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Open-label, Non-randomized, Non-comparative, Phase II Study of Safety and Immunogenicity of Combination of AZD1222 and rAd26-S for COVID-19 Prevention

NCT04686773 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-06-03

No results posted yet for this study

Summary

The purpose of the study is to assess safety and immunogenicity of heterologous booster vaccine containing combination of AZD1222 and rAd26-S (one of components of Gam-COVID-Vac vaccine) in adult subjects aged ≥ 18 years old to prevent COVID-19 spread.

Conditions

Interventions

BIOLOGICAL

AZD1222

AZD1222 (0.5 ml per dose) contains: Active substance: ChAdOx1 nCoV-19, a replicant-deficient simian adenoviral vector in the amount of 5 х 10\^10 particles per dose. Solution for intramuscular injection, supplied in vials (5 mL, up to 10 doses per vial) in a carton box.

BIOLOGICAL

rAd26-S

Component I (0.5 ml per dose) contains: Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 10\^11 particles per dose. Solution for intramuscular injection, supplied in vials (3 mL, 5 doses per vial) in a carton box

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Russian Direct Investment Fund

    collaborator INDUSTRY

  • The Gamaleya National Center of Epidemiology & Microbiology

    collaborator UNKNOWN

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · Chief Medical Officer, R-Pharm

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2021-10-30
Completion
2022-03-18

Countries

  • Azerbaijan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04686773 on ClinicalTrials.gov