Evidence map›Paper›PMID 35083365›Full record

ArticleOpen forum infectious diseases2022

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.

Jasur Danier, Andrea Callegaro, Jyoti Soni, Alfoso Carmona, Pope Kosalaraska, Luis Rivera, Damien Friel, Wenji Pu, Valerie Vantomme, Ghassan Dbaibo and 4 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01439360 (An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 28% of its field
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.

NCT01439360 phase3completednot on this map

An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children

TypeinterventionalSponsorGlaxoSmithKlineRan2011 to 2014Enrolled12,046ConditionsInfluenzaArmsQuadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A, Havrix Junior, Prevenar 13, Varivax/ProVarivax, Varilrix
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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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

14 authors at 8 institutions in 8 countries.

Jasur DanierGSK, Rockville, Maryland, USA.ORCID https://orcid.org/0000-0002-5032-8333
Andrea CallegaroGSK, Rixensart, Belgium.
Jyoti SoniGSK, Bangalore, India.
Alfoso CarmonaInstituto Hispalense de Pediatría, Sevilla, Spain.
Pope KosalaraskaKhon Kaen University, Khon Kaen, Thailand.
Luis RiveraNational Autonomous University of Santo Domingo, Santo Domingo, Dominican Republic.
Damien FrielGSK, Wavre, Belgium.
Wenji PuGSK, Rockville, Maryland, USA.
Valerie VantommeGSK, Rixensart, Belgium.
Ghassan DbaiboAmerican University of Beirut, Beirut, Lebanon.
Bruce L InnisGSK, King of Prussia, Pennsylvania, USA.
Anne SchuindGSK, Rockville, Maryland, USA.
Khalequ Zamanicddr,b, Dhaka, Bangladesh.
Jerome WilsonGSK, Rockville, Maryland, USA.
GlaxoSmithKline (United States) · USGlaxoSmithKline (Belgium) · BEAmerican University of Beirut · LBGlaxoSmithKline (India) · INInstituto Hispalense de Pediatria · ESInternational Centre for Diarrhoeal Disease Research · BDKhon Kaen University · THUniversidad Autónoma de Santo Domingo · DO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 REGISTRATION: NCT01439360.

Indexed as

childrencorrelate of protectionHI antibodiesinfluenza

Identifiers

PMID35083365
PMCPMC8786493
OpenAlexW3204369900

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.