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

NCT03255278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-12-27

No results posted yet for this study

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

Interventions

BIOLOGICAL

Single GamTBvac vaccination (0.25 dose)

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

BIOLOGICAL

Placebo administration

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

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.

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.

BIOLOGICAL

Double GamTBvac vaccination (1.0 dose)

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-15
Primary Completion
2017-12-13
Completion
2017-12-13

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03255278 on ClinicalTrials.gov