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Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of COVID-19

NCT04684446 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-06-03

No results posted yet for this study

Summary

The objective is to evaluate the safety and immunogenicity of AZD1222 given in combination with (either before or after) rAd26-S, for the prevention of COVID 19 in adults ≥ 18 years of age.

Conditions

Interventions

BIOLOGICAL

AZD1222

Participants will receive 1 intramuscular (IM) injection of 5 ×1010 viral particles (vp) (nominal) of AZD1222 on Day 1 followed by rAd26-S 1×1011 viral particles (vp) (nominal) on Day 29 of the study

BIOLOGICAL

rAd26-S

Participants will receive 1 IM injection of rAd26-S on Day 1 followed by AZD1222 on Day 29

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 · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2021-11-26
Completion
2022-03-29

Countries

  • Russia

Study Locations

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Diseases
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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 NCT04684446 on ClinicalTrials.gov