Study of the Vector Vaccine GamCovidVac-M (Altered Antigenic Composition)

NCT06068556 | Unknown Phase 3

• 1 other identifier: 13-GamCovidVac-M/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-M for the prevention of coronavirus (COVID-19) infection caused by the SARS-CoV-2 virus with altered antigenic composition with participation of 12-17 years old volunteers.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Occurrence of adverse events (AE)

  Occurrence of adverse events (AE)

  Within 7 days after each administration of the drug

• Occurrence of serious adverse events (SAEs)

  Occurrence of serious adverse events (SAEs)

  Through study completion, an average of 1 year

Study Arms (1)

Healthy patients

EXPERIMENTAL

Drug: GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition. A total of 50 people will be randomized and receive the study drug. Two intramuscular injections of GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition will be performed. 1st injection - component I, 2nd injection - component II.

Biological: GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition

Interventions

GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition BIOLOGICAL

Two intramuscular injections of GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition will be performed. 1st injection - component I, 2nd injection - component II.

Healthy patients

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The study will include volunteers who meet all the specified criteria:
• Written informed consents to participate in the study, obtained from: the volunteer, his/her parent or a legal guardian;
• years old teenagers (men and women);
• A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP);
• No COVID-19 during 6 months prior to the screening (according to the anamnesis);
• 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;

You may not qualify if:

• Any immunodeficiency (for example, hereditary immunodeficiency, acquired immunodeficiency syndrome \[AIDS\], etc.);
• Infectious diseases (according to the anamnesis): history of HIV, hepatitis, active form of syphilis at the time of screening; Tuberculosis; Active infection (with the exception of onychomycosis), or any acute infection episode requiring treatment with antibiotics intravenously for 4 weeks prior to screening or orally for 2 weeks prior to screening; History (according to the anamnesis) of serious recurrent or chronic infection, not listed above;
• Extensive surgery within 4 weeks prior to screening;
• Chronic autoimmune diseases or systemic collagenoses (according to the anamnesis), requiring the prescription of immunosuppressive therapy;
• Volunteers who have undergone organ transplantation, including bone-marrow transplantation or peripheral blood stem cell transplantation and receive immunosuppressive therapy;
• Splenectomy (according to the anamnesis);
• Volunteers with a previous or concomitant history of neoplasms (ICD codes C00-D09);
• 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), thrombocytopenia (decrease in the absolute number of platelets less than 50,000 cells/ mm3);
• Anorexia, protein deficiency of any origin;
• Volunteers with a BMI value in the range from -2 SD to +2 SD, according to their age;
• 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);
• Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, muscle and connective tissue in the stage of exacerbation or decompensation;
• Presence of mental abnormalities (registered as psychiatrist's/narcologist's patient);
• Diseases, the presence of which, from the point of view of the research doctor, puts the participant's health at risk in case of participation in the Study or potentially complicates the interpretation of the results of the examination;
• Family members of the staff of research centers directly involved in the research;

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 22, 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