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Peer reviewedOpen accessCOVID-19SARS

Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine

npj Vaccines·

David Benkeser, Youyi Fong, Holly E. Janes, Elizabeth J. Kelly, Ian Hirsch, Stephanie Sproule, Ann Marie Stanley, Jill Maaske, Tonya Villafana, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Victor Ayala, Christos J. Petropoulos, Andrew Leith, Deanne Haugaard, Bill Webb, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Lars W. P. van der Laan, Nima S. Hejazi, Lindsay N. Carpp, April K. Randhawa, Michele P. Andrasik, James G. Kublin, Margaret Brewinski Isaacs, Mamodikoe Makhene, Tina Tong, Merlin L. Robb, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Corey Hoffman, Ann R. Falsey, Magdalena Sobieszczyk, Richard A. Koup, Ruben O. Donis, Peter B. Gilbert

DOI
10.1038/s41541-023-00630-0
PMID
36899062
PMCID
PMC10005913
OpenAlex
W4323921279
Study type
Randomised controlled trial
Publisher
Springer Science and Business Media LLC
Article type
journal-article
Integrity
current

Why this research matters now

Establishing quantitative immunological benchmarks may assist regulatory agencies in evaluating vaccine performance during approval pathways.

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Structured evidence summary

Research question

The investigation examines whether quantifiable antibody measurements can predict susceptibility to symptomatic SARS-CoV-2 infection following primary vaccination.

Study design

Researchers performed a case-cohort analysis utilizing data extracted from a multinational phase 3 randomized controlled trial.

Population and setting

The analytical cohort consisted of SARS-CoV-2 negative individuals enrolled in the trial across the United States, Chile, and Peru.

Main findings

Elevated anti-spike IgG concentrations and higher neutralizing antibody titers correlated with reduced infection risk. Estimated protection rates demonstrated substantial improvement as antibody levels surpassed low detection thresholds.

Public-health relevance

Establishing quantitative immunological benchmarks may assist regulatory agencies in evaluating vaccine performance during approval pathways.

Important limitations

The evaluation utilizes a sampled subset of trial participants rather than the complete cohort. Since explicit methodological constraints are not detailed in the provided materials, this summary relies exclusively on the supplied single-article abstract and metadata, requiring the original paper for decision-grade interpretation.

GIDS interpretation

This record supplies contextual reference material for literature tracking focused on immunological validation and vaccine policy frameworks.

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Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

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Evidence relationships

This article has 10 auditable classifier relationships to diseases, places, topics, and study design.

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