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NCT Number: NCT03255278

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

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.

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Key information

Conditions

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

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sechenov First Moscow State Medical University

Moscow, 119435, Russia

About this study

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:

  • 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);
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single GamTBvac vaccination (0.25 dose)

Biological

Single administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the safety.

Placebo administration

Biological

Single administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2).

Double GamTBvac vaccination (0.25 dose)

Biological

Double sequential administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the immunogenicity.

Double GamTBvac vaccination (0.5 dose)

Biological

Double sequential administration of the mean dose of vaccine (0.5 of regular dose) to evaluate the immunogenicity.

Double GamTBvac vaccination (1.0 dose)

Biological

Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity.

Primary outcomes

  1. The number and severity of adverse effects

    Time frame: 140 Days

    Safety control: an active periodical examination of the health status of volunteers, including vital indicators, instrumental tests (ECG), laboratory blood and urine analysis (general and biochemistry). The presence, nature and severity of local and systemic reactions in different groups of volunteers, depending on the dose of vaccination, will be taken into account.

Secondary outcomes

  1. immunogenicity control

    Time frame: 140 Days

    Qualitative ELISA test for specific IgG antibodies, study of the stimulated T-cell

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis. Comparative Placebo-controlled Study With a Two-fold Increase of the Vaccine Dose in Healthy Volunteers Aged 18-49 Years.

Acronym: GamTBvac

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 21, 2017
Registry last updated
Dec 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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