Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac

NCT04975737 | Unknown Phase 3

• 1 other identifier: 02-GamTBvac-2020
• Study Type: interventional
• Target: 7,180
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, double-blind, randomized (in 1:1 ratio) placebo-controlled study to assess the safety and protective efficacy of the subunit recombinant tuberculosis vaccine GamTBvac against the development of respiratory tuberculosis not associated with HIV infection in volunteers aged 18-45 years.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Preventive efficacy (Ep)

  Preventive efficacy calculated as Ep=(1-RR)∗100%, where RR is the relative risk of developing pulmonary tuberculosis in the vaccine group compared to placebo

  24 months after vaccination

Study Arms (2)

Vaccine Group

EXPERIMENTAL

3590 volunteers who will receive 1 dose (0.5 ml) of the vaccine GamTBvac administered twice with an 8-week interval between administrations.

Biological: GamTBvac

Placebo group

PLACEBO COMPARATOR

3590 volunteers who will receive 1 dose (0.5 ml) of the placebo administered subcutaneously twice with an 8-week interval between administrations.

Biological: Placebo

Interventions

GamTBvac BIOLOGICAL

The subunit recombinant tuberculosis vaccine GamTBvac (lyophilisate for preparation of solution for subcutaneous administration, 5.35 mg / dose)

Vaccine Group

Placebo BIOLOGICAL

Placebo for subcutaneous administration

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female volunteers aged 18-45 years (inclusive);
• Volunteers from population groups with a high incidence of tuberculosis (more than 30 people per 100 thousand population);
• Absence of active tuberculosis, confirmed by chest x-ray or computed tomography;
• Body mass index 18.5 - 30 kg / m2 (inclusive) according to Quetelet's weight and height index;
• Signed informed consent to participate in the study in accordance with the current legislation;
• Previous bacille Calmette Guerin (BCG) vaccination according to medical history or confirmed by the presence of a scar;
• Absence of markers of the immune response to mycobacterial proteins ESAT6 and CFP10, which characterize the probable contact with M. tuberculosis prior to the start of the study confirmed by the tuberculosis skin test;
• Negative pregnancy test in female volunteers with preserved reproductive potential at screening and on the day of the first vaccination;
• Consent of male and female participants with preserved reproductive potential to observe an adequate method of contraception (double barrier method: male or female condom and combined hormonal contraceptive (oral, vaginal and transdermal forms can be used) or using a condom or diaphragm with spermicide during the entire period of vaccination and 1 month after completion of vaccination Exception: surgically sterile (more than 6 months) or postmenopausal (more than 12 months);
• Consent of male participants not to participate in sperm donation during the entire period of vaccination and 1 month after completion of vaccination.
• Positive test results for HIV-1/2 antibodies, HBsAg or hepatitis C antibodies at screening;
• History of extrapulmonary tuberculosis;
• History of chronic non-infectious respiratory disease, including idiopathic pulmonary fibrosis (IPF), bronchial asthma, chronic obstructive pulmonary disease (COPD), or pulmonary hypertension.
• Clinically significant ECG abnormalities at screening;
• Aggravated allergic history (bronchial asthma, history of anaphylaxis reactions);

You may not qualify if:

• Participation of a volunteer in the study may be terminated for the following reasons:
• Development of primary tuberculosis of the respiratory system;
• The researcher decided that the volunteer should be excluded in the interests of the volunteer himself;
• The volunteer has a serious adverse event related to the study vaccine;
• Failure to comply with the rules of participation in the study;
• The participant refuses to cooperate or is undisciplined;
• Development of any other significant adverse events;
• Deterioration of the volunteer's health.

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead

Study Sites (1)

City hospital #40

Saint Petersburg, 197706, Russia

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Maria Semashko

CONTACT

+7 (499) 193-30-01; info@gamaleya.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 23, 2021
• Study Start: January 20, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

RU (1)