Preventive Immunization COVID-19Phase 1/2NCT04437875
An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" Vaccine Against COVID-19
A Phase 1/2 study testing Gam-COVID-Vac Lyo in people with Preventive Immunization COVID-19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial summary
the purpose of this study: to evaluate the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", a lyofilizate for preparing solution for intramuscular administration, at various times after vaccination in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Preventive Immunization COVID-19
- What is being tested?
- Gam-COVID-Vac Lyo
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteRussia
- Study dates
- 17 Jun 2020to 10 Aug 2020
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males and females within the age range from 18 to 60 years;
- written informed consent;
- subject body mass index (BMI): 18.5 ≤ BMI ≤ 30;
- negative PCR test results for SARS-CoV-2 (during the screening);
- no history of COVID-2019 disease;
- no contacts of volunteers with patients with COVID-2019 for at least 14 days;
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- negative test results for IgM and IgG antibodies to SARS-CoV-2;
- subject agrees to use effective contraceptive methods during the entire period of participation in the study;
- absence of acute infectious diseases at the time of vaccine administration and 14 days before vaccination;
- negative pregnancy test of blood or urine (for women of childbearing age);
- subject has negative tests for HIV, hepatitis B and С, syphilis or confirmed medical history;
- subject has a negative result of the urine test for residual narcotic drugs;
- negative test for alcohol in exhaled air;
- the absence of malignant diseases of any nature and localization;
- in medical history and based on the screening results, subject has no diseases or pathologies of the gastrointestinal system, liver, kidneys, cardiovascular system and blood, CNS, musculoskeletal system, urogenital, immune and endocrine systems that from the point of view of the researcher and/or of the organizer of the study, may affect the safety of the volunteer and the evaluation of the study results (clinical, instrumental and laboratory tests did not reveal diseases or clinically significant deviations)
Who cannot join
- volunteer involvement in another study over the last 90 days;
- any vaccination over the last 30 days;
- history of COVID-2019 disease;
- positive PCR test results for SARS-CoV-2 (during the screening);
- positive test results for IgM and IgG antibodies to SARS-CoV-2;
- health staff in contact with people with COVID-2019;
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- respiratory symptoms in the last 14 days;
- the administration of immunoglobulins or other blood products in the last 3 months;
- regular current or past use of narcotic drugs;
- subject has received immunosuppressive and/or immunomodulating agents within 6 months before the start of the study;
- pregnancy or breast feeding;
- exacerbation of allergic diseases at the time of vaccination;
- subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg; diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower than 60 beats per minute or above 100 beats per minute;
- a burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, a history of serum sickness, hypersensitivity or allergic reactions to the introduction of any vaccines in history, known allergic reactions to vaccine components, etc.);
- a history of autoimmune diseases in the volunteer's medical history and in relatives' medical history of the 1-2 degree of kinship;
- subject smokes more than 10 cigarettes per day;
- alcohol intake exceeding the low-risk level: no more than 20 grams of pure alcohol per day, no more than 5 days a week, alcohol intake within 48 hours before the administration of the drug;
- planned hospitalization and/or surgery during the period of participation in the study, as well as 4 weeks before the expected date of the administration of the drug;
- the presence of an associated disease that may affect the assessment of the results of the study;
- any conditions that, according to the researcher's doctor, may be a contraindication to the participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac Lyo" Lyophilizate for the Preparation of a Solution for Intramuscular Injection With the Participation of Healthy Volunteers
the purpose of this study: to evaluate the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", a lyofilizate for preparing solution for intramuscular administration, at various times after vaccination in healthy adult volunteers.
Read the detailed description
An open two stage non-randomized Phase 1 study with the participation of healthy volunteers. This clinical trial is an open study of safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, with the participation of healthy volunteers.
Study objectives
- A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, using single dose of each component (Stage 1).
- A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2).
Study Design Stage 1 the First group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 1 in a full therapeutic dose.
the Second group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 2 in the full therapeutic dose.
The studied drugs will be administered to a total of 18 volunteers in a hospital setting and after administration, the drug's safety will be continuously monitored for 5 days. Based on the results of the safety assessment, the Chief investigator decides to proceed to the second stage of the study on the 5th day after the introduction of the studied drugs.
Second stage The second stage will include 20 volunteers and three understudies. Volunteers of the second stage will be vaccinated no earlier than 5 days after vaccination of participants of the first stage.
Volunteers participating in the second stage of the study (a total of 20 people) will receive the study drug according to the booster scheme: the introduction of component 1 will be carried out on day 1, and component 2-on the 21st day of the study. Follow-up will be carried out during 4 visits: on 7, 14, 28, 42 days after administration of the drug.
Throughout the inpatient observation and the follow-up period (180 days) of visits during the entire study, safety information will be collected
- Conditions
- Preventive Immunization COVID-19
- Being tested
- Gam-COVID-Vac Lyo
- Keywords
- COVID-19, SARS-CoV-2, vector vaccine, adenovirus vector
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gam-COVID-Vac LyoBiological
adenoviral-based vaccine against SARS-CoV-2
| Study group | Role | What they receive |
|---|---|---|
| Component 1 | Experimental | rAd26 Component, 1 vaccination Component 1 consists of a recombinant adenovirus vector based on the human adenovirus type 26, containing the SARS-CoV-2 S protein gene. Receives: Biological: Gam-COVID-Vac Lyo |
| Component 2 | Experimental | rAd5 Component, 1 vaccination Component 2 consists of a vector based on the human adenovirus type 5, containing the SARS-CoV-2 S protein gene. Receives: Biological: Gam-COVID-Vac Lyo |
| Prime-Boost Immunization | Experimental | Day 1 rAd26 Component Day 21 rAd5 Component Receives: Biological: Gam-COVID-Vac Lyo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changing of antibody levels against the SARS-CoV-2 glycoprotein S at 42 days
Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Measured: at days 0, 14, 21, 28, 42
Number of Participants With Adverse Events
Determination of Number of Participants With Adverse Events
Measured: through the whole study, an average of 180 days
Secondary outcomes (2)
The changing of virus neutralizing antibody titer
Determination of virus neutralizing antibody titer
Measured: at days 0, 14, 28, 42
The changing of antigen-specific cellular immunity level
Determination of antigen-specific cellular immunity (specific T-cell immunity, in particular, IFN-gamma production or lymphoproliferation)
Measured: at days 0, 14, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start17 Jun 2020
- Primary completion3 Aug 2020
- Study completion10 Aug 2020
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 Preventive Immunization COVID-19Studies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An open, prospective, two-stage, non-randomized, first-phase study involving healthy volunteers
- Masking
- None (open label)
- Enrolment
- 38 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
- Collaborators
- Acellena Contract Drug Research and Development
- Responsible party
- Sponsor
- Investigators
- Lola Morozova, Md, Principal investigator, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437875
- Sponsor's protocol ID
- 03-Gam-COVID-Vac Lyo-2020
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020 Sep 26;396(10255):887-897. doi: 10.1016/S0140-6736(20)31866-3. Epub 2020 Sep 4.
PubMed 32896291
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac Lyo" Lyophilizate for the Preparation of a Solution for Intramuscular Injection With the Participation of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04437875
- Acronym / sponsor ID
- 03-Gam-COVID-Vac Lyo-2020
- Conditions
- Preventive Immunization COVID-19
- Keywords
- COVID-19, SARS-CoV-2, vector vaccine, adenovirus vector
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- Acellena Contract Drug Research and Development
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 18 Jun 2020 (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 purpose of this study: to evaluate the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", a lyofilizate for preparing solution for intramuscular administration, at various times after vaccination in healthy adult volunteers.
Detailed description
An open two stage non-randomized Phase 1 study with the participation of healthy volunteers. This clinical trial is an open study of safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, with the participation of healthy volunteers.
Study objectives
- A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, using single dose of each component (Stage 1).
- A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2).
Study Design Stage 1 the First group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 1 in a full therapeutic dose.
the Second group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 2 in the full therapeutic dose.
The studied drugs will be administered to a total of 18 volunteers in a hospital setting and after administration, the drug's safety will be continuously monitored for 5 days. Based on the results of the safety assessment, the Chief investigator decides to proceed to the second stage of the study on the 5th day after the introduction of the studied drugs.
Second stage The second stage will include 20 volunteers and three understudies. Volunteers of the second stage will be vaccinated no earlier than 5 days after vaccination of participants of the first stage.
Volunteers participating in the second stage of the study (a total of 20 people) will receive the study drug according to the booster scheme: the introduction of component 1 will be carried out on day 1, and component 2-on the 21st day of the study. Follow-up will be carried out during 4 visits: on 7, 14, 28, 42 days after administration of the drug.
Throughout the inpatient observation and the follow-up period (180 days) of visits during the entire study, safety information will be collected
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- An open, prospective, two-stage, non-randomized, first-phase study involving healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| Component 1 | Experimental | Biological: Gam-COVID-Vac LyorAd26 Component, 1 vaccination Component 1 consists of a recombinant adenovirus vector based on the human adenovirus type 26, containing the SARS-CoV-2 S protein gene. |
| Component 2 | Experimental | Biological: Gam-COVID-Vac LyorAd5 Component, 1 vaccination Component 2 consists of a vector based on the human adenovirus type 5, containing the SARS-CoV-2 S protein gene. |
| Prime-Boost Immunization | Experimental | Biological: Gam-COVID-Vac LyoDay 1 rAd26 Component Day 21 rAd5 Component |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- males and females within the age range from 18 to 60 years;
- written informed consent;
- subject body mass index (BMI): 18.5 ≤ BMI ≤ 30;
- negative PCR test results for SARS-CoV-2 (during the screening);
- no history of COVID-2019 disease;
Key exclusion criteria (20 listed)
- volunteer involvement in another study over the last 90 days;
- any vaccination over the last 30 days;
- history of COVID-2019 disease;
- positive PCR test results for SARS-CoV-2 (during the screening);
- positive test results for IgM and IgG antibodies to SARS-CoV-2;
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 |
|---|---|---|
| Gam-COVID-Vac Lyoadenoviral-based vaccine against SARS-CoV-2 | Biological | Component 1, Component 2, Prime-Boost Immunization |
Primary outcome
The changing of antibody levels against the SARS-CoV-2 glycoprotein S at 42 days
Time frame: at days 0, 14, 21, 28, 42
Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Number of Participants With Adverse Events
Time frame: through the whole study, an average of 180 days
Determination of Number of Participants With Adverse Events
2 secondary outcomes
The changing of virus neutralizing antibody titer
Time frame: at days 0, 14, 28, 42
The changing of antigen-specific cellular immunity level
Time frame: at days 0, 14, 28
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 12 Aug 2020.
- Derived from this study: PubMed 32896291Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020 Sep 26;396(10255):887-897. doi: 10.1016/S0140-6736(20)31866-3. Epub 2020 Sep 4.
- 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.
Lola Morozova, Md principal investigator
I.M. Sechenov First Moscow State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gam-COVID-Vac Lyo in people with Preventive Immunization COVID-19, 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 15 inclusion and 20 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 12 Aug 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
The changing of antibody levels against the SARS-CoV-2 glycoprotein S at 42 days (time frame: at days 0, 14, 21, 28, 42). 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 NCT04437875, 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 12 Aug 2020.