The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older

NCT04587219 | Unknown Phase 2

• 1 other identifier: 05-Gam-COVID-Vac-2020
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age

Conditions

Coronavirus Infection

Keywords

COVID-19; vaccine; vector vaccine; Immunologic Factors; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days

  Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values

  at days 0, 21, 28, 42

• Number of Participants With Adverse Events

  Determination of Number of Participants With Adverse Events

  through the whole study, an average of 180 days

Secondary Outcomes (2)

• Changing of of virus neutralizing antibody titer

  at days 0, 28, 42

• Changing of antigen-specific cellular immunity level

  Time Frame: at days 0,28

Study Arms (1)

Gam COVID Vac Vaccine

EXPERIMENTAL

the test drug will be administered according to the prime-boost scheme: the introduction of component 1 (Ad26) will be carried out on the 1st day, and component 2(Ad5)- on the 21st day of the study.

Biological: Gam-COVID-Vac

Interventions

Gam-COVID-Vac BIOLOGICAL

combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S)

Gam COVID Vac Vaccine

Eligibility Criteria

• Age: 60 Years - 111 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The written informed consent of the subject for participation in the study;
• Men and women over the age of 60 years inclusive;
• Negative result of research on HIV, hepatitis, syphilis;
• negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay;
• negative test result for COVID-2019, determined by PCR at the screening session;
• The absence of a history COVID-2019;
• Consent to use effective methods of contraception during the entire period of participation in the study;
• A negative test for the presence of narcotic and psychoactive agents in urine at the screening visit;
• A negative test for alcohol at screening visit;
• negative pregnancy test (performed for women with preserved reproductive potential)
• No history of severe postvaccinal reactions or postvaccinal complications after the use of immunobiological drugs;

You may not qualify if:

• Subjects of the female gender during pregnancy or breastfeeding;
• Tuberculosis, chronic systemic infections;
• the presence of a history of neoplasms (ICD codes C00-D09);
• Splenectomy in history;
• Subjects with an active form of the disease caused by the human immunodeficiency virus, syphilis, hepatitis B and C;
• Anorexia, protein deficiency of any origin;
• extensive tattoos at the sites of drug administration (deltoid muscle area), which do not allow to assess the local response to the introduction of ILP;
• Alcoholism and drug addiction in history;
• Consists on the account at the psychiatrist;
• subject's participation in any other interventional clinical trial within 90 days prior to the start of this study;
• any other condition of the research subject that, in the opinion of the research doctor, may prevent the completion of the study in accordance with The Protocol;
• staff of research centers and other employees directly involved in the research (members of the research team) and their families.
• severe comorbid diseases that, in the opinion of the research doctor, may prevent participation in the study.

Sponsors & Collaborators

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

Study Sites (1)

Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation

Moscow, Russia

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Gam-COVID-Vac vaccine

Condition Hierarchy (Ancestors)

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

Study Officials

• Nikita Lomakin, MD, PhD

  Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open prospective non-randomized study

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 14, 2020
• Study Start: October 22, 2020
• Primary Completion: March 30, 2021
• Study Completion: April 30, 2021
• Last Updated: January 22, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)