Study of the Vector Vaccine GamCovidVac for the Prevention of COVID-19 With Altered Antigenic Profile With Participation of Adult Volunteers

October 4, 2023 updated by: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Safety, Reactogenicity and Immunogenicity Study of the Vector Vaccine GamCovidVac for the Prevention of Coronavirus (COVID-19) Infection Caused by the SARS-CoV-2 Virus With Altered Antigenic Profile With Participation of Adult Volunteers

Safety, reactogenicity and immunogenicity study of the vector vaccine GamCovidVac for the prevention of coronavirus (COVID-19) infection caused by the SARS-CoV-2 virus with altered antigenic profile with participation of adult volunteers

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The study will include volunteers who meet all the specified criteria:

  1. Written informed consents to participate in the Study;
  2. Adult volunteers men and women over 18 years old;
  3. A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP);
  4. Consent to the use of effective methods of contraception during the entire period of participation in the Study;
  5. A negative pregnancy test based on the results of a urine test at a screening visit (for women with preserved reproductive potential);
  6. Negative test for the presence of narcotic and psychostimulants in the urine at the screening visit;
  7. Negative alcohol content test at the screening visit;
  8. Any vaccination not earlier than the last 30 days before inclusion in the Study;
  9. No contraindications to vaccination;
  10. Absence of acute infectious and/or respiratory diseases for at least 14 days prior to inclusion in the Study.

Exclusion Criteria:

Volunteers cannot be included in the Study if there is at least one of the following criteria for non-inclusion:

  1. No written informed consents to participate in the Study
  2. Therapy with steroids (with the exception of hormonal contraceptives and/or hormone replacement therapy) and / or immunoglobulins or other blood products that did not end 30 days before inclusion in the Study;
  3. Therapy with any immunosuppressive drugs completed less than 3 months prior to inclusion in the Study;
  4. Female volunteers during pregnancy or lactation;
  5. Acute coronary syndrome or stroke suffered less than one year prior to inclusion in the Study;
  6. Tuberculosis, chronic systemic infections (according to anamnesis);
  7. Burdened allergic anamnesis (record of anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness in the anamnesis), hypersensitivity or allergic reactions to the administration of immunobiological drugs, known allergic reactions to any of the components of the vaccine or vaccine containing similar components, exacerbation of allergic diseases on the day of inclusion in the Study;
  8. The presence of neoplasms (ICD codes C00-D09) (according to anamnesis);
  9. Splenectomy (according to the anamnesis);
  10. Neutropenia (decrease in the absolute number of neutrophils less than 1000 cells / mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin concentration less than 80 g/l) - 6 month prior to inclusion in the Study (according to the anamnesis);
  11. Volunteers with an active form of the disease caused by the human immunodeficiency virus, syphilis, hepatitis B and C (according to the anamnesis);
  12. Anorexia, protein deficiency of any origin;
  13. Alcoholism and drug addiction (according to the anamnesis);
  14. Participation in any other clinical trial 90 days prior to the screening;
  15. Extensive tattoos at the injection sites (deltoid muscle area), which do not allow to assess the local reaction to the introduction of investigational medicinal product (IMP);
  16. Any other condition of the volunteer of the Study, which, in the opinion of the research physician, may prevent the completion of the study in accordance with the protocol;
  17. Vaccination against COVID-19 or transmitted coronavirus infection (COVID-19) less than 6 months prior to the screening;
  18. Multiple administration of the Sputnik V vaccine, Sputnik Lite, or multiple administration of any other COVID-19 vaccine for more than three injections (Sputnik V vaccination plus Sputnik Lite revaccination);
  19. Inability to read in Russian; inability or unwillingness to understand the essence of the Study;
  20. Any other conditions that limit the validity of obtaining informed consent or may affect the ability of a volunteer to participate in the Study.
  21. Staff of research centers (chief researcher and members of the research team) directly involved in the research and their family members.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Healthy patients
Drug: GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile); A total of 50 people will be randomized and receive the study drug (vaccine). Two intramuscular injections of the investigational medicinal product (IMP) will be performed. 1st injection - component I, 2nd injection - component II.
Biological: GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile)
Two intramuscular injections of the GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile) will be performed. 1st injection - component I, 2nd injection - component II.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of adverse events (AE)
Time Frame: Within 28 days after administration of the drug
Occurrence of adverse events (AE)
Within 28 days after administration of the drug
Occurrence of serious adverse events (SAEs)
Time Frame: Throughout Study completion, until December 2024
Occurrence of serious adverse events (SAEs)
Throughout Study completion, until December 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12-GamCovidVac/N-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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