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

NCT03255278 | Completed Phase 1

• 1 other identifier: GamTBvac Ph1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; Recombinant vaccine; Mycobacterium tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• immunogenicity control

  140 Days

Study Arms (5)

Safety and portable study group

EXPERIMENTAL

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)

Placebo safety study group

PLACEBO COMPARATOR

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

Immunogenicity study group #1

EXPERIMENTAL

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)

Immunogenicity study group #2

EXPERIMENTAL

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)

Immunogenicity study group #3

EXPERIMENTAL

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)

Interventions

Single GamTBvac vaccination (0.25 dose) BIOLOGICAL

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

Safety and portable study group

Placebo administration BIOLOGICAL

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

Placebo safety study group

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.

Immunogenicity study group #1

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.

Immunogenicity study group #2

Double GamTBvac vaccination (1.0 dose) BIOLOGICAL

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

Immunogenicity study group #3

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• presence of the latent tuberculosis, laboratory confirmed

Sponsors & Collaborators

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

Study Sites (1)

Sechenov First Moscow State Medical University

Moscow, 119435, Russia

Location

Related 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.

  PMID: 28453555 BACKGROUND

Related 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

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: August 21, 2017
• Study Start: January 15, 2017
• Primary Completion: December 13, 2017
• Study Completion: December 13, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)