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

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ClinicalTrials.gov Identifier: NCT03152903
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Serum Institute of India Pvt. Ltd.

April 28, 2017
May 15, 2017
February 28, 2018
December 15, 2017
August 20, 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03152903 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
Same as current
Not Provided
Not Provided
 
Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence in India
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 In India
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Prevention of TB Recurrence
  • Biological: VPM1002 (Recombinant BCG Vaccine)

    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.

  • Other: Placebo
    Single dose of Placebo is administered intradermally.
  • Experimental: VPM1002 (Recombinant BCG vaccine)
    Intervention: Biological: VPM1002 (Recombinant BCG Vaccine)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
Same as current
November 20, 2019
August 20, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Yes
Contact: Dr Prasad Kulkarni, MD +91-20-26602384 drpsk@seruminstitute.com
Contact: Dr Sajjad Desai, MD +91-20-26602781 sajjad.desai@seruminstitute.com
India
 
 
NCT03152903
VPM1002-IN-3.01TBR
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Serum Institute of India Pvt. Ltd.
Serum Institute of India Pvt. Ltd.
Not Provided
Not Provided
Serum Institute of India Pvt. Ltd.
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP