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

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ClinicalTrials.gov Identifier: NCT03255278
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: Single GamTBvac vaccination (0.25 dose) Biological: Placebo administration Biological: Double GamTBvac vaccination (0.25 dose) Biological: Double GamTBvac vaccination (0.5 dose) Biological: Double GamTBvac vaccination (1.0 dose) Phase 1

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model 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 volonteers aged 18-49 years.
Masking: Single (Participant)
Primary Purpose: Prevention
Official 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.
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : December 13, 2017
Actual Study Completion Date : December 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: Safety and portable study group

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).

Biological: Single GamTBvac vaccination (0.25 dose)
Single administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the safety.

Placebo Comparator: Placebo safety study group
12 persons who have got a single dose of placebo (0.5 ml). The intervention for the Arm: Placebo administration (0.5 ml)
Biological: Placebo administration
Single administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2).

Experimental: Immunogenicity study group #1

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).

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

Experimental: Immunogenicity study group #2

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).

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

Experimental: Immunogenicity study group #3

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).

Biological: Double GamTBvac vaccination (1.0 dose)
Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity.




Primary Outcome Measures :
  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 Outcome Measures :
  1. immunogenicity control [ Time Frame: 140 Days ]
    Qualitative ELISA test for specific IgG antibodies, study of the stimulated T-cell



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255278


Locations
Russian Federation
Sechenov First Moscow State Medical University
Moscow, Russian Federation, 119435
Sponsors and Collaborators
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Additional Information:
Publications:
Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
ClinicalTrials.gov Identifier: NCT03255278     History of Changes
Other Study ID Numbers: GamTBvac Ph1
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation:
Tuberculosis
Recombinant vaccine
Mycobacterium tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs