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

NCT03878004 | Completed Phase 2

• 1 other identifier: 01-GamTBvac-2018
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Tuberculosis; Mycobacterium tuberculosis; Recombinant vaccine; Mycobacterium Infections; Vaccines

Outcome Measures

Primary Outcomes (2)

• level of IFN-y secretion in whole blood or PBMC fraction

  1\. Secretion level of IFN-y by whole blood or PBMC fraction in response to stimulation with vaccine antigens

  Day 0 through month 5

• Number of Participants With Adverse Events

  Determining the frequency of an undesirable immediate response response within 2 hours after vaccine administration; assessment of the frequency of local and systemic requests for the entire observation period after the 1-st vaccination and the 2-nd vaccination

  Day 1 - month 5

Secondary Outcomes (3)

• CD4+ and CD8+ T cells

  Day 0 through month 5

• titer of antibodies of the IgG class

  Day 0 - month 5

• QuantiFERON TB

  Day 0, month 5

Study Arms (2)

Primary Group

EXPERIMENTAL

135 people who will receive the vaccine in the therapeutic scheme

Biological: GamTBvac vaccine

Placebo Group

PLACEBO COMPARATOR

45 people who will receive placebo in the therapeutic scheme

Biological: placebo

Interventions

GamTBvac vaccine BIOLOGICAL

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

Primary Group

placebo BIOLOGICAL

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

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Ability to understand the study requirements, sign the Informed Consent Form (ICF) and consent to all restrictions applicable during the study.
• Participants must be 18 to 49 years of age inclusive, at the time of signing the informed consent.
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination and laboratory tests.
• No evidence of pulmonary pathology as confirmed by chest X-ray.
• Body Mass Index (BMI) 18 to 30 kg/m2, inclusive.
• Male and female.
• For female participants: a female participant is eligible to participate if she is not pregnant (has a negative pregnancy test (dipstrip) at screening and at Study Day 0), not breastfeeding, and at least one of the following conditions applies: a) Not a women of childbearing potential (WOCBP) OR b) A WOCBP who agrees to follow the contraceptive guidance during the full duration of the study.
• Had BCG vaccination, documented through medical history or presence of scar.
• Positive result of PPD-L test: induration 5 mm and 9 mm.
• The absence of markers of the immune response to mycobacterial proteins ESAT6 and CFP10, which characterize the probable contact with M. tuberculosis preceding the beginning of the study in Diaskintest and QuantiFERON TB Gold ELISA tests at the same time on screening.
• The absence of the fact of living or working with someone who has a diagnosis of tuberculosis for 3 months before Day 0 of the study.
• The absence of malignant neoplasms at the moment and for 5 years before being included in the study.
• The absence of malignant blood diseases.

You may not qualify if:

• The presence of symptoms of acute illness, including the temperature in the axillary cavity of more than 37.5 C, for 5 days before the start of the study and on day 0 of the study.
• Anamnesis or the presence of tuberculosis, including extrapulmonary tuberculosis.
• Negative result of PPD-L test ( less than 5 mm) or hyperergic positive PPD-L test (more than 9 mm).
• The presence of a positive or doubtful result in the tests Diaskintest and / or QuantiFERON TB Gold ELISA.
• Anamnesis or the presence of autoimmune diseases or immunosuppression, or a family history of congenital or hereditary immunodeficiency.
• Positive tests for the presence of HIV-1/2 antibodies, HBsAg or hepatitis C antibodies on screening.
• Use of immunosuppressive or other immunomodulatory drugs for 42 days before Day 0 of the study.
• Use of immunoglobulin or blood products for 180 days prior to Day 0 of the study or a plan for their appointment during the study.
• Use of any study drug or vaccine under study for 90 days prior to the day of screening, or planned participation in other clinical studies during the study.
• Use of antibacterial drugs within 14 days prior to Day 0 of the study (oral administration) or within 28 days before Day 0 of the study (parenteral administration).
• Use the tested GamTBvac at any time before day 0 of the study.
• Planned use / prescription of a registered vaccine within 28 days before and 28 days after vaccination with the vaccine in question.
• Planned surgery (in a planned manner) during the study.
• Anamnesis or presence according to laboratory data of any possible immunodeficiency state.
• A history of allergic diseases or reactions that may be aggravated by any component of the vaccine in question.

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead
• contract research organization Cromos Pharma: collaborator
• contract research organization K-Research: collaborator

Study Sites (2)

"City polyclinic № 2 Of the Department of health of the city of Moscow", Выделите текст, чтобы посмотреть примеры

Moscow, 117556, Russia

Location

Sechenov University

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Tuberculosis; Mycobacterium Infections

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: December 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: May 31, 2020
• Last Updated: June 17, 2020

Record last verified: 2019-03

Locations

RU (2)