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Safety and Immunogenicity Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime Boost Regimen for the Prevention of Coronavirus Disease 2019 (COVID-19)

NCT04760730 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-10-26

No results posted yet for this study

Summary

This is a Phase I/II, parallel group, single blinded (participant blinded), randomised study assessing the immunogenicity and safety of AZD1222 and rAd26-S administered as heterologous prime-boost in alternating order in 2 study groups for the Prevention of COVID-19.

Conditions

Interventions

BIOLOGICAL

AZD1222

Active substance: ChAdOx1 nCoV-19, a replicant-deficient simian adenoviral vector in the amount of 5 х 10\^10 particles (nominal) per dose (unit dose strength \> 0.7 × 10\^11 vp/mL). Solution for intramuscular injection, supplied in vials in a carton box

BIOLOGICAL

rAd26-S

Component I (Dose 1) - (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 (unit dose strength 1 × 10\^11 vp/0.5 mL) . Solution for intramuscular injection, supplied in vials in containers

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · Chief Medical Officer, R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2022-03-29
Completion
2022-07-26

Countries

  • United Arab Emirates

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 NCT04760730 on ClinicalTrials.gov