AZD2816 / AstraZeneca, University of Oxford - LARVOL DELTA

Immunogenicity and safety of beta variant COVID-19 vaccine AZD2816 and AZD1222 (ChAdOx1 nCoV-19) as primary-series vaccination for previously unvaccinated adults in Brazil, South Africa, Poland, and the UK: a randomised, partly double-blinded, phase 2/3 non-inferiority immunobridging study. (PubMed, Lancet Microbe) - P2/3 | "Primary series of AZD1222 and AZD2816 were well tolerated, with no emergent safety concerns. Both vaccines elicited robust immunogenicity against beta and ancestral SARS-CoV-2 with greater responses demonstrated when testing against SARS-CoV-2 strains that matched those targeted by the respective vaccine. These findings demonstrate the continued importance of ancestral COVID-19 vaccines in protecting against severe COVID-19 and highlight the feasibility of using the ChAdOx1 platform to develop COVID-19 vaccines against future SARS-CoV-2 variants."

Head-to-Head • Journal • P2/3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of AZD2816, a beta (B.1.351) variant COVID-19 vaccine, and AZD1222 (ChAdOx1 nCoV-19) as third-dose boosters for previously vaccinated adults: a multicentre, randomised, partly double-blinded, phase 2/3 non-inferiority immunobridging study in the UK and Poland. (PubMed, Lancet Microbe) - P2/3 | "Both boosters were well tolerated, with immunogenicity against ancestral SARS-CoV-2 similar to AZD1222 primary-series vaccination. AZD2816 gave greater immune responses against beta versus AZD1222."

Head-to-Head • Journal • P2/3 data • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Persistently high immunogenicity and between-country differences driven by hybrid immunity from primary-series AZD2816 or AZD1222 (ChAdOx1 nCoV-19) and Omicron infections (ECCMID 2023) - No abstract available

Late-breaking abstract • Infectious Disease

Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults (clinicaltrials.gov) - P2/3 | N=2848 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ChAdOx1 nCoV-19 (AZD1222) or nCoV-19-Beta (AZD2816) protect Syrian hamsters against Beta Delta and Omicron variants. (PubMed, Nat Commun) - "In Omicron-challenged hamsters, a single dose of AZD2816 or AZD1222 reduced virus shedding. Thus, these vaccination regimens are protective against the Beta, Delta, and Omicron VoCs in the hamster model."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) and AZD2816 as third-dose boosters in adults previously vaccinated with AZD1222 or an mRNA vaccine (ECCMID 2022) - No abstract available

Clinical • Late-breaking abstract

The ChAdOx1 vectored vaccine, AZD2816, induces strong immunogenicity against SARS-CoV-2 beta (B.1.351) and other variants of concern in preclinical studies. (PubMed, EBioMedicine) - "Real world data is demonstrating that one or more doses of licensed SARS-CoV-2 vaccines confer reduced protection against hospitalisation and deaths caused by divergent VoC, including Omicron. Our data support the ongoing clinical development and testing of booster vaccines to increase immunity against highly mutated VoC."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults (clinicaltrials.gov) - P2/3; N=2849; Active, not recruiting; Sponsor: AstraZeneca; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults (clinicaltrials.gov) - P2/3; N=2849; Recruiting; Sponsor: AstraZeneca; Trial primary completion date: Oct 2021 ➔ Jan 2022

Clinical • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"$AZN AZD2816 new variant Coivid-19 vaccine ph2/3 trial reading out H2 2021" (@JacobPlieth)

Clinical

Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults (clinicaltrials.gov) - P2/3; N=2475; Recruiting; Sponsor: AstraZeneca

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases