AzTrials
AzTrials

Covid19Phase 3VENEZUELANCT04642339

Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela

A Phase 3 study testing Gam-COVID-Vac in people with Covid19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Randomized, double-blind, placebo controlled clinical trial of immunogenicity, safety and efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19
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
2,000 participants
Where
No sites listed yet
Study dates
Nov 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

  • Written informed consent of a subject to participate in the trial
  • Males and females aged 18+
  • Negative HIV, hepatitis, and syphilis test results
  • A negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay
  • A negative test result for COVID-2019 by PCR at screening visit
  • No COVID-2019 in the medical history
Show all 13Show fewer
  • No contact with COVID-2019 persons within at least 14 days before the enrollment (according to trial subjects)
  • Consent to use effective contraception methods during the trial
  • Negative urine pregnancy test at the screening visit (for child-bearing age women)
  • Negative drugs or psychostimulants urine test at the screening visit
  • Negative alcohol test at the screening visit
  • No evident vaccine-induced reactions or complications after receiving immunobiological products in the 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;
  • Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment.
  • Immunosuppressors therapy finished within 3 months before the enrollment
  • Pregnancy or breast-feeding
  • Acute coronary syndrome or stroke suffered less than one year before the enrollment
  • Tuberculosis, chronic systemic infections
Show all 18Show fewer
  • 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 drug components, acute exacerbation of allergic diseases on the enrollment day
  • Neoplasms in the medical history.
  • Donated blood or plasma (450+ ml) within 2 months before the enrollment
  • Splenectomy in the 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
  • Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C
  • Anorexia, protein deficiency of any origin
  • Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration
  • Alcohol or drug addiction in the medical history
  • Participation in any other interventional clinical trial.
  • Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
  • Study center staff and other employees directly involved in the trial and their families.

Trial locations and contacts

No sites are listed yet.

Alexis H García Piñero, MD contact

+582122191711

alexisgarcia27@gmail.com

Children's Cardiology Hospital "Dr. Gilberto Rodriguez Ochoa" contact

+582122191711

presidencia@espromedbio.gob.ve

About this study

Official title: Randomized, Double-blind, Placebo Controlled, Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Combined Vector Vaccine in Prophylactic Treatment for SARS-СoV-2 Infection

Randomized, double-blind, placebo controlled clinical trial of immunogenicity, safety and efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults.

Read the detailed description

Randomized, double-blind (blinded for trial subject and the study physician), placebo controlled clinical trial in parallel assignment of the immunogenicity, safety, and efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults.

The trial will include 2,000 volunteers over the age of 18. After screening, they will be randomised (3:1) into two groups - a reference group of 500 volunteers who will receive the placebo and a study group of 1,500 volunteers who will receive the combined Gam-COVID-Vac vaccine against SARS-induced coronavirus infection-СoV-2oV-2. 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 drug/placebo and will have one screening visit and five on-site visits to the study physician during the said period. The study drug/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 1 and day 21±2). Follow-up visits Nos. 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14, respectively. Blood samples will be taken from certain subjects during the following visits to assess the immunogenicity parameters on days 1, 42±2 and 180±14. During observation visits, vital indicators will be assessed on all trial subjects and changes in the subjects' condition and well-being will be recorded, observational visits may be remote, using telemedicine (TM) technologies. Additionally, the trial subjects will be able to have remote consultations with the study physician through the TM. Data from trial subjects will be collected through electronic case report forms.

Conditions
Covid19
Being tested
Gam-COVID-Vac, Placebo
Keywords
vaccine, COVID-19, adenoviral vector, SARS-CoV-2, Ad26, Ad5, Heterologous prime-boost vaccination
Medical subject headings
COVID-19, Alzheimer Disease 5

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

    Gam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization with component I (rAd26-S) and component II (rAd5-S) with 21 days interval

  • PlaceboBiological

    Placebo

Study groups in NCT04642339
Study groupRoleWhat they receive
Vaccine Gam-COVID-VacExperimentalGam-COVID-Vac combined vector vaccine against the SARS-CoV-2 infection
Receives: Biological: Gam-COVID-Vac
PlaceboPlacebo comparatorPlacebo
Receives: Biological: Placebo

What is being measured

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

  1. Seroconversion rate

    Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose

    Measured: 42 day, 180 day

Secondary outcomes (4)

  1. Incidence and severity of adverse events

    Incidence and severity of adverse events in trial subjects within 6 months after injecting the first dose of the study drug/placebo

    Measured: through the study (till day 180)

  2. Virus-neutralizing antibody levels against the SARS-CoV-2

    Geometric mean virus-neutralizing antibodies titer in 500 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose

    Measured: 42 day

  3. Antibody levels against the SARS-CoV-2 glycoprotein

    Geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose

    Measured: 42 day, 180 day

  4. Percentage of trial subjects with coronavirus disease 2019 (COVID-19)

    Percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months, as confirmed with the method of polymerase chain reaction (PCR)

    Measured: through the study (till day 180)

Timeline

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

  1. First posted24 Nov 2020
  2. Study startNov 2020 (estimated)
  3. Primary completionOct 2021 (estimated)
  4. Study completionDec 2021 (estimated)

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04642339
Sponsor's protocol ID
01V-Gam-COVID-Vac-2020
Acronym
VENEZUELA
Status last verified
Nov 2020
First submitted
16 Nov 2020
Last updated
24 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Franco C, Cornejo A, Rodriguez M, Garcia A, Belisario I, Mayora S, Garzaro DJ, Jaspe RC, Hidalgo M, Parra N, Liprandi F, Zambrano JL, Rangel HR, Pujol FH. Sputnik V-Induced Antibodies against SARS-CoV-2 Variants during the Dissemination of the Gamma Variant in Venezuela. Viruses. 2024 Sep 18;16(9):1480. doi: 10.3390/v16091480.

    PubMed 39339956

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gam-COVID-Vac in people with Covid19, 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 13 inclusion and 18 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 24 Nov 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 Alexis H García Piñero, MD (+582122191711, alexisgarcia27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate (time frame: 42 day, 180 day). 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 NCT04642339, 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 24 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in