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

  • STATUS
    Recruiting
  • End date
    May 30, 2022
  • participants needed
    2000
  • sponsor
    Serum Institute of India Pvt. Ltd.
Updated on 24 January 2021

Summary

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.

Description

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.

Details
Condition Prevention of TB Recurrence
Treatment Placebo, VPM1002 (Recombinant BCG Vaccine)
Clinical Study IdentifierNCT03152903
SponsorSerum Institute of India Pvt. Ltd.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have Prevention of TB Recurrence?
Do you have any of these conditions: Do you have Prevention of TB Recurrence??
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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