Immunogenicity of high-dose trivalent inactivated influenza vaccine: a systematic review and meta-analysis

References

• Disease burden of influenza [Internet]. Atlanta: US Centers for Disease Control and Prevention; 2018 [cited 2018 Jun 29]. Available from: https://www.cdc.gov/flu/about/disease/burden.htm
   Google Scholar
• Molinari NA, Ortega-Sanchez IR, Messonnier ML, et al. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007;25(27):5086–5096.
   PubMed Web of Science ®Google Scholar
• Factsheet about seasonal influenza [Internet]. European Centre for Disease Prevention and Control; 2018 [cited 2018 Jun 29]. Available from: https://ecdc.europa.eu/en/seasonal-influenza/facts/factsheet
   Google Scholar
• Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA. 2004;292(11):1333–1340.
   PubMed Web of Science ®Google Scholar
• Barker WH, Mullooly JP. Pneumonia and influenza deaths during epidemics: implications for prevention. Arch Intern Med. 1982;142(1):85–89.
   PubMed Web of Science ®Google Scholar
• Thompson MG, Shay DK, Zhou H, et al. Estimates of deaths associated with seasonal influenza — United States, 1976-2007. MMWR Morb Mortal Wkly Rep. 2010;59(33):1057–1062.
   PubMedGoogle Scholar
• Rolfes MA, Foppa IM, Garg S, et al. Annual estimates of the burden of seasonal influenza in the United States: a tool for strengthening influenza surveillance and preparedness. Influenza Other Respir Viruses. 2018;12(1):132–137.
   PubMed Web of Science ®Google Scholar
• Zheng B, Zhang Y, He H, et al. Rectification of age-associated deficiency in cytotoxic T cell response to influenza A virus by immunization with immune complexes. J Immunol. 2007;179(9):6153–6159.
   PubMed Web of Science ®Google Scholar
• Targonski PV, Jacobson RM, Poland GA. Immunosenescence: role and measurement in influenza vaccine response among the elderly. Vaccine. 2007;25(16):3066–3069.
   PubMed Web of Science ®Google Scholar
• Legrand J, Vergu E, Flahault A. Real-time monitoring of the influenza vaccine field effectiveness. Vaccine. 2006;24(44–46):6605–6611.
   PubMed Web of Science ®Google Scholar
• de Araujo AL, Silva LC, Fernandes JR, et al. Preventing or reversing immunosenescence: can exercise be an immunotherapy? Immunotherapy. 2013;5(8):879–893.
   PubMed Web of Science ®Google Scholar
• Gross PA, Weksler ME, Quinnan GV Jr., et al. Immunization of elderly people with two doses of influenza vaccine. J Clin Microbiol. 1987;25(9):1763–1765.
   PubMed Web of Science ®Google Scholar
• Robertson CA, DiazGranados CA, Decker MD, et al. Fluzone(R) high-dose influenza vaccine. Expert Rev Vaccines. 2016;15(12):1495–1505.
   PubMed Web of Science ®Google Scholar
• An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI): Canadian immunization guide chapter on influenza and interim statement on seasonal influenza vaccine for 2016-2017 [Internet]. Public Health Agency of Canada; 2016 [cited 2018 Jun 29]. Available from: http://www.phac-aspc.gc.ca/naci-ccni/assets/pdf/flu-2016-grippe-eng.pdf
   Google Scholar
• Falsey AR, Treanor JJ, Tornieporth N, et al. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009;200(2):172–180.
   PubMed Web of Science ®Google Scholar
• DiazGranados CA, Dunning AJ, Kimmel M, et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014;371(7):635–645.
   PubMed Web of Science ®Google Scholar
• Gravenstein S, Davidson HE, Taljaard M, et al. Comparative effectiveness of high-dose versus standard-dose influenza vaccination on numbers of US nursing home residents admitted to hospital: a cluster-randomised trial. Lancet Respir Med. 2017;5(9):738–746.
   PubMed Web of Science ®Google Scholar
• Gravenstein S, Davidson HE, Han LF, et al. Feasibility of a cluster-randomized influenza vaccination trial in U.S. nursing homes: lessons learned. Hum Vaccin Immunother. 2018;14(3):736–743.
   PubMed Web of Science ®Google Scholar
• Izurieta HS, Thadani N, Shay DK, et al. Comparative effectiveness of high-dose versus standard-dose influenza vaccines in US residents aged 65 years and older from 2012 to 2013 using medicare data: a retrospective cohort analysis. Lancet Infect Dis. 2015;15(3):293–300.
   PubMed Web of Science ®Google Scholar
• Shay DK, Chillarige Y, Kelman J, et al. Comparative effectiveness of high-dose versus standard-dose influenza vaccines among US medicare beneficiaries in preventing postinfluenza deaths during 2012-2013 and 2013-2014. J Infect Dis. 2017;215(4):510–517.
   PubMed Web of Science ®Google Scholar
• Young-Xu Y, Van Aalst R, Mahmud SM, et al. Relative vaccine effectiveness of high-dose versus standard-dose influenza vaccines among veterans health administration patients. J Infect Dis. 2018;217(11):1718–1727.
   PubMed Web of Science ®Google Scholar
• Lee JKH, Lam GKL, Shin T, et al. Efficacy and effectiveness of high-dose versus standard-dose influenza vaccination for older adults: a systematic review and meta-analysis. Expert Rev Vaccines. 2018;17(5):435–443.
   PubMed Web of Science ®Google Scholar
• Wilkinson K, Wei Y, Szwajcer A, et al. Efficacy and safety of high-dose influenza vaccine in elderly adults: A systematic review and meta-analysis. Vaccine. 2017;35(21):2775–2780.
   PubMed Web of Science ®Google Scholar
• Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1–12.
   PubMedGoogle Scholar
• Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21(11):1539–1558.
   PubMed Web of Science ®Google Scholar
• Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ. 2003;327(7414):557–560.
   PubMed Web of Science ®Google Scholar
• Tsang P, Gorse GJ, Strout CB, et al. Immunogenicity and safety of fluzone® intradermal and high-dose influenza vaccines in older adults ≥ 65 years of age: a randomized, controlled, phase II trial. Vaccine. 2014;32(21):2507–2517.
   PubMed Web of Science ®Google Scholar
• DiazGranados CA, Dunning AJ, Jordanov E, et al. High-dose trivalent influenza vaccine compared to standard dose vaccine in elderly adults: safety, immunogenicity and relative efficacy during the 2009-2010 season. Vaccine. 2013;31(6):861–866.
   PubMed Web of Science ®Google Scholar
• Keitel WA, Atmar RL, Cate TR, et al. Safety of high doses of influenza vaccine and effect on antibody responses in elderly persons. Arch Intern Med. 2006;166(10):1121–1127.
   PubMedGoogle Scholar
• Couch RB, Winokur P, Brady R, et al. Safety and immunogenicity of a high dosage trivalent influenza vaccine among elderly subjects. Vaccine. 2007;25(44):7656–7663.
   PubMed Web of Science ®Google Scholar
• Study of fluzone® influenza virus vaccine 2011-2012 formulation (Intramuscular Route) among adults (NCT01430819) [Internet]. Bethesda (MD): ClinicalTrials.gov; 2011 [cited 2018 Apr 10]. Available from: https://clinicaltrials.gov/ct2/show/results/NCT01430819
   Google Scholar
• Merani S, Kuchel GA, Kleppinger A, et al. Influenza vaccine-mediated protection in older adults: impact of influenza infection, cytomegalovirus serostatus and vaccine dosage. Exp Gerontol. 2018;107:116–125.
   PubMed Web of Science ®Google Scholar
• Kim JH, Talbot HK, Mishina M, et al. High-dose influenza vaccine favors acute plasmablast responses rather than long-term cellular responses. Vaccine. 2016;34(38):4594–4601.
   PubMed Web of Science ®Google Scholar
• Chen WH, Cross AS, Edelman R, et al. Antibody and Th1-type cell-mediated immune responses in elderly and young adults immunized with the standard or a high dose influenza vaccine. Vaccine. 2011;29(16):2865–2873.
   PubMed Web of Science ®Google Scholar
• DiazGranados CA, Dunning AJ, Robertson CA, et al. Effect of previous-year vaccination on the efficacy, immunogenicity, and safety of high-dose inactivated influenza vaccine in older adults. Clin Infect Dis. 2016;62(9):1092–1099.
   PubMed Web of Science ®Google Scholar
• Dunning AJ, DiazGranados CA, Voloshen T, et al. Correlates of protection against influenza in the elderly: results from an influenza vaccine efficacy trial. Clin Vaccine Immunol. 2016;23(3):228–235.
   PubMed Web of Science ®Google Scholar
• DiazGranados CA, Dunning AJ, Robertson CA, et al. Efficacy and immunogenicity of high-dose influenza vaccine in older adults by age, comorbidities, and frailty. Vaccine. 2015;33(36):4565–4571.
   PubMed Web of Science ®Google Scholar
• Nace DA, Lin CJ, Ross TM, et al. Randomized, controlled trial of high-dose influenza vaccine among frail residents of long-term care facilities. J Infect Dis. 2015;211(12):1915–1924.
   PubMed Web of Science ®Google Scholar
• Cate TR, Rayford Y, Nino D, et al. A high dosage influenza vaccine induced significantly more neuraminidase antibody than standard vaccine among elderly subjects. Vaccine. 2010;28(9):2076–2079.
   PubMed Web of Science ®Google Scholar
• La Gruta NL, Turner SJ. T cell mediated immunity to influenza: mechanisms of viral control. Trends Immunol. 2014;35(8):396–402.
   PubMed Web of Science ®Google Scholar
• McElhaney JE, Xie D, Hager WD, et al. T cell responses are better correlates of vaccine protection in the elderly. J Immunol. 2006;176(10):6333–6339.
   PubMed Web of Science ®Google Scholar
• McElhaney JE, Ewen C, Zhou X, et al. Granzyme B: correlates with protection and enhanced CTL response to influenza vaccination in older adults. Vaccine. 2009;27(18):2418–2425.
   PubMed Web of Science ®Google Scholar
• Pilkinton MA, Nicholas KJ, Warren CM, et al. Greater activation of peripheral T follicular helper cells following high dose influenza vaccine in older adults forecasts seroconversion. Vaccine. 2017;35(2):329–336.
   PubMed Web of Science ®Google Scholar
• Natori Y, Shiotsuka M, Slomovic J, et al. A double-blind, randomized trial of high-dose vs standard-dose influenza vaccine in adult solid-organ transplant recipients. Clin Infect Dis. 2018;66(11):1698–1704.
   PubMed Web of Science ®Google Scholar
• GiaQuinta S, Michaels MG, McCullers JA, et al. Randomized, double-blind comparison of standard-dose vs high-dose trivalent inactivated influenza vaccine in pediatric solid organ transplant patients. Pediatr Transplant. 2015;19(2):219–228.
   PubMed Web of Science ®Google Scholar
• Halasa NB, Savani BN, Asokan I, et al. Randomized double-blind study of the safety and immunogenicity of standard-dose trivalent inactivated influenza vaccine versus high-dose trivalent inactivated influenza vaccine in adult hematopoietic stem cell transplantation patients. Biol Blood Marrow Transplant. 2016;22(3):528–535.
   PubMed Web of Science ®Google Scholar
• Hakim H, Allison KJ, Van de Velde LA, et al. Immunogenicity and safety of high-dose trivalent inactivated influenza vaccine compared to standard-dose vaccine in children and young adults with cancer or HIV infection. Vaccine. 2016;34(27):3141–3148.
   PubMed Web of Science ®Google Scholar
• McManus M, Frangoul H, McCullers JA, et al. Safety of high dose trivalent inactivated influenza vaccine in pediatric patients with acute lymphoblastic leukemia. Pediatr Blood Cancer. 2014;61(5):815–820.
   PubMed Web of Science ®Google Scholar
• Jamshed S, Walsh EE, Dimitroff LJ, et al. Improved immunogenicity of high-dose influenza vaccine compared to standard-dose influenza vaccine in adult oncology patients younger than 65 years receiving chemotherapy: a pilot randomized clinical trial. Vaccine. 2016;34(5):630–635.
   PubMed Web of Science ®Google Scholar
• McKittrick N, Frank I, Jacobson JM, et al. Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial. Ann Intern Med. 2013;158(1):19–26.
   PubMed Web of Science ®Google Scholar
• DiazGranados CA, Saway W, Gouaux J, et al. Safety and immunogenicity of high-dose trivalent inactivated influenza vaccine in adults 50-64 years of age. Vaccine. 2015;33(51):7188–7193.
   PubMed Web of Science ®Google Scholar
• TIV and high dose TIV in subjects with rheumatoid arthritis (NCT01436370) [Internet]. Bethesda (MD): ClinicalTrials.gov; 2011 [cited 2018 Apr 10]. Available from: https://clinicaltrials.gov/ct2/show/results/NCT01436370
   Google Scholar
• Reber A, Katz J. Immunological assessment of influenza vaccines and immune correlates of protection. Expert Rev Vaccines. 2013;12(5):519–536.
   PubMed Web of Science ®Google Scholar
• McElhaney JE. Influenza vaccine responses in older adults. Ageing Res Rev. 2011;10(3):379–388.
   PubMed Web of Science ®Google Scholar
• Couch RB, Atmar RL, Franco LM, et al. Antibody correlates and predictors of immunity to naturally occurring influenza in humans and the importance of antibody to the neuraminidase. J Infect Dis. 2013;207(6):974–981.
   PubMed Web of Science ®Google Scholar
• Spellberg B, Edwards JE Jr. Type 1/Type 2 immunity in infectious diseases. Clin Infect Dis. 2001;32(1):76–102.
   PubMed Web of Science ®Google Scholar
• Sridhar S, Begom S, Bermingham A, et al. Cellular immune correlates of protection against symptomatic pandemic influenza. Nat Med. 2013;19(10):1305–1312.
   PubMed Web of Science ®Google Scholar
• Gravenstein S, Taljaard M, Gozalo P, et al. Relative effect of high-dose influenza vaccination on hospitalizations of older adults in U.S. nursing homes: results from a cluster-randomized controlled trial. Oral abstract presented at: IDWeek 2015; 2015 Oct 7–11; San Diego, CA.
   Google Scholar
• Bartoszko JJ, McNamara IF, Aras OAZ, et al. Does consecutive influenza vaccination reduce protection against influenza: a systematic review and meta-analysis. Vaccine. 2018;36(24):3434–3444.
   PubMed Web of Science ®Google Scholar
• Zbinden D, Manuel O. Influenza vaccination in immunocompromised patients: efficacy and safety. Immunotherapy. 2014;6(2):131–139.
   PubMed Web of Science ®Google Scholar
• Cao W, Kim JH, Chirkova T, et al. Improving immunogenicity and effectiveness of influenza vaccine in older adults. Expert Rev Vaccines. 2011;10(11):1529–1537.
   PubMed Web of Science ®Google Scholar
• Matias G, Taylor R, Haguinet F, et al. Estimates of mortality attributable to influenza and RSV in the United States during 1997-2009 by influenza type or subtype, age, cause of death, and risk status. Influenza Other Respir Viruses. 2014;8(5):507–515.
   PubMed Web of Science ®Google Scholar
• Quandelacy TM, Viboud C, Charu V, et al. Age- and sex-related risk factors for influenza-associated mortality in the United States between 1997-2007. Am J Epidemiol. 2014;179(2):156–167.
   PubMed Web of Science ®Google Scholar
• Olivo SA, Macedo LG, Gadotti IC, et al. Scales to assess the quality of randomized controlled trials: a systematic review. Phys Ther. 2008;88(2):156–175.
   PubMed Web of Science ®Google Scholar
• Assessing risk of bias in included studies [Internet]. Cochrane Collaboration; 2018 [cited 2018 May 24]. Available from: http://methods.cochrane.org/bias/assessing-risk-bias-included-studies
   Google Scholar
• Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315(7109):629–634.
   PubMed Web of Science ®Google Scholar
• Frey SE, Reyes MR, Reynales H, et al. Comparison of the safety and immunogenicity of an MF59(R)-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32(39):5027–5034.
   PubMed Web of Science ®Google Scholar
• Beyer WE, Nauta JJ, Palache AM, et al. Immunogenicity and safety of inactivated influenza vaccines in primed populations: a systematic literature review and meta-analysis. Vaccine. 2011;29(34):5785–5792.
   PubMed Web of Science ®Google Scholar