Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and adolescents.
Phase II, double-blind, randomized, safety and immunogenicity trial with BCG vaccine as a comparator in 164 healthy adults and adolescents and with both positive and negative interferon gamma release assay (IGRA) test result. Objective: To evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC Participants meeting the inclusion and exclusion criteria will be randomized within a study cohort in a 1:1 ratio to receive a single dose of MTBVAC or BCG vaccine administered intradermally. Only HIV-negative participants will be eligible for enrolment. A total of 164 participants aged 12-65 years will be enrolled into one of two cohorts based on their based on the QFT-Plus assay results (QFT negative and QFT positive). Cohort 1 will include 82 QFT Negative participants Cohort 2 will include 82 QFT Positive participants. Study participants will be randomized in a 1:1 ratio within each cohort to receive MTBVAC (Total N=82, includes 41 QFT negative \& 41 QFT positive participants) or BCG (Total N=82, includes 41 QFT negative \& 41 QFT positive participants) Participants will be followed up for safety and Immunogenicity following vaccination via regular visits. At least 20% of the participants will be the adolescent population in each cohort in treatment and comparator arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
164
MTBVAC (BBV169) vaccine is a freeze-dried powder containing live attenuated Mycobacterium tuberculosis (M. tb), which is presented as a lyophilized product in a 10- dose vial. After reconstitution with 1.0 mL sterile water for injection, one dose (0.1mL) of vaccine contains 5 x10\^5 CFU live attenuated M. tb. One dose (0.1mL) of the MTBVAC (BBV169) vaccine is to be administered in the right deltoid region via the intradermal route.
Comparator vaccine: BCG Vaccine (TUBERVAC- Moscow strain), manufactured by Serum Institute of India, is a freeze-dried powder containing an attenuated strain of Bacillus Calmette-Guerin Mycobacterium bovis as a lyophilized product in a 10-dose vial. After reconstitution with 1.0 mL diluent (Sodium chloride) for injection, one dose (0.1mL) of BCG vaccine will be administered in the right deltoid region via the intradermal route.
Guru Teg Bahadur Hospital
Delhi, India
RECRUITINGAIIMS-Delhi
New Delhi, India
RECRUITINGTo evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC
Antigen-specific CD4 response - Frequencies and co-expression patterns of CD4 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG measured on Day 0, 28, 56, 90 and 180 using PBMC Intracellular cytokine assay
Time frame: Day 1 through Day 180
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Immediate adverse events
Occurrence of immediate adverse events within 30 minutes of vaccination
Time frame: 30 minutes of vaccination
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Solicited adverse events
Occurrence of Solicited adverse events within fourteen days of vaccination
Time frame: Day 1 through Day 14
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Injection site reactions
Injection site reactions will be followed-up for 90 days.
Time frame: Day 1 through Day 90
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Unsolicited adverse events
Occurrence of any unsolicited adverse events throughout the study duration
Time frame: Day 1 through Day 360
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Serious adverse events (SAE s)
Occurrence of serious adverse events (SAEs)
Time frame: Day 1 through Day 360
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- AESI (Adverse Event of Special Interest)
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AESI (Adverse Event of Special Interest) is to be considered throughout the trial period.
Time frame: Day 1 through Day 360