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HealthyPhase 2NCT03878004

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

A Phase 2 study testing GamTBvac vaccine in people with Healthy, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 2 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
GamTBvac vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
2 sitesRussia
Study dates
1 Dec 2018to 31 May 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • The medical history of diseases that may endanger the safety of the participant, including but not limited to: deterioration of lung function in any lung disease, heart or kidney failure, neurological diseases, epilepsy or infant convulsions, diabetes, cancer.
  • Anamnesis or the presence of any systemic diseases or any chronic diseases that, in the opinion of the researcher, may affect the safety assessment or the reactogenicity or immunogenicity of the vaccine under investigation.
  • Anamnesis of chronic abuse of alcohol or drugs.
  • Anamnesis or the presence of diseases or features of the skin, which, according to the researcher, may affect the evaluation of reactions at the injection site (diseases: malignant skin, allergic and eczematous skin diseases; features: congenital or acquired benign lesions on the skin (nevus) , scars, decorative modifications of the body (applying a permanent (resistant) pattern, tattoos) applied drawings).
  • Volunteer participation in any other clinical study over the past 90 days.
  • Donor blood donation (450 ml or more of blood or plasma) less than 2 months prior to inclusion in the study.
  • The presence of allergic reactions to animal proteins and a tuberculin allergen in history.

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

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

    Moscow, 117556

  • Sechenov University

    Moscow, 119991

Other trials in Russia

About this study

Official title: A Double-blind, Randomized, Multicentre, Placebo-controlled Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac in Healthy Adults

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.

Read the detailed description

Participants will be randomized in two groups (in 3:1 ratio -vaccine : placebo) to receive two doses of either GamTBvac or placebo. Subjects will be followed for 5 months after dose 1.

The primary goal of this study is to assess the immunogenicity of a tuberculosis subunit recombinant GamTBvac vaccine in a vaccination scheme with double administration to healthy volunteers.

The secondary goal of this study is the in-depth assessment of the safety and reactogenicity of the tuberculosis subunit recombinant vaccine GamTBvac when given twice to healthy volunteers.

Conditions
Healthy
Being tested
GamTBvac vaccine, placebo
Keywords
Tuberculosis, Mycobacterium tuberculosis, Recombinant vaccine, Mycobacterium Infections, Vaccines
Medical subject headings
Tuberculosis, Mycobacterium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GamTBvac vaccineBiological

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

  • placeboBiological

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

Study groups in NCT03878004
Study groupRoleWhat they receive
Primary GroupExperimental135 people who will receive the vaccine in the therapeutic scheme
Receives: Biological: GamTBvac vaccine
Placebo GroupPlacebo comparator45 people who will receive placebo in the therapeutic scheme
Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 0 through month 5

  2. 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

    Measured: Day 1 - month 5

Secondary outcomes (3)

  1. CD4+ and CD8+ T cells

    Percentage of CD4+ and CD8+ T cells that express IFN-y, TNF, and/or IL-2 alone or in combination in response to stimulation with vaccine antigens (representing the full sequence of the vaccine antigens or its separate domains)

    Measured: Day 0 through month 5

  2. titer of antibodies of the IgG class

    A change in the titer of antibodies of the IgG class (induction of the humoral response) to the complete sequence of vaccine antigens or their individual domains, determined using multiplex suspension enzyme immunoassay timeline.

    Measured: Day 0 - month 5

  3. QuantiFERON TB

    A positive result in the quantum test using the QuantiFERON TB Gold ELISA reagent kit.

    Measured: Day 0, month 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start1 Dec 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03878004
Sponsor's protocol ID
01-GamTBvac-2018
Status last verified
Mar 2019
First submitted
14 Mar 2019
Last updated
17 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GamTBvac vaccine in people with Healthy, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

level of IFN-y secretion in whole blood or PBMC fraction (time frame: Day 0 through month 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03878004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.

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