drugset / Trial / NCT04973449
Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The aim of the study is to assess the safety, and immunogenicity of AZD2816 for the prevention of coronavirus disease 2019 (COVID-19).
Timeline
- Start
- 2021-06-27
- Primary completion
- 2022-02-04
- Completion
- 2022-08-02
Outcome
Met primary endpoint
registry GMT ratio 1.19 (95% CI 1.08 to 1.32) NCT04973449 ↗
registry GMT ratio 1.02 (95% CI 0.90 to 1.14) NCT04973449 ↗
registry Seroresponse difference 1.68 (95% CI -3.11 to 6.49) NCT04973449 ↗
registry GMT ratio 3.47 (95% CI 3.09 to 3.89) NCT04973449 ↗
paper Co-primary immunogenicity endpoints were met: PMID 38878794 ↗
Publications
- Costa Clemens SA, Jepson B, Bhorat QE, Ahmad A, Akhund T, Aley PK, Bansal H, Bibi S, Kelly EJ, Khan M, Lambe T, Lombaard JJ, Matthews S, Pipolo Milan E, Olsson U, Ramasamy MN, Moura de Oliveira Paiva MS, Seegobin S, Shoemaker K, Szylak A, Villafana T, Pollard AJ, Green JA; AZD2816 Study Group. 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. Lancet Microbe. 2024 Aug;5(8):100863. doi: 10.1016/S2666-5247(24)00078-8. Epub 2024 Jun 12.
- Ramasamy MN, Kelly EJ, Seegobin S, Dargan PI, Payne R, Libri V, Adam M, Aley PK, Martinez-Alier N, Church A, Jepson B, Khan M, Matthews S, Townsend GT, Vekemans J, Bibi S, Swanson PA 2nd, Lambe T, Pangalos MN, Villafana T, Pollard AJ, Green JA; AZD2816 Study Group. 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. Lancet Microbe. 2023 Nov;4(11):e863-e874. doi: 10.1016/S2666-5247(23)00177-5. Epub 2023 Sep 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AZD1222 | Vaccine | 5e+10 vg | Intramuscular |
| Subject | AZD2816 | Vaccine | 5e+10 vg | — |