NCT05248373

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• SARS-CoV-2 Acute Respiratory Disease

Interventions

Type	Name	Description
BIOLOGICAL	Gam-COVID-Vac	two-component combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus
OTHER	Placebo	solution with same composition as for vaccine formulation except rAds

Timeline

• Start date: 2022-03-08
• Primary completion: 2023-02-14
• Completion: 2023-12-30
• First posted: 2022-02-21
• Last updated: 2022-03-08