Trial intelligence / Profile preview

Safety and Immunogenicity of Gam-COVID-Vac (Sputnik V) in Volunteers Over 60

NCT04587219Phase 2

Key facts

Status
Unknown
Start
Oct 2020
Primary completion
Mar 2021
Countries
1
Modality
Viral Vector Vaccines
Conditions
coronavirus disease 2019 (COVID-19)
01

Overview

Phase 2, open-label, single-arm trial of Gam-COVID-Vac in coronavirus disease 2019 (COVID-19). Primary endpoints: Changing of antibody levels against the SARS-CoV-2 glycoprotein S at 42 days and Number of Participants With Adverse Events at 180 days. Status: unknown.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Gam COVID Vac Vaccine

    Prime-boost immunization with Gam-COVID-Vac

03

Who it enrols

Volunteers over 60 years old without history of COVID-19, severe allergies, or recent vaccinations.

04

Endpoints

Primary

  • Changing of antibody levels against the SARS-CoV-2 glycoprotein S

  • Number of Participants With Adverse Events

Secondary

  • Changing of virus neutralizing antibody titer

  • Changing of antigen-specific cellular immunity level

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