Evidence map›Paper›PMID 32710245›Full record

ArticleInfectious diseases and therapy2020

Long-Term Persistence of Antibody Response with Two Doses of Inactivated Hepatitis A Vaccine in Children.

Ashish Agrawal, Shafi Kolhapure, Anar Andani, Martin O C Ota, Selim Badur, Naveen Karkada, Monjori Mitra

5 registry-linked trialsAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
–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.

NCT00289757 phase4completednot on this map

Double-blind, Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Three Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 6 Month Schedule in Healthy Adult Subjects

TypeinterventionalSponsorGlaxoSmithKlineRan2004 to 2013Enrolled78ConditionsHepatitis AArmsHavrix™
NCT00291876 phase4completednot on this map

Double-blind Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Two Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers

TypeinterventionalSponsorGlaxoSmithKlineRan2004 to 2013Enrolled135ConditionsHepatitis AArmsHavrix™
NCT00875485 phase4completednot on this map

An Open Multicentre, Multicountry Study to Evaluate Long-term Antibody Persistence and Immune Memory Between Years 11 and 15 After the Primary Study HAB-084 in Which Healthy Adolescents Were Vaccinated With Twinrix™ Adult Following a Two-dose Schedule or Twinrix™ Junior Following a Three-dose Schedule.

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2014Enrolled210ConditionsHepatitis B, Hepatitis AArmsBlood sampling, Additional challenge dose
NCT01000324 phase4completednot on this map

An Open Single Centre Study to Evaluate the Long-term Antibody Persistence and Immune Memory Between 16 and 20 Years After the Primary Study HAB-028 (208127/021) in Which Healthy Adults Were Vaccinated With Twinrix Adult Following a Three-dose Schedule.

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2014Enrolled44ConditionsHepatitis A, Hepatitis BArmsBlood sampling, Engerix-B, Havrix
NCT01037114 phase4completednot on this map

An Open Single Centre Study to Evaluate the Long-term Antibody Persistence and Immune Memory Between 16 and 20 Years After the Primary Study HAB-032 (208127/022) in Which Healthy Adults Were Vaccinated With Twinrix Adult Following a Three-dose Schedule.

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2014Enrolled50ConditionsHepatitis A, Hepatitis BArmsBlood sampling, Engerix-B, Havrix
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
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.

Ashish AgrawalMedical Affairs Department, GSK, Hyderabad, India. ashish.8.agrawal@gsk.com.ORCID http://orcid.org/0000-0002-6417-3184
Shafi KolhapureMedical Affairs Department, GSK, Mumbai, India.ORCID http://orcid.org/0000-0002-3183-1259
Anar AndaniGlobal Medical Affairs, GSK, Wavre, Belgium.ORCID http://orcid.org/0000-0003-0530-5340
Martin O C OtaVaccines Scientific Affairs and Public Health, GSK, Wavre, Belgium.ORCID http://orcid.org/0000-0002-1155-2842
Selim BadurVaccines Scientific Affairs and Public Health, GSK, Istanbul, Turkey.ORCID http://orcid.org/0000-0002-1316-6259
Naveen KarkadaClinical Research & Development, GSK, Wavre, Belgium.ORCID http://orcid.org/0000-0002-7543-1345
Monjori MitraMedclin Research Pvt, Kolkata, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHepatitis A virus infection is more severe in adults than children. Although vaccination can protect adults, current childhood programs cover a large population more successfully. Childhood vaccination is, therefore, a solution to protecting adults if it induces lasting immunity. Fifteen-year protection has been demonstrated in children, but longer-term data are only available for adults. We aimed to predict long term persistence of antibody in children beyond 15 years and assess if immunological mechanisms triggered by vaccination support longer-term protection.

methodsLong-term clinical studies using hepatitis A (HAV) or A/B vaccines (HAB) containing 720 or 1440 Enzyme-linked immunosorbent assay Units (EU) of hepatitis A virus antigen were identified. Duration of persistence of antibodies and possible protection was determined by descriptively comparing antibody geometric mean concentration (GMC) kinetics, as well as GMC (95% confidence interval) at 15 years post-vaccination across studies. Immunological mechanism studies describing hepatitis A vaccination were identified.

resultsOne study in children 12-15 years (2-dose HAB 720) and four in adults (2-dose HAV 1440 and 3-dose HAB 720) showed comparable GMC kinetics and per year rates of change up to 15 years. At 15 years, the GMC in children [414.7 mEU/ml (336.9; 510.5)] was in the same range as in adults [range 282.6 (217.6; 367.0) to 550.1 (416.0; 727.4)]. Based on these data, mathematical model predictions from adult studies (showing > 85% protected at 50 years) were deemed likely to also apply to children. Studies identified, both humoral and cell-mediated responses are induced following vaccination.

conclusionBased on comparable antibody data in adults and children up to 15 years, similar longer-term antibody persistence is expected in children with 2-dose inactivated hepatitis A 720 containing vaccine at least up to 50 years. Accordingly, improving routine childhood hepatitis A vaccination coverage could protect against more severe disease in adulthood. Fig. 1 Plain language summary

trial registrationClinicalTrials.gov identifiers, NCT00875485, NCT01000324, NCT01037114, NCT00289757, NCT00291876.

Indexed as

ChildrenInactivated hepatitis A vaccineLong-term persistence

Identifiers

PMID32710245
PMCPMC7680478

What OpenQuestion holds

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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.