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Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac

NCT03878004 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-06-17

No results posted yet for this study

Summary

This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study to assess the safety, reactogenicity and immunogenicity in healthy, BCG vaccinated adults.

Conditions

  • Healthy

Interventions

BIOLOGICAL

GamTBvac vaccine

introduction of GamTBvac (lyophilisate for preparation of solution for subcutaneous administration, 5.35 mg / dose) twice into a shoulder with an 8-week interval.

BIOLOGICAL

placebo

introduction of placebo twice into a shoulder with an 8-week interval.

Sponsors & Collaborators

  • contract research organization Cromos Pharma

    collaborator UNKNOWN

  • contract research organization K-Research

    collaborator UNKNOWN

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-12-31
Completion
2020-05-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

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 NCT03878004 on ClinicalTrials.gov