Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis.

National Research Center for Epidemiology and Microbiology

Status and phase: Completed; Phase 1

Conditions: Tuberculosis

Treatments: Biological: Double GamTBvac vaccination (0.5 dose); Biological: Placebo administration; Biological: Double GamTBvac vaccination (0.25 dose); Biological: Double GamTBvac vaccination (1.0 dose); Biological: Single GamTBvac vaccination (0.25 dose)

Study type: Interventional

Funder types: Other

Identifiers

NCT03255278

GamTBvac Ph1

Details and patient eligibility

About

The study is aimed to evaluate the safety and immunogenicity of the medicinal product "GamTBvac" - a recombinant subunit vaccine against the tuberculosis. The study is designed as a comparative placebo-controlled study with a two-fold increase of an applied dose among healthy volunteers aged 18-49 years.

Full description

The clinical trial study of the "GamTBvac" vaccine against the tuberculosis is a comparative placebo-controlled study with a two-fold increase of an applied dose among healthy volunteers aged 18-49 years. The product "GamTBvac" is a lyophilized substance consisted of the purified recombinant subunit antigens of Mycobacterium tuberculosis, that is applied for the preparing of the solution for a subcutaneous administration. Currently the study is at the first phase.

The aims of the study are: a) to confirm the safety of the product in the healthy volunteers; b) to select the optimal administration dose; c) to evaluate of the immunogenicity of the vaccine; d) to investigate the immune cell memory as a response to the vaccination.

The total number of the volunteers in the study is 60:

1. at the first stage to estimate the safety and portable of the vaccine, two groups of volunteers each includes 12 persons got the single decreased dose (0.25 of the planned dose for regular administration) of the vaccine (the first group, 12 persons), and the 0.5 ml of the placebo (the second group, 12 persons);
2. at the second stage to select the optimal dose and the scheme of the vaccine administration, additionally three groups, each consist of 12 persons of volunteers will be recruited. The first group will get double vaccination of a decreased dose (0.25 of the regular dose), the second group will get the double vaccination of a mean dose (0.5 of the regular dose), and the third one will get the double vaccination of the maximum (1.0 regular) dose.

The inclusion criteria for the volunteers of the study are: healthy males either females aged 18-49 years who have previously got the BCG vaccine. The exclusion criterion is the presence of the latent tuberculosis in the patient that is confirmed during the preliminary laboratory screening.

Enrollment: 60 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• lack of the latent tuberculosis, laboratory confirmed
• BCG vaccination in the past
• signed informed consent

Exclusion criteria

• presence of the latent tuberculosis, laboratory confirmed

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 5 patient groups, including a placebo group

Safety and portable study group

Experimental group

Description:

12 persons who have got a single decreased dose (0.25 of the planned dose for regular administration) of the GamTBvac recombinant subunit vaccine. The intervention for the Arm: single GamTBvac vaccination (0.25 dose).

Treatment:

Biological: Single GamTBvac vaccination (0.25 dose)

Placebo safety study group

Placebo Comparator group

Description:

12 persons who have got a single dose of placebo (0.5 ml). The intervention for the Arm: Placebo administration (0.5 ml)

Treatment:

Biological: Placebo administration

Immunogenicity study group #1

Experimental group

Description:

12 persons who will get a double sequential administration of the decreased dose (0.25 of the planned dose for regular applying) of the GamTBvac recombinant subunit vaccine. The intervention for the Arm: double GamTBvac vaccination (0.25 dose).

Treatment:

Biological: Double GamTBvac vaccination (0.25 dose)

Immunogenicity study group #2

Experimental group

Description:

12 persons who will get a double sequential administration of the mean dose (0.5 of the planned dose for regular applying) of the GamTBvac recombinant subunit vaccine. The intervention for the Arm: double GamTBvac vaccination (0.5 dose).

Treatment:

Biological: Double GamTBvac vaccination (0.5 dose)

Immunogenicity study group #3

Experimental group

Description:

12 persons who will get a double sequential administration of the maximum (regular) dose of the GamTBvac recombinant subunit vaccine. The intervention for the Arm: double GamTBvac vaccination (1.0 dose).

Treatment:

Biological: Double GamTBvac vaccination (1.0 dose)