB Recurrence Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females aged ≥18 and ≤65 years.
  • 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.
  • Must have a sputum sample showing bacteriologic confirmation of cure - defined as smear negative.
  • 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.
  • Participant must intend to remain in the area during the study period.

Exclusion criteria

  • Reactive serology for HIV
  • History of extrapulmonary TB
  • Known or suspected impairment of immunological function
  • Pregnant and / or lactating female participants

Treatment and study plan

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.

Placebo

Other

Single dose of Placebo is administered intradermally.

Primary outcomes

  1. Percentage of bacteriologically confirmed TB recurrence cases

    Time frame: 2-12 months post-vaccination

    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.

Secondary outcomes

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

    Time frame: 2-12 months post-vaccination

    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.

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

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

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

Sponsors and collaborators

Lead sponsor

Serum Institute of India Pvt. Ltd.

Industry

Registry information

Official study title

A Multicenter Phase II/III Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Efficacy And Safety Of VPM1002 In The Prevention Of Tuberculosis (TB) Recurrence In Pulmonary TB Patients After Successful TB Treatment

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
May 15, 2017
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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