The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older
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|ClinicalTrials.gov Identifier: NCT04587219|
Recruitment Status : Unknown
Verified October 2020 by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Recruitment status was: Active, not recruiting
First Posted : October 14, 2020
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infection||Biological: Gam-COVID-Vac||Phase 2|
An open-ended prospective non-randomized study involving volunteers over the age of 60.
The study will include 110 volunteers. who will receive the test drug according to the prime-boost scheme: the introduction of component 1 will be carried out on the 1st day, and component 2 - on the 21st day of the study. Outpatient monitoring will be performed during 4 visits: on the 7th, 14th, 28th, and 42nd days after the vaccine administration Also two visits will be performed in the phone contact mode for 90 and 180 days
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open prospective non-randomized study|
|Masking:||None (Open Label)|
|Official Title:||An Open Study of the Safety, Tolerability and Immunogenicity of the "Gam-COVID-Vac"Vaccine Against COVID-19 (Solution for Intramuscular Injection) With the Participation of Volunteers in the Age Group Over 60 Years|
|Actual Study Start Date :||October 22, 2020|
|Estimated Primary Completion Date :||March 30, 2021|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: Gam COVID Vac Vaccine
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.
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)
- Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days [ Time Frame: at days 0, 21, 28, 42 ]Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
- Number of Participants With Adverse Events [ Time Frame: through the whole study, an average of 180 days ]Determination of Number of Participants With Adverse Events
- Changing of of virus neutralizing antibody titer [ Time Frame: at days 0, 28, 42 ]Determination of virus neutralizing antibody titer
- Changing of antigen-specific cellular immunity level [ Time Frame: Time Frame: at days 0,28 ]Determination of antigen-specific cellular immunity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587219
|Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation|
|Moscow, Russian Federation|
|Principal Investigator:||Nikita Lomakin, MD, PhD||Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation|