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Association Between Hemagglutination Inhibition Antibody Titers and Protection Against Reverse-Transcription Polymerase Chain Reaction–Confirmed Influenza Illness in Children 6–35 Months of Age: Statistical Evaluation of a Correlate of Protection

Association Between Hemagglutination Inhibition Antibody Titers and Protection Against... BackgroundData from a randomized controlled efficacy trial of an inactivated quadrivalent influenza vaccine in children 6–35 months of age were used to determine whether hemagglutination inhibition (HI) antibody titer against A/H1N1 and A/H3N2 is a statistical correlate of protection (CoP) for the risk of reverse-transcription polymerase chain reaction (RT-PCR)–confirmed influenza associated with the corresponding strain.MethodsThe Prentice criteria were used to statistically validate strain-specific HI antibody titer as a CoP. The probability of protection was identified using the Dunning model corresponding to a prespecified probability of protection at an individual level. The group-level protective threshold was identified using the Siber approach, leading to unbiased predicted vaccine efficacy (VE). A case-cohort subsample was used for this exploratory analysis.ResultsPrentice criteria confirmed that HI titer is a statistical CoP for RT-PCR–confirmed influenza. The Dunning model predicted a probability of protection of 49.7% against A/H1N1 influenza and 54.7% against A/H3N2 influenza at an HI antibody titer of 1:40 for the corresponding strain. Higher titers of 1:320 were associated with >80% probability of protection. The Siber method predicted VE of 61.0% at a threshold of 1:80 for A/H1N1 and 46.6% at 1:113 for A/H3N2.ConclusionsThe study validated HI antibody titer as a statistical CoP, by demonstrating that HI titer is correlated with clinical protection against RT-PCR–confirmed influenza associated with the corresponding influenza strain and is predictive of VE in children 6–35 months of age.Clinical Trials RegistrationNCT01439360. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Open Forum Infectious Diseases Oxford University Press

Association Between Hemagglutination Inhibition Antibody Titers and Protection Against Reverse-Transcription Polymerase Chain Reaction–Confirmed Influenza Illness in Children 6–35 Months of Age: Statistical Evaluation of a Correlate of Protection

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References (47)

Publisher
Oxford University Press
Copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
eISSN
2328-8957
DOI
10.1093/ofid/ofab477
Publisher site
See Article on Publisher Site

Abstract

BackgroundData from a randomized controlled efficacy trial of an inactivated quadrivalent influenza vaccine in children 6–35 months of age were used to determine whether hemagglutination inhibition (HI) antibody titer against A/H1N1 and A/H3N2 is a statistical correlate of protection (CoP) for the risk of reverse-transcription polymerase chain reaction (RT-PCR)–confirmed influenza associated with the corresponding strain.MethodsThe Prentice criteria were used to statistically validate strain-specific HI antibody titer as a CoP. The probability of protection was identified using the Dunning model corresponding to a prespecified probability of protection at an individual level. The group-level protective threshold was identified using the Siber approach, leading to unbiased predicted vaccine efficacy (VE). A case-cohort subsample was used for this exploratory analysis.ResultsPrentice criteria confirmed that HI titer is a statistical CoP for RT-PCR–confirmed influenza. The Dunning model predicted a probability of protection of 49.7% against A/H1N1 influenza and 54.7% against A/H3N2 influenza at an HI antibody titer of 1:40 for the corresponding strain. Higher titers of 1:320 were associated with >80% probability of protection. The Siber method predicted VE of 61.0% at a threshold of 1:80 for A/H1N1 and 46.6% at 1:113 for A/H3N2.ConclusionsThe study validated HI antibody titer as a statistical CoP, by demonstrating that HI titer is correlated with clinical protection against RT-PCR–confirmed influenza associated with the corresponding influenza strain and is predictive of VE in children 6–35 months of age.Clinical Trials RegistrationNCT01439360.

Journal

Open Forum Infectious DiseasesOxford University Press

Published: Sep 25, 2021

Keywords: HI antibodies; correlate of protection; influenza; children

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