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

NCT06068569 | Unknown Phase 3

• 1 other identifier: 12-GamCovidVac/N-2023
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Healthy patients

EXPERIMENTAL

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)

Interventions

GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile) BIOLOGICAL

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.

Healthy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will include volunteers who meet all the specified criteria:
• Written informed consents to participate in the Study;
• Adult volunteers men and women over 18 years old;
• A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP);
• Consent to the use of effective methods of contraception during the entire period of participation in the Study;
• A negative pregnancy test based on the results of a urine test at a screening visit (for women with preserved reproductive potential);
• Negative test for the presence of narcotic and psychostimulants in the urine at the screening visit;
• Negative alcohol content test at the screening visit;
• No contraindications to vaccination;

You may not qualify if:

• No written informed consents to participate in the Study
• Female volunteers during pregnancy or lactation;
• Tuberculosis, chronic systemic infections (according to anamnesis);
• The presence of neoplasms (ICD codes C00-D09) (according to anamnesis);
• Splenectomy (according to the anamnesis);
• Volunteers with an active form of the disease caused by the human immunodeficiency virus, syphilis, hepatitis B and C (according to the anamnesis);
• Anorexia, protein deficiency of any origin;
• Alcoholism and drug addiction (according to the anamnesis);
• Participation in any other clinical trial 90 days prior to the screening;
• 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);
• 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;
• Vaccination against COVID-19 or transmitted coronavirus infection (COVID-19) less than 6 months prior to the screening;
• 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);
• Inability to read in Russian; inability or unwillingness to understand the essence of the Study;
• Any other conditions that limit the validity of obtaining informed consent or may affect the ability of a volunteer to participate in the Study.

Sponsors & Collaborators

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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 5, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-09