Tuberculosis Vaccine in Healthy Indian Adults

NCT06438978 | Completed Phase 1 DMC

• 1 other identifier: BBIL/MTBVAC/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (8)

• To evaluate the safety and reactogenicity of MTBVAC Immediate reaction

  Adverse reactions after administration of each dose

  30 Minutes of vaccination.

• To evaluate the safety and reactogenicity of MTBVAC-Solicited adverse events

  Incidence, intensity, and the causality of all solicited adverse events during the 14-day follow up period after each dose.

  14 days

• To evaluate the safety and reactogenicity of MTBVAC-injection site reactions

  The injection site reactions will be followed-up for 90days.

  90 Days

• To evaluate the safety and reactogenicity of MTBVAC-unsolicited adverse events

  The occurrence of any unsolicited adverse events throughout the study duration

  Through out the trial duration till Day180 Days

• To evaluate the safety and reactogenicity of MTBVAC-Serious Adverse Events (SAEs)

  Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period.

  Through out the trial duration till Day180 Days

• To evaluate the safety and reactogenicity of MTBVAC-AESI (Adverse Event of Special Interest)

  AESI (Adverse Event of Special Interest) is to be considered throughout the trial period.

  Through out the trial period till Day180 Days

• To evaluate the safety and reactogenicity of MTBVAC-Hematological safety test levels before and after vaccination

  Hematological safety test levels before and after vaccination

  before and after vaccination on Day 0

• To evaluate the safety and reactogenicity of MTBVAC-Biochemical safety test levels before and after vaccination

  Biochemical safety test levels before and after vaccination

  before and after vaccination on Day 0

Secondary Outcomes (4)

• Cellular immune responses

  Days 28

• Cellular immune responses

  Days 90

• Cellular immune responses

  Days 180

• Antigen-specificCD4/CD8 response

  Days 0,28,90 and 180

Study Arms (1)

MTBVAC

EXPERIMENTAL

30 healthy, BCG vaccinated, HIV negative, adults, aged 18 - 65 years, in whom LTB Infection has been excluded by negative QuantiFERON® (QFT) Gold-Plus assay.

Biological: Tuberculosis Vaccine

Interventions

Tuberculosis Vaccine BIOLOGICAL

1. Live, attenuated Mycobacterium tuberculosis (M. tb)- MTBVAC (MTBVAC)01 strain 2. 3-17x105CFU (Per dose) Sucrose Sodium glutamate 3. Lyophilized pellet in vials (10doses) 4. 0.1 mL/dose (After reconstitution with 1 mL/vial sterilized water for injection)

MTBVAC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent.\[Audio video consent for vulnerable subjects\]
• Participants of either gender of age between ≥18 to ≤65years.
• Only QFT negative participants will be included
• Good general health as determined by the discretion of the investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and \<140 mm Hg; diastolic ≥ 60 mm Hg and \<90 mm Hg; oral temperature \<100.4ºF), medical history, and physical examination).
• Expressed interest and availability to fulfill the study requirements.
• For a female participant of childbearing potential, planning to avoid pregnancy (use of an effective method of contraception or abstinence) from the time of study enrolment until at least 3 months after IP administration.
• Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from IP administration until 3 months.
• No evidence of active TB disease during screening - Normal chest radiograph and no bacteriological positivity by Genexpert plus test of sputum for M. tb
• Clinically acceptable laboratory values for blood tests and a negative pregnancy test (for childbearing-age women)
• Seronegative for human immunodeficiency virus 1 and -2 (HIV- 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies.
• Had BCG vaccination at Birth, documented through medical history or presence of scar.

You may not qualify if:

• Any chronic febrile illness with oral temperature \> 100°F on the day of enrollment.
• Evidence of pulmonary pathology as confirmed by chest X-ray.
• History of any form of TB Disease.
• Prior or present anti-TB treatment
• Received Tuberculin Skin Test (TST) within 3 months (90 days) prior to Study Day 0.
• Clinical evidence of Active TB
• Subjects with house hold contacts of Active TB
• History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations (any vaccine).
• QFT Plus positive subjects.
• History of allergic disease or reactions.
• History of previous administration of experimental Mycobacterium tuberculosis vaccines.
• Use of any investigational or non-registered product (drug or vaccine) in another experimental protocol other than the trial vaccines within 30 days preceding the vaccination, or planned use during the trial period.
• Any chronic drug therapy to be continued during the trial period.
• Chronic administration of immune suppressors or other immune- modifying drugs.
• Administration of any immunoglobulins, any immunotherapy, and/or any blood products within the three months preceding the vaccination, or planned administrations during the trial period.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (1)

NIMS, Hyderabad

Hyderabad, Telangana, 500082, India

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Tuberculosis Vaccines

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Dr.V.Krishna Mohan, PhD

  Bharat Biotech International Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: June 3, 2024
• Study Start: January 19, 2024
• Primary Completion: January 29, 2024
• Study Completion: July 27, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)