Evidence map›Paper›PMID 23555741›Full record

Trial reportPloS one2013

Evaluation of in vitro cross-reactivity to avian H5N1 and pandemic H1N1 2009 influenza following prime boost regimens of seasonal influenza vaccination in healthy human subjects: a randomised trial.

Delia Bethell, David Saunders, Anan Jongkaewwattana, Jarin Kramyu, Arunee Thitithayanont, Suwimon Wiboon-ut, Kosol Yongvanitchit, Amporn Limsalakpetch, Utaiwan Kum-Arb, Nichapat Uthaimongkol and 13 more

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

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01044095 (Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
1.4field-weighted citation impact, top 18% 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.

NCT01044095 nacompletednot on this map

Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine

TypeinterventionalSponsorArmed Forces Research Institute of Medical Sciences, ThailandRan2009 to 2012Enrolled26ConditionsInfluenzaArmsFluMist® live, attenuated, intranasal seasonal influenza vaccine, Fluzone® inactivated influenza virus vaccine
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Immunity to Influenza Infection in Humans.Cold Spring Harbor perspectives in medicine · 2021
    Review
  9. Review
  10. 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

23 authors at 4 institutions in 2 countries.

Delia BethellDepartment of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand. delia.bethell@afrims.org
David Saunders
Anan Jongkaewwattana
Jarin Kramyu
Arunee Thitithayanont
Suwimon Wiboon-ut
Kosol Yongvanitchit
Amporn Limsalakpetch
Utaiwan Kum-Arb
Nichapat Uthaimongkol
Jean Michel Garcia
Ans E Timmermans
Malik Peiris
Stephen Thomas
Anneke Engering
Richard G Jarman
Duangrat Mongkolsirichaikul
Carl Mason
Nuanpan Khemnu
Stuart D Tyner
Mark M Fukuda
Douglas S Walsh
Sathit Pichyangkul
Armed Forces Research Institute of Medical Science · THHKU-Pasteur Research Pole · HKMahidol University · THNational Center for Genetic Engineering and Biotechnology · TH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRecent studies have demonstrated that inactivated seasonal influenza vaccines (IIV) may elicit production of heterosubtypic antibodies, which can neutralize avian H5N1 virus in a small proportion of subjects. We hypothesized that prime boost regimens of live and inactivated trivalent seasonal influenza vaccines (LAIV and IIV) would enhance production of heterosubtypic immunity and provide evidence of cross-protection against other influenza viruses.

methodsIn an open-label study, 26 adult volunteers were randomized to receive one of four vaccine regimens containing two doses of 2009-10 seasonal influenza vaccines administered 8 (±1) weeks apart: 2 doses of LAIV; 2 doses of IIV; LAIV then IIV; IIV then LAIV. Humoral immunity assays for avian H5N1, 2009 pandemic H1N1 (pH1N1), and seasonal vaccine strains were performed on blood collected pre-vaccine and 2 and 4 weeks later. The percentage of cytokine-producing T-cells was compared with baseline 14 days after each dose.

resultsSubjects receiving IIV had prompt serological responses to vaccine strains. Two subjects receiving heterologous prime boost regimens had enhanced haemagglutination inhibition (HI) and neutralization (NT) titres against pH1N1, and one subject against avian H5N1; all three had pre-existing cross-reactive antibodies detected at baseline. Significantly elevated titres to H5N1 and pH1N1 by neuraminidase inhibition (NI) assay were observed following LAIV-IIV administration. Both vaccines elicited cross-reactive CD4+ T-cell responses to nucleoprotein of avian H5N1 and pH1N1. All regimens were safe and well tolerated.

conclusionNeither homologous nor heterologous prime boost immunization enhanced serum HI and NT titres to 2009 pH1N1 or avian H5N1 compared to single dose vaccine. However heterologous prime-boost vaccination did lead to in vitro evidence of cross-reactivity by NI; the significance of this finding is unclear. These data support the strategy of administering single dose trivalent seasonal influenza vaccine at the outset of an influenza pandemic while a specific vaccine is being developed.

trial registrationClinicalTrials.gov NCT01044095.

Indexed as

Cross ReactionsAdolescentAdultAnimalsAntibodies, ViralBirdsFeasibility StudiesFemaleHealthHumansImmunization, SecondaryInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H5N1 SubtypeInfluenza, HumanInfluenza in BirdsMaleAntibodies, ViralViral Vaccines

Identifiers

PMID23555741
PMCPMC3608534
OpenAlexW2063896974

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.