TuberculosisPhase 1GamTBvacNCT03255278
Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis.
A Phase 1 study testing Single GamTBvac vaccination (0.25 dose), Double GamTBvac vaccination (0.25 dose) and Double GamTBvac vaccination (0.5 dose) in people with Tuberculosis, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Single GamTBvac vaccination (0.25 dose), Double GamTBvac vaccination (0.25 dose) and Double GamTBvac vaccination (0.5 dose)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2017to 13 Dec 2017
- Phase
- Phase 1
- 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
- lack of the latent tuberculosis, laboratory confirmed
- BCG vaccination in the past
- signed informed consent
Who cannot join
- presence of the latent tuberculosis, laboratory confirmed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis. Comparative Placebo-controlled Study With a Two-fold Increase of the Vaccine Dose in Healthy Volunteers Aged 18-49 Years.
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.
Read the detailed description
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 volunteers aged 18-49 years. The product "GamTBvac" is a lyophilized substance consisted of the purified recombinant subunit antigens of Mycobacterium tuberculosis, that is applied for the preparing of the solution for a subcutaneous administration. Currently the study is at the first phase.
The aims of the study are: a) to confirm the safety of the product in the healthy volunteers; b) to select the optimal administration dose; c) to evaluate of the immunogenicity of the vaccine; d) to investigate the immune cell memory as a response to the vaccination.
The total number of the volunteers in the study is 60:
- at the first stage to estimate the safety and portable of the vaccine, two groups of volunteers each includes 12 persons got the single decreased dose (0.25 of the planned dose for regular administration) of the vaccine (the first group, 12 persons), and the 0.5 ml of the placebo (the second group, 12 persons);
- at the second stage to select the optimal dose and the scheme of the vaccine administration, additionally three groups, each consist of 12 persons of volunteers will be recruited. The first group will get double vaccination of a decreased dose (0.25 of the regular dose), the second group will get the double vaccination of a mean dose (0.5 of the regular dose), and the third one will get the double vaccination of the maximum (1.0 regular) dose.
The inclusion criteria for the volunteers of the study are: healthy males either females aged 18-49 years who have previously got the BCG vaccine. The exclusion criterion is the presence of the latent tuberculosis in the patient that is confirmed during the preliminary laboratory screening.
- Conditions
- Tuberculosis
- Being tested
- Single GamTBvac vaccination (0.25 dose), Placebo administration, Double GamTBvac vaccination (0.25 dose), Double GamTBvac vaccination (0.5 dose), Double GamTBvac vaccination (1.0 dose)
- Keywords
- Tuberculosis, Recombinant vaccine, Mycobacterium tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single GamTBvac vaccination (0.25 dose)Biological
Single administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the safety.
Placebo administrationBiological
Single administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2).
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.
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.
Double GamTBvac vaccination (1.0 dose)Biological
Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: 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). Receives: 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). Receives: 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). Receives: Biological: Double GamTBvac vaccination (1.0 dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 140 Days
Secondary outcomes (1)
immunogenicity control
Qualitative ELISA test for specific IgG antibodies, study of the stimulated T-cell
Measured: 140 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start15 Jan 2017
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255278
- Sponsor's protocol ID
- GamTBvac Ph1
- Acronym
- GamTBvac
- Status last verified
- Aug 2017
- First submitted
- 29 Jun 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28453555
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis. Comparative Placebo-controlled Study With a Two-fold Increase of the Vaccine Dose in Healthy Volunteers Aged 18-49 Years.
- ClinicalTrials.gov ID
- NCT03255278
- Acronym / sponsor ID
- GamTBvac / GamTBvac Ph1
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Recombinant vaccine, Mycobacterium tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 volunteers aged 18-49 years. The product "GamTBvac" is a lyophilized substance consisted of the purified recombinant subunit antigens of Mycobacterium tuberculosis, that is applied for the preparing of the solution for a subcutaneous administration. Currently the study is at the first phase.
The aims of the study are: a) to confirm the safety of the product in the healthy volunteers; b) to select the optimal administration dose; c) to evaluate of the immunogenicity of the vaccine; d) to investigate the immune cell memory as a response to the vaccination.
The total number of the volunteers in the study is 60:
- at the first stage to estimate the safety and portable of the vaccine, two groups of volunteers each includes 12 persons got the single decreased dose (0.25 of the planned dose for regular administration) of the vaccine (the first group, 12 persons), and the 0.5 ml of the placebo (the second group, 12 persons);
- at the second stage to select the optimal dose and the scheme of the vaccine administration, additionally three groups, each consist of 12 persons of volunteers will be recruited. The first group will get double vaccination of a decreased dose (0.25 of the regular dose), the second group will get the double vaccination of a mean dose (0.5 of the regular dose), and the third one will get the double vaccination of the maximum (1.0 regular) dose.
The inclusion criteria for the volunteers of the study are: healthy males either females aged 18-49 years who have previously got the BCG vaccine. The exclusion criterion is the presence of the latent tuberculosis in the patient that is confirmed during the preliminary laboratory screening.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Safety and portable study group | Experimental | Biological: Single GamTBvac vaccination (0.25 dose)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). |
| Placebo safety study group | Placebo comparator | Biological: Placebo administration12 persons who have got a single dose of placebo (0.5 ml). The intervention for the Arm: Placebo administration (0.5 ml) |
| Immunogenicity study group #1 | Experimental | Biological: Double GamTBvac vaccination (0.25 dose)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). |
| Immunogenicity study group #2 | Experimental | Biological: Double GamTBvac vaccination (0.5 dose)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). |
| Immunogenicity study group #3 | Experimental | Biological: Double GamTBvac vaccination (1.0 dose)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). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- lack of the latent tuberculosis, laboratory confirmed
- BCG vaccination in the past
- signed informed consent
Key exclusion criteria (1 listed)
- presence of the latent tuberculosis, laboratory confirmed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single GamTBvac vaccination (0.25 dose)Single administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the safety. | Biological | Safety and portable study group |
| Placebo administrationSingle administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2). | Biological | Placebo safety study group |
| 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 | Immunogenicity study group #1 |
| 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 | Immunogenicity study group #2 |
| Double GamTBvac vaccination (1.0 dose)Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity. | Biological | Immunogenicity study group #3 |
Primary outcome
The number and severity of adverse effects
Time frame: 140 Days
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.
1 secondary outcome
immunogenicity control
Time frame: 140 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Background: PubMed 28453555Tkachuk 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.
- 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 28Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single GamTBvac vaccination (0.25 dose), Double GamTBvac vaccination (0.25 dose) and Double GamTBvac vaccination (0.5 dose) in people with Tuberculosis, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site 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 3 inclusion and 1 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 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The number and severity of adverse effects (time frame: 140 Days). 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 NCT03255278, which also lists 1 linked publication.
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 27 Dec 2017.