Study of the Vector Vaccine GamCovidVac for the Prevention of COVID-19 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

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: Not yet recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events (AE)	Occurrence of adverse events (AE)	Within 28 days after administration of the drug
Occurrence of serious adverse events (SAEs)	Occurrence of serious adverse events (SAEs)	Throughout Study completion, until December 2024

Collaborators and Investigators

• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID 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