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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial

Authors: Barnaby Young, Sapna Sadarangani, Haur Sen Yew, Chee Fu Yung, Yee Sin Leo, Mark I-Cheng Chen, Annelies Wilder-Smith

Published in: Trials | Issue 1/2017

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Abstract

Background

The seasonal influenza vaccine is less effective in older people and a single dose is unlikely to provide the year-round protection necessary for tropical climates which have year-round influenza virus activity. This study aims to assess the effect of a trivalent inactivated influenza vaccine (IIV3) booster at 180 days on haemagglutination-inhibition (HI) antibody titres for each of the influenza strains present in the administered vaccine in older people aged 65 years or above in Singapore.

Methods/design

This is a single-centre, randomised, observer-blind, active-comparator controlled, parallel-group, phase IV trial in 200 adults aged 65 years or older. Study participants will be assigned to one of two groups in a 1:1 ratio and followed for 1 year, with five scheduled visits. The control group will receive IIV3 at day 1, and an active comparator (Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group will receive IIV3 containing the same strains at day 1 and day 180. Endpoints are immunological, and include measures of HI titres, microneutralisation titres (MN) and cell-mediated immunity from first vaccination up to day 360.

Discussion

If superiority of 6-monthly influenza vaccination is demonstrated, this study could form the basis for a larger clinical trial with influenza infection as the primary endpoint.

Trial registration

ClinicalTrials.gov, ID: NCT02655874. Registered on 12 January 2016.
Appendix
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Literature
1.
2.
Yang L, Ma S, Chen PY, He JF, Chan KP, Chow A, et al. Influenza associated mortality in the subtropics and tropics: results from three Asian cities. Vaccine. 2011;29:8909–14.CrossRefPubMed
3.
Hirve S, Newman LP, Paget J, Azziz-Baumgartner E, Fitzner J, Bhat N, et al. Influenza seasonality in the tropics and subtropics—When to vaccinate? PLoS One. 2016;11:e0153003.CrossRefPubMedPubMedCentral
4.
Saha S, Chadha M, Shu Y, Group of Asian Researchers on Influenza (GARI). Divergent seasonal patterns of influenza types A and B across latitude gradient in tropical Asia. Influenza Other Respir Viruses. 2016;10:176–84.CrossRefPubMedPubMedCentral
5.
Pebody RG, Andrews N, McMenamin J, Durnall H, Ellis J, Thompson CI, et al. Vaccine effectiveness of 2011/12 trivalent seasonal influenza vaccine in preventing laboratory-confirmed influenza in primary care in the United Kingdom: evidence of waning intra-seasonal protection. Euro Surveill Bull. Eur Sur Mal Transm. Eur Commun Dis Bull. 2013;18(5).
6.
Castilla J, Martínez-Baz I, Martínez-Artola V, Reina G, Pozo F, García Cenoz M, et al. Decline in influenza vaccine effectiveness with time after vaccination, Navarre, Spain, season 2011/12. Euro Surveill Bull. Eur Sur Mal Transm. Eur Commun Dis Bull. 2013;18(5).
7.
Sullivan SG, Komadina N, Grant K, Jelley L, Papadakis G, Kelly H. Influenza vaccine effectiveness during the 2012 influenza season in Victoria, Australia: influences of waning immunity and vaccine match. J Med Virol. 2014;86:1017–25.CrossRefPubMed
8.
Kissling E, Nunes B, Robertson C, Valenciano M, Reuss A, Larrauri A, et al. I-MOVE multicentre case-control study 2010/11 to 2014/15: is there within-season waning of influenza type/subtype vaccine effectiveness with increasing time since vaccination? Euro Surveill Bull. Eur Sur Mal Transm. Eur Commun Dis Bull. 2016;21(16).
9.
Coudeville L, Bailleux F, Riche B, Megas F, Andre P, Ecochard R. Relationship between haemagglutination-inhibiting antibody titres and clinical protection against influenza: development and application of a Bayesian random-effects model. BMC Med Res Methodol. 2010;10:18.CrossRefPubMedPubMedCentral
10.
Young B, Zhao X, Cook AR, Parry CM, Wilder-Smith A, I-Cheng MC. Do antibody responses to the influenza vaccine persist year-round in the elderly? A systematic review and meta-analysis. Vaccine. 2017;35:212–21.CrossRefPubMed
11.
Song JY, Cheong HJ, Hwang IS, Choi WS, Jo YM, Park DW, et al. Long-term immunogenicity of influenza vaccine among the elderly: risk factors for poor immune response and persistence. Vaccine. 2010;28:3929–35.CrossRefPubMed
12.
Seo YB, Baek JH, Lee J, Song JY, Lee JS, Cheong HJ, et al. Long-term immunogenicity and safety of a conventional influenza vaccine in patients with type 2 diabetes. Clin Vaccine Immunol. 2015;22:1160–5.CrossRefPubMedPubMedCentral
13.
14.
United Nations, Department of Economic and Social Affairs, Population Division. World Population Prospects: the 2015 revision, custom data acquired via website. 2015. www.​un.​org/​esa/​population. Accessed 3 Feb 2017.
15.
16.
Ohmit SE, Gross J, Victor JC, Monto AS. Reduced reaction frequencies with repeated inactivated or live-attenuated influenza vaccination. Vaccine. 2009;27:1050–4.CrossRefPubMed
17.
Darvishian M, Bijlsma MJ, Hak E, van den Heuvel ER. Effectiveness of seasonal influenza vaccine in community-dwelling elderly people: a meta-analysis of test-negative design case-control studies. Lancet Infect Dis. 2014;14:1228–39.CrossRefPubMed
18.
Seo YB, Choi WS, Lee J, Song JY, Cheong HJ, Kim WJ. Comparison of the immunogenicity and safety of the conventional subunit, MF59-adjuvanted, and intradermal influenza vaccines in the elderly. Clin Vaccine Immunol. 2014;21:989–96.CrossRefPubMedPubMedCentral
19.
Song JY, Cheong HJ, Noh JY, Seo YB, Choi WS, Cho GJ, et al. Long-term and cross-reactive immunogenicity of inactivated trivalent influenza vaccine in the elderly: MF59-adjuvanted vaccine versus unadjuvanted vaccine. J Med Virol. 2013;85:1591–7.CrossRefPubMed
20.
DiazGranados CA, Dunning AJ, Robertson CA, Talbot HK, Landolfi V, Greenberg DP. Efficacy and immunogenicity of high-dose influenza vaccine in older adults by age, comorbidities, and frailty. Vaccine. 2015;33:4565–71.CrossRefPubMed
21.
McElhaney JE, Beran J, Devaster J-M, Esen M, Launay O, Leroux-Roels G, et al. AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial. Lancet Infect Dis. 2013;13:485–96.CrossRefPubMed
22.
Frey SE, Reyes MRA-DL, Reynales H, Bermal NN, Nicolay U, Narasimhan V, et al. Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32:5027–34.CrossRefPubMed
Metadata
Title
The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial
Authors
Barnaby Young
Sapna Sadarangani
Haur Sen Yew
Chee Fu Yung
Yee Sin Leo
Mark I-Cheng Chen
Annelies Wilder-Smith
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1808-8

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