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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.

Brief 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.

Condition or disease Intervention/treatment Phase
Prevention of TB Recurrence Biological: VPM1002 (Recombinant BCG Vaccine) Other: Placebo Phase 2 Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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 In India
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : August 20, 2019
Estimated Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VPM1002 (Recombinant BCG vaccine) 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.


Placebo Comparator: Placebo Other: Placebo
Single dose of Placebo is administered intradermally.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152903


Contacts
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Contact: Dr Prasad Kulkarni, MD +91-20-26602384 drpsk@seruminstitute.com
Contact: Dr Sajjad Desai, MD +91-20-26602781 sajjad.desai@seruminstitute.com

Locations
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India
Mahavir Hospital & Research Centre, Hyderabad Recruiting
Hyderabad, Andhra Pradesh, India, 500004
Contact: Dr Penmetsa Sitarama Raju    +91-9247251879    psraju47@gmail.com   
B.J. Govt. Medical College and Sassoon General Hospitals Recruiting
Pune, Maharashtra, India, 411001
Contact: Dr Sushant Meshram    +91-20-26052419    drsushant.in@gmail.com   
Mahatma Gandhi Institute of Medical Sciences, Sevagram Recruiting
Sevagram, Maharashtra, India, 442102
Contact: Dr B S Garg, MD    +91-9422141693    gargbs@gmail.com   
Christian Medical College and Hospital, Ludhiana Recruiting
Ludhiana, Punjab, India, 141008
Contact: Dr Clarence Samuel       clarencejs@yahoo.com   
MV Hopsital for Diabetes Pvt Ltd, Chennai Recruiting
Chennai, Tamil Nadu, India, 600013
Contact: Dr Vijay Viswanathan    +91-44-25954913    drvijay@mvdiabetes.com   
Sponsors and Collaborators
Serum Institute of India Pvt. Ltd.

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Responsible Party: Serum Institute of India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT03152903     History of Changes
Other Study ID Numbers: VPM1002-IN-3.01TBR
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Serum Institute of India Pvt. Ltd.:
Recombinant BCG vaccine
Category 1 pulmonary tuberculosis
Recurrence
Efficacy

Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes
Vaccines
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic