Clinical trial NCT03152903: Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prevention of TB Recurrence
Keywords: Recombinant BCG vaccine
Category 1 pulmonary tuberculosis
Recurrence
Efficacy
Lead sponsor: Serum Institute of India Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of bacteriologically confirmed TB recurrence cases
timeFrame: 2-12 months post-vaccination
Secondary outcomes:
measure: Percentage of overall TB recurrence (i.e. either bacteriologically confirmed or clinically diagnosed TB recurrence)
timeFrame: 2-12 months post-vaccination
measure: Safety assessed by Solicited local and regional reactogenicity and Unsolicited adverse events and SAEs
timeFrame: Throughout study participation i.e.12 months post-vaccination
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research
city: Hyderabad
country: India
facility: Mahavir Hospital & Research Centre, Hyderabad
state: Andhra Pradesh
city: Jammu
country: India
facility: Government Medical College, Jammu
state: Jammu and Kashmir
city: Pune
country: India
facility: B.J. Govt. Medical College and Sassoon General Hospitals
state: Maharashtra
city: Sevagram
country: India
facility: Mahatma Gandhi Institute of Medical Sciences, Sevagram
state: Maharashtra
city: Ludhiana
country: India
facility: Christian Medical College and Hospital, Ludhiana
state: Punjab
city: Chennai
country: India
facility: MV Hopsital for Diabetes Pvt Ltd, Chennai
state: Tamil Nadu
city: Chennai
country: India
facility: Sri Ramachandra Hospital Chennai
state: Tamil Nadu
city: Puducherry
country: India
facility: Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
state: Tamil Nadu
city: Vellore
country: India
facility: Christian Medical College and Hospital, Vellore
state: Tamil Nadu
Study officials:
References: