NCT04973449

Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults

A Phase II/III Partially Double-Blinded, Randomised, Multinational, Active-Controlled Study in Both Previously Vaccinated and Unvaccinated Adults to Determine the Safety and Immunogenicity of AZD2816, a Vaccine for the Prevention of COVID-19 Caused by Variant Strains of SARS-CoV-2

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,843 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 115 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to assess the safety, and immunogenicity of AZD2816 for the prevention of coronavirus disease 2019 (COVID-19).

Detailed description

The purpose of this study is to demonstrate the safety and characterize the immunogenicity of AZD2816; AstraZeneca's candidate chimpanzee adenovirus Ox1 (ChAdOx1) vector vaccine against severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) variant strain B.1.351.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	AZD1222	10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.
BIOLOGICAL	AZD2816	10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.

Timeline

• Start date: 2021-06-27
• Primary completion: 2022-02-04
• Completion: 2022-08-02
• First posted: 2021-07-22
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

35 sites across 4 countries: Brazil, Poland, South Africa, United Kingdom