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Safety, Tolerability and Immunogenicity of Gam-COVID-Vac Vaccine in a Nasal Spray — SPRAY  

COVID-19 Clinical Trial

Official title:
A Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Safety, Tolerability and Immunogenicity of a Vaccine "Gam-COVID-Vac, a Combined Vector Vaccine for the Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Virus" in a Nasal Spray Dosage Form With the Participation of Adult Volunteers

Clinical Trial Summary

Randomized, double-blind, placebo-controlled trial to evaluate safety and immunogenicity of intranasal "Gam-COVID-Vak" combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus. The duration of participation in the study for one subject will be 180±14 days after the first dose of vaccine, during which each subject will undergo a screening visit (within a week) and face-to-face visits according to the study plan. Intranasal vaccine administration will be done at day 1 vaccination visits and day 21±2 days on an outpatient basis. During the follow-up visits key vital signs will be assessed, and will collect data on changes in the state and well-being subjects from a previous visit. Subject data will be collected using electronic forms of individual registration cards, as well as with using questionnaires (diaries) filled by the subjects of the study. Immunogenicity will be assessed on day 1, 10, 28, 42 and 90 days. Humoral and cellular immune response will be evaluated.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05248373
Study type Interventional
Source Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Contact Nadezhda L Lubenec
Phone 8 (499) 193-30-01
Email info@gamaleya.org
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date March 8, 2022
Completion date December 30, 2023
View Details
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