The Phase 1/2 trial will include 110 volunteers that will be administered the study drug. Outpatient observation will be done over the course of 4 visits: on days 10, 28, and 42 following drug administration Along with that, the study will be continued in accordance with the Protocol, accompanied by all the prescribed procedures and visits up to 180 days of observation.
Any volunteer who received a dose of the study drug will be registered as a trial participant, and his/her data will be used to help assess the drug's safety and tolerability.
This Phase I/II study of the Safety and Immunogenicity of Sputnik Light vaccine has demonstrated that:
Sputnik Light can elicit the development of antigen-specific IgG antibodies in 96.9% of individuals on the 28th day after vaccination;
The Sputnik Light vaccine elicits the development of virus-neutralizing antibodies in 91.67% of individuals on the 28th day post-immunization;
Cellular immune response against the S Protein of SARS-CoV-2 develops in 100% of volunteers on the 10th day;
The immunization of individuals with pre-existing immunity against SARS-CoV-2 with Sputnik Light can elicit the increase of the level of antigen specific IgG antibodies by more than 40x in 100% of subjects 10 days after immunization;
No serious adverse events were registered after vaccination with Sputnik Light.