NCT04713488

An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine

An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" t Vaccine for Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Viruso

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 111 Years
• Healthy volunteers: Accepted

Summary

Phase I-II open prospective, two-stage, non-randomized study in healthy volunteers.

Detailed description

Screening Period = up to 7 days All screening procedures must be executed within the shortest possible time frame before the scheduled date for Visit 1 (drug administration). The laboratory and instrumental examination data obtained within 14 days before the screening will be recorded as the screening data. The trial will include 110 volunteers that will be administered the study drug. Outpatient observation will be done over the course of 4 visits: on day 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. Visit No. 0 (outpatient): screening Visit No. 1 (outpatient): vaccination Visits No. 2, 3, 4, 5, and 8: follow-up on days 10, 28, 42, 90, and180 after vaccination. On days 120 and 150, visits 6 and 7 will be accomplished by telephone contact / telemedicine conference or, if necessary, in the form of an in-person visit. 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.

Conditions

• COVID-19 Prevention

Interventions

Type	Name	Description
BIOLOGICAL	Sputnik Light	solution for intramuscular injection Composition for 1 dose (0.5 ml)

Timeline

• Start date: 2021-01-15
• Primary completion: 2021-07-20
• Completion: 2021-07-31
• First posted: 2021-01-19
• Last updated: 2021-02-02

Locations

1 site across 1 country: Russia