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

Tuberculosis Clinical Trial

— GamTBvac  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255278
• Other study ID #: GamTBvac Ph1
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2017
• Last updated: December 25, 2017
• Start date: January 15, 2017
• Est. completion date: December 13, 2017

Study information

• Verified date: August 2017
• Source: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 13, 2017
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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 administration
Single administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2).
• Double GamTBvac vaccination (0.25 dose)
Double sequential administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the immunogenicity.
• Double GamTBvac vaccination (0.5 dose)
Double sequential administration of the mean dose of vaccine (0.5 of regular dose) to evaluate the immunogenicity.
• Double GamTBvac vaccination (1.0 dose)
Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity.

Locations

Country	Name	City	State
Russian Federation	Sechenov First Moscow State Medical University	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Tkachuk AP, Gushchin VA, Potapov VD, Demidenko AV, Lunin VG, Gintsburg AL. Multi-subunit BCG booster vaccine GamTBvac: Assessment of immunogenicity and protective efficacy in murine and guinea pig TB models. PLoS One. 2017 Apr 28;12(4):e0176784. doi: 10.1371/journal.pone.0176784. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and severity of adverse effects	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.	140 Days
Secondary	immunogenicity control	Qualitative ELISA test for specific IgG antibodies, study of the stimulated T-cell	140 Days

External Links

•   Tkachuk AP, Gushchin VA, Potapov VD, Demidenko AV, Lunin VG, Gintsburg AL. Multi-subunit BCG booster vaccine GamTBvac: Assessment of immunogenicity and protective efficacy in murine and guinea pig TB models. PLoS One. 2017 Apr 28