Preventive Immunization COVID-19 Clinical Trial
Official title:
An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac" a Solution for Intramuscular Injection With the Participation of Healthy Volunteers
The purpose of the study is to assess safety, tolerability and immunogenicity of the drug
"Gam-COVID-Vac ", a solution for intramuscular administration, with the participation of
healthy volunteers
Study objectives A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution
for intramuscular administration, using single dose of each component (Stage 1).
A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular
administration, using prime-boost immunization according to the proposed scheme (Stage 2).
Post-vaccination immunity assessment at different time points after vaccination by:
- Determination of antigen-specific antibody titer in blood serum by ELISA by comparison
with baseline values before the vaccine administration and at days 14, 21, 28, and 42
after vaccination (hereinafter, the countdown comes from the first time of the vaccine
administration);
- Determination of virus neutralizing antibody titer before and at days 14, 28, and 42
after vaccination;
- Determination of antigen-specific cellular immunity (specific T-cell immunity) before
the vaccine administration and at days 14 and 28 after vaccination.
An open two stage non-randomized Phase 1 study with the participation of healthy volunteers.
This clinical trial is an open study of safety, tolerability and immunogenicity of the drug
"Gam-COVID-Vac ", ly solution for intramuscular administration, with the participation of
healthy volunteers.
Stage one
1. the First group, 9 volunteers, will receive the drug, a solution for intramuscular
administration, in the mode of single immunization with component 1 in a full
therapeutic dose.
2. the Second group, 9 volunteers, will receive the drug, a solution for intramuscular
administration, in the mode of single immunization with component 2 in the full
therapeutic dose.
The studied drugs will be administered to a total of 18 volunteers in a hospital setting and
after administration, the drug's safety will be continuously monitored for 5 days. Based on
the results of the safety assessment, the Chief investigator decides to proceed to the second
stage of the study on the 5th day after the introduction of the studied drugs.
Second stage The second stage will include 20 volunteers and three understudies. Volunteers
of the second stage will be vaccinated no earlier than 5 days after vaccination of
participants of the first stage.
Volunteers participating in the second stage of the study (a total of 20 people) will receive
the study drug according to the booster scheme: the introduction of component 1 will be
carried out on day 1, and component 2-on the 21st day of the study. Follow-up will be carried
out during 4 visits: on 7, 14, 28, 42 days after administration of the drug, and phone calls
at days 90 and 180
Throughout the inpatient observation and the follow-up period of visits during the entire
study, safety information will be collected
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04437875 -
An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" Vaccine Against COVID-19
|
Phase 1/Phase 2 |