Covid19Phase 3SPUTNIK-UAENCT04656613
A Phase III Clinical Trial of the Immunogenicity and Safety of the Gam-COVID-Vac Vaccine Against COVID-19 in the UAE
A Phase 3 study testing Gam-COVID-Vac in people with Covid19 and SARS-CoV Infection, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Trial summary
This study is randomized, double-blind (blinded for the trial subject and the study physician), placebo-controlled trial in the parallel assignment of the immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Gam-COVID-Vac
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agree to sign the study informed consent form (ICF) before performing any study-specific procedure.
- Adults, i.e., ≥ 18 years old.
- Negative HIV, hepatitis B, hepatitis C, and syphilis test results
- Negative IgM and IgG SARS CoV2 antibodies enzyme immunoassay test result.
- Negative COVID-19 RT-PCR test result at the screening visit.
- No COVID-19 in medical history.
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- Subjects to confirm they had no contact with COVID-19 persons within at least 14 days before the screening visit.
- Consent for using effective methods of contraception during the entire trial1
- A negative urine pregnancy test at the screening visit (for child-bearing age women).
- Negative alcohol test at the screening visit.
- No evidence of vaccine-induced reactions or complications after receiving immunobiological products in medical history.
- No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.
Who cannot join
- Any vaccination/immunization within 30 days before the enrollment.
- History of COVID-19.
- Positive SARS-CoV-2 screening result obtained by PCR (at screening).
- Test results for IgM and IgG antibodies to SARS-CoV-2 is positive.
- Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment.
- Pregnancy or breast-feeding.
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- Acute coronary syndrome or stroke suffered less than one year before the enrollment.
- Tuberculosis, chronic systemic infections in medical history.
- Drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study vaccine components, acute exacerbation of allergic diseases on the enrollment day.
- Known allergic reactions to vaccination
- History of asthma
- Neoplasms in medical history.
- Major operations in the past 12 months before study vaccine administration. This will include but not limited to; major organs transplant, bone marrow donation, etc.
- Splenectomy in the past medical history
- Neutropenia (absolute neutrophil count <1,000 mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the medical history within 6 months before the enrollment.
- Any family member with immunodeficiency, cancer, or transplantation
- The active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C.
- Subjects with diabetes, heart disease, chronic kidney disease, or dialysis
- Subjects with latent tuberculosis infection
- Anorexia, protein deficiency of any origin.
- Subjects with any metabolic diseases
- Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine/placebo administration.
- Alcohol or drug addiction in medical history.
- Participation in any other interventional clinical trial within the previous 90 days (from the administration of the Vaccine).
- Any other condition that the study physician considers as a barrier to the trial completion as per the protocol.
- Healthcare workers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase III, Randomized, Double -Blind, Placebo-controlled Trial to Evaluate Immunogenicity and Safety of the Gam-COVID-Vac Combined Vector Vaccine in Prophylactic Treatment for SARS-СoV-2 Infection in the United Arab Emirates
This study is randomized, double-blind (blinded for the trial subject and the study physician), placebo-controlled trial in the parallel assignment of the immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Read the detailed description
The subjects will be randomized into two groups in the ratio of 1:3; a reference group of 250 subjects receiving placebo and a study group of 750 subjects receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection. The trial subjects will be randomized into five age strata: 18-30, 31-40, 41- 50, 51-60, and 60+ years. Each subject will participate in the trial for 180±14 days after the first dose of the study vaccine/placebo and will have in total six on-site visits to the study physician during the study period and several follow-ups Phone Call/ Teleconsultation during the study as follow:
- One Screening visit, i.e., Screening Visit = Day -7 to Day -1
- Two vaccination visits, i.e.,
- Visit 1 / Day1
- Tele-consultation / Phone Call to start on Day 2 and a weekly basis until visit 2
- Visit 2/ Day 21±2 Days
- Tele-consultation / Phone Call to occur on Day 22±2 Days then on a weekly basis until visit 3.
- Four Observational Visits to be scheduled as follow:
- Visit 3/ Day 28 ±2 days
- Weekly Follow Up Tele-consultation / Phone calls until visit 4
- Visit 4/ Day 42 ±4 days
- Weekly Follow Up Tele-consultation / Phone Call until visit 5
- Visit 5/ Day 90 ±7 days
- Weekly Follow Up Tele-consultation / Phone Call until visit 6
- Visit 6/ Day 120 ±14 days
- Weekly Follow Up Tele-consultation / Phone calls until visit 7
- End of Study Visit/ Visit 7/ Day 180 ± 14 days The study vaccine/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 1 and day 21±2). Subsequent observation visits 3, 4, 5, 6 and end of study visit / EOS /Visit 7 will be made on days 28±2, 42±4, 90±7, 120±14 and D180±14 respectively. During the observation visits, vitals will be assessed in all trial subjects, and changes in the subjects' condition and wellbeing compared to the previous visit will be recorded. Blood samples will be collected per the schedule of assessment from all subjects during the following visits to assess the following immunogenicity parameters.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Gam-COVID-Vac, placebo
- Keywords
- vector, covid-19, adenoviral vector vaccine, Sputnik V
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gam-COVID-VacBiological
Also called Sputnik V
the Gam-COVID-Vac is combined 2 -component vector vaccine against the SARS-СoV-2-induced coronavirus infection
placeboOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | a study group of 750 subjects receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection Receives: Biological: Gam-COVID-Vac |
| Placebo | Placebo comparator | a reference group of 250 subjects receiving placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 glycoprotein-specific antibodies titer
The geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 , 120±14 and 180±14 days after the first dose
Measured: 42±4 , 120±14 and 180±14 days
Seroconversion rate
Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4, 120±14 and 180±14 days after the first dose
Measured: 42±4, 120±14 and 180±14 days
IFN-gamma antigen-specific release
Interferon gamma concentration in response to S protein after re-stimulation with the SARS-CoV-2 glycoprotein in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose
Measured: 28±4 days
CD4+/CD8+ proliferating cells
The number of proliferating CD4 and CD8 cells in response to antigen stimulation in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose
Measured: 28±4 days
Virus-neutralizing antibodies titer
Geometric mean virus-neutralizing antibodies titer in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 and 120±14 days after the first dose
Measured: 42±4 and 120±14 days
Secondary outcomes (1)
Incidence and severity of adverse events
Incidence and severity of adverse events in trial subjects within 4 \& 6 months after injecting the first dose of the study vaccine/placebo.
Measured: within 4 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,000 participants (estimated)
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
- PDC-CRO
- Responsible party
- Sponsor
- Investigators
- Mohamed Mostafa, Study director, PDC-CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656613
- Sponsor's protocol ID
- 06-Gam-COVID-Vac-2020
- Acronym
- SPUTNIK-UAE
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double -Blind, Placebo-controlled Trial to Evaluate Immunogenicity and Safety of the Gam-COVID-Vac Combined Vector Vaccine in Prophylactic Treatment for SARS-СoV-2 Infection in the United Arab Emirates
- ClinicalTrials.gov ID
- NCT04656613
- Acronym / sponsor ID
- SPUTNIK-UAE / 06-Gam-COVID-Vac-2020
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- vector, covid-19, adenoviral vector vaccine, Sputnik V
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- PDC-CRO
- Study start
- Dec 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Dec 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.
This study is randomized, double-blind (blinded for the trial subject and the study physician), placebo-controlled trial in the parallel assignment of the immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Detailed description
The subjects will be randomized into two groups in the ratio of 1:3; a reference group of 250 subjects receiving placebo and a study group of 750 subjects receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection. The trial subjects will be randomized into five age strata: 18-30, 31-40, 41- 50, 51-60, and 60+ years. Each subject will participate in the trial for 180±14 days after the first dose of the study vaccine/placebo and will have in total six on-site visits to the study physician during the study period and several follow-ups Phone Call/ Teleconsultation during the study as follow:
- One Screening visit, i.e., Screening Visit = Day -7 to Day -1
- Two vaccination visits, i.e.,
- Visit 1 / Day1
- Tele-consultation / Phone Call to start on Day 2 and a weekly basis until visit 2
- Visit 2/ Day 21±2 Days
- Tele-consultation / Phone Call to occur on Day 22±2 Days then on a weekly basis until visit 3.
- Four Observational Visits to be scheduled as follow:
- Visit 3/ Day 28 ±2 days
- Weekly Follow Up Tele-consultation / Phone calls until visit 4
- Visit 4/ Day 42 ±4 days
- Weekly Follow Up Tele-consultation / Phone Call until visit 5
- Visit 5/ Day 90 ±7 days
- Weekly Follow Up Tele-consultation / Phone Call until visit 6
- Visit 6/ Day 120 ±14 days
- Weekly Follow Up Tele-consultation / Phone calls until visit 7
- End of Study Visit/ Visit 7/ Day 180 ± 14 days The study vaccine/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 1 and day 21±2). Subsequent observation visits 3, 4, 5, 6 and end of study visit / EOS /Visit 7 will be made on days 28±2, 42±4, 90±7, 120±14 and D180±14 respectively. During the observation visits, vitals will be assessed in all trial subjects, and changes in the subjects' condition and wellbeing compared to the previous visit will be recorded. Blood samples will be collected per the schedule of assessment from all subjects during the following visits to assess the following immunogenicity parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: Gam-COVID-Vaca study group of 750 subjects receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection |
| Placebo | Placebo comparator | Other: placeboa reference group of 250 subjects receiving placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Agree to sign the study informed consent form (ICF) before performing any study-specific procedure.
- Adults, i.e., ≥ 18 years old.
- Negative HIV, hepatitis B, hepatitis C, and syphilis test results
- Negative IgM and IgG SARS CoV2 antibodies enzyme immunoassay test result.
- Negative COVID-19 RT-PCR test result at the screening visit.
Key exclusion criteria (26 listed)
- Any vaccination/immunization within 30 days before the enrollment.
- History of COVID-19.
- Positive SARS-CoV-2 screening result obtained by PCR (at screening).
- Test results for IgM and IgG antibodies to SARS-CoV-2 is positive.
- Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment.
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-VacAlso: Sputnik Vthe Gam-COVID-Vac is combined 2 -component vector vaccine against the SARS-СoV-2-induced coronavirus infection | Biological | Vaccine |
| placeboPlacebo Comparator | Other | Placebo |
Primary outcome
SARS-CoV-2 glycoprotein-specific antibodies titer
Time frame: 42±4 , 120±14 and 180±14 days
The geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 , 120±14 and 180±14 days after the first dose
Seroconversion rate
Time frame: 42±4, 120±14 and 180±14 days
Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4, 120±14 and 180±14 days after the first dose
IFN-gamma antigen-specific release
Time frame: 28±4 days
Interferon gamma concentration in response to S protein after re-stimulation with the SARS-CoV-2 glycoprotein in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose
CD4+/CD8+ proliferating cells
Time frame: 28±4 days
The number of proliferating CD4 and CD8 cells in response to antigen stimulation in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose
Virus-neutralizing antibodies titer
Time frame: 42±4 and 120±14 days
Geometric mean virus-neutralizing antibodies titer in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 and 120±14 days after the first dose
1 secondary outcome
Incidence and severity of adverse events
Time frame: within 4 & 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- 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.
Mohamed Mostafa study director
PDC-CRO
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gam-COVID-Vac in people with Covid19 and SARS-CoV Infection, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
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 12 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mostafa (+971555389246, Mohamed.Mostafa@pdc-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 glycoprotein-specific antibodies titer (time frame: 42±4 , 120±14 and 180±14 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2020.