Evidence map›Paper›PMID 39204009›Full record

ArticleVaccines2024

Long-Term Safety and Immunogenicity of AZD1222 (ChAdOx1 nCoV-19): 2-Year Follow-Up from a Phase 3 Study.

Kathryn Shoemaker, Karina Soboleva, Angela Branche, Shivanjali Shankaran, Deborah A Theodore, Muhammad Bari, Victor Ezeh, Justin Green, Elizabeth Kelly, Dongmei Lan and 7 more

Registry-linked trialAbstract read
In one paragraph

Article in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04516746 (A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04516746 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

TypeinterventionalSponsorAstraZenecaRan2020 to 2023Enrolled32,450ConditionsCOVID-19, SARS-CoV-2ArmsAZD1222, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Molecular mechanisms of SARS-CoV-2 entry: implications for biomedical strategies.Microbiology and molecular biology reviews : MMBR · 2025
    Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Kathryn ShoemakerBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.
Karina SobolevaClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.
Angela BrancheDivision of Infectious Diseases, Department of Medicine, University of Rochester, Rochester, NY 14627, USA.
Shivanjali ShankaranDivision of Infectious Diseases, Rush University Medical Center, Chicago, IL 60612, USA.
Deborah A TheodoreDivision of Infectious Diseases, Department of Medicine, Vagelos College of Physicians and Surgeons, New York-Presbyterian/Columbia University Irving Medical Center, New York, NY 10032, USA.
Muhammad BariFormerly Patient Safety, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge CB2 0AA, UK.
Victor EzehClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.
Justin GreenClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge CB2 0AA, UK.
Elizabeth KellyFormerly Translational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.ORCID 0000-0002-6988-8576
Dongmei LanBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.
Urban OlssonClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, 431 83 Gothenburg, Sweden.
Senthilkumar SaminathanPatient Safety, Chief Medical Office, R&D, AstraZeneca, Bangalore 560045, India.
Nirmal Kumar ShankarPatient Safety, Chief Medical Office, R&D, AstraZeneca, Bangalore 560045, India.
Berta VillegasClinical Operations, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Mississauga, ON L4Y 1M4, Canada.
Tonya VillafanaClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.
Ann R FalseyDepartment of Medicine, Infectious Diseases, University of Rochester School of Medicine and Dentistry, Rochester, New York, NY 14642, USA.
Magdalena E SobieszczykDivision of Infectious Diseases, Department of Medicine, Vagelos College of Physicians and Surgeons, New York-Presbyterian/Columbia University Irving Medical Center, New York, NY 10032, USA.

Funding

Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG) - Momi-Vax DMID #21-0004 {Supplement #6}UM1AI148684 · NIAID · EMORY UNIVERSITY · PI DAVID S STEPHENS · 2020 to 2026
$77.2M
Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials UnitUM1AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MAGDALENA ELZBIETA SOBIESZCZYK · 2012 to 2026
$44.8M
Establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU) - DMID 21-0012UM1AI148574 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Angelica Cifuentes Kottkamp, Anoma Nellore · 2020 to 2026
$23.9M
University of Rochester Vaccine and Treatment Evaluation Unit (VTEU)-mRNA-1273-P204 Moderna Pediatric StudyUM1AI148450 · NIAID · UNIVERSITY OF ROCHESTER · PI Angela Ramona Branche, Ann R Falsey · 2020 to 2026
$20.6M
Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required) - Moderna Pediatric StudyUM1AI148372 · NIAID · CINCINNATI CHILDRENS HOSP MED CTR · PI Robert Wilson Frenck · 2020 to 2026
$20.5M
Columbia Collaborative HIV/AIDS Clinical Trials UnitU01AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HAMMER, SCOTT M · 2007 to 2011
$15.4M
AstraZeneca N/ANIAID NIH HHS U01 AI069470NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI148372NIAID NIH HHS UM1 AI148450NIAID NIH HHS UM1 AI148574NIAID NIH HHS UM1 AI148684
6 · The paper itself

Abstract

A better understanding of the long-term safety, efficacy, and immunogenicity of COVID-19 vaccines is needed. This phase 3, randomized, placebo-controlled study for AZD1222 (ChAdOx1 nCoV-19) primary-series vaccination enrolled 32,450 participants in the USA, Chile, and Peru between August 2020 and January 2021 (NCT04516746). Endpoints included the 2-year follow-up assessment of safety, efficacy, and immunogenicity. After 2 years, no emergent safety signals were observed for AZD1222, and no cases of thrombotic thrombocytopenia syndrome were reported. The assessment of anti-SARS-CoV-2 nucleocapsid antibody titers confirmed the durability of AZD1222 efficacy for up to 6 months, after which infection rates in the AZD1222 group increased over time. Despite this, all-cause and COVID-19-related mortality remained low through the study end, potentially reflecting the post-Omicron decoupling of SARS-CoV-2 infection rates and severe COVID-19 outcomes. Geometric mean titers were elevated for anti-SARS-CoV-2 neutralizing antibodies at the 1-year study visit and the anti-spike antibodies were elevated at year 2, providing further evidence of increasing SARS-CoV-2 infections over long-term follow-up. Overall, this 2-year follow-up of the AZD1222 phase 3 study confirms that the long-term safety profile remains consistent with previous findings and supports the continued need for COVID-19 booster vaccinations due to waning efficacy and humoral immunity.

Indexed as

AZD1222 (ChAdOx1 nCoV-19)COVID-19COVID-19 vaccinehumoral immunogenicitylong-term safetyOmicron variantSARS-CoV-2

Identifiers

PMID39204009
PMCPMC11359581

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.