Evidence map›Paper›PMID 31117986›Full record

Trial reportBMC infectious diseases2019

HAI and NAI titer correlates of inactivated and live attenuated influenza vaccine efficacy.

Peter B Gilbert, Youyi Fong, Michal Juraska, Lindsay N Carpp, Arnold S Monto, Emily T Martin, Joshua G Petrie

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00538512 (Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4), which is not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT00538512 phase4completednot on this map

Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

TypeinterventionalSponsorUniversity of MichiganRan2007 to 2008Enrolled1,952ConditionsInfluenzaArmsFluzone, Flumist, Physiologic saline
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. 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

7 authors at 3 institutions in 1 country.

Peter B GilbertDepartment of Biostatistics, Bioinformatics, and Epidemiology, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, 98109, USA. pgilbert@scharp.org.
Youyi FongDepartment of Biostatistics, Bioinformatics, and Epidemiology, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, 98109, USA.
Michal JuraskaDepartment of Biostatistics, Bioinformatics, and Epidemiology, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, 98109, USA.
Lindsay N CarppDepartment of Biostatistics, Bioinformatics, and Epidemiology, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, 98109, USA.
Arnold S MontoDepartment of Epidemiology, University of Michigan School of Public Health, 1415 Washington Heights, Ann Arbor, 48109, USA.
Emily T MartinDepartment of Epidemiology, University of Michigan School of Public Health, 1415 Washington Heights, Ann Arbor, 48109, USA.
Joshua G PetrieDepartment of Epidemiology, University of Michigan School of Public Health, 1415 Washington Heights, Ann Arbor, 48109, USA.
Fred Hutch Cancer Center · USUniversity of Michigan–Ann Arbor · USSeattle Pacific University · US

Funding

Statistical Methods in HIV Vaccine Efficacy TrialsR37AI054165 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert · 2010 to 2026
$6.7M
Statistical methods for HIV-1 immune correlates studiesR01AI122991 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI FONG, YOUYI · 2016 to 2020
$1.6M
FHCRC High-Performance Computing ClusterS10OD020069 · OD · FRED HUTCHINSON CANCER RESEARCH CENTER · PI KOOPERBERG, CHARLES L · 2015 to 2015
$600k
National Institute of Allergy and Infectious Diseases R01AI122991National Institute of Allergy and Infectious Diseases R37AI054165NIAID NIH HHS R01 AI122991NIAID NIH HHS R37 AI054165NIH HHS S10 OD020069
6 · The paper itself

Abstract

backgroundHigh hemagglutination inhibition (HAI) and neuraminidase inhibition (NAI) titers are generally associated with reduced influenza risk. While repeated influenza vaccination reduces seroresponse, vaccine effectiveness is not always reduced.

methodsDuring the 2007-2008 influenza season, a randomized, placebo-controlled trial (FLUVACS) evaluated the efficacies of live-attenuated (LAIV) and inactivated influenza vaccines (IIV) among healthy adults aged 18-49 in Michigan; IIV vaccine efficacy (VE) and LAIV VE against influenza disease were estimated at 68% and 36%. Using the principal stratification/VE moderation framework, we analyzed data from this trial to assess how each VE varied by HAI or NAI responses to vaccination observed for vaccinated individuals and predicted counterfactually for placebo recipients. We also assessed how each VE varied with pre-vaccination/baseline variables including HAI titer, NAI titer, and vaccination history.

resultsIIV VE appeared to increase with Day 30 post-vaccination HAI titer, albeit not significantly (p=0.20 and estimated VE 14.4%, 70.5%, and 85.5% at titer below the assay lower quantification limit, 512, and 4096 (maximum)). Moreover, IIV VE increased significantly with Day 30 post-vaccination NAI titer (p=0.040), with estimated VE zero at titer 10 and 92.2% at highest titer 640. There was no evidence that fold-change in post-vaccination HAI or NAI titer associated with IIV VE (p=0.76, 0.38). For LAIV, there was no evidence that VE associated with post-vaccination or fold-rise HAI or NAI titers (p-values >0.40). For IIV, VE increased with increasing baseline NAI titer in those previously vaccinated, but VE decreased with increasing baseline NAI titer in those previously unvaccinated. In contrast, for LAIV, VE did not depend on previous vaccination or baseline HAI or NAI titer.

conclusionsFuture efficacy trials should measure baseline and post-vaccination antibody titers in both vaccine and control/placebo recipients, enabling analyses to better elucidate correlates of vaccine- and natural-protection.

trial registrationClinicalTrials.gov NCT00538512. October 1, 2007.

Indexed as

Hemagglutination Inhibition TestsAdolescentAdultHumansImmunogenicity, VaccineImmunologic TestsInfluenza, HumanInfluenza VaccinesMiddle AgedNeuraminidasePlacebosTime FactorsVaccines, AttenuatedVaccines, InactivatedInfluenza VaccinesNeuraminidasePlacebosVaccines, AttenuatedVaccines, InactivatedFLUVACS trialHemagglutinin inhibition (HAI) titersImmune correlatesNeuraminidase inhibition (NAI) titerPrincipal stratification/vaccine efficacy moderation frameworkVaccine efficacy

Identifiers

PMID31117986
PMCPMC6530189
OpenAlexW2947890490

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.