A novel nonlive, adjuvanted herpes zoster subunit vaccine: a report on the emerging clinical data and safety profile

References

• Gershon AA, Breuer J, Cohen JI, et al. Varicella zoster virus infection. Nat Rev Dis Primers. 2015;1:15016.
   PubMed Web of Science ®Google Scholar
• Johnson RW, Wasner G, Saddier P, Baron R. Herpes zoster and postherpetic neuralgia: optimizing management in the elderly patient. Drugs Aging. 2008;25(12):991–1006.
   PubMed Web of Science ®Google Scholar
• WHO. Varicella and herpes zoster vaccines: WHO position paper, June 2014. Wkly Epidemiol Rec. 2014;89(25):265–287. English, French.
   PubMedGoogle Scholar
• Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open. 2014;4(6):e004833.
   PubMed Web of Science ®Google Scholar
• Pinchinat S, Cebrián-Cuenca AM, Bricout H, Johnson RW. Similar herpes zoster incidence across Europe: results from a systematic literature review. BMC Infect Dis. 2013;13:170.
   PubMed Web of Science ®Google Scholar
• Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014;371(16):1526–1533.
   PubMed Web of Science ®Google Scholar
• Johnson RW, Bouhassira D, Kassianos G, Leplège A, Schmader KE, Weinke T. The impact of herpes zoster and post-herpetic neuralgia on quality-of-life. BMC Med. 2010;8:37.
   PubMed Web of Science ®Google Scholar
• Lukas K, Edte A, Bertrand I. The impact of herpes zoster and post-herpetic neuralgia on quality of life: patient-reported outcomes in six European countries. Z Gesundh Wiss. 2012;20(4):441–451.
   PubMedGoogle Scholar
• Zhang Y, Luo G, Huang Y, Yu Q, Wang L, Li K. Risk of stroke/transient ischemic attack or myocardial infarction with herpes zoster: a systematic review and meta-analysis. J Stroke Cerebrovasc Dis. 2017;26(8):1807–1816.
   PubMed Web of Science ®Google Scholar
• Marra F, Ruckenstein J, Richardson K. A meta-analysis of stroke risk following herpes zoster infection. BMC Infect Dis. 2017;17(1):198.
   PubMedGoogle Scholar
• Valente N, Cocchio S, Stefanati A, et al. Temporal trends in herpes zoster-related hospitalizations in Italy, 2001-2013: differences between regions that have or have not implemented varicella vaccination. Aging Clin Exp Res. 2017;29(4):771–779.
   PubMed Web of Science ®Google Scholar
• Panatto D, Bragazzi NL, Rizzitelli E, et al. Evaluation of the economic burden of herpes zoster (HZ) infection. Hum Vaccin Immunother. 2015;11(1):245–262.
   PubMed Web of Science ®Google Scholar
• Gabutti G, Franco E, Bonanni P, et al. Reducing the burden of herpes zoster in Italy. Hum Vaccin Immunother. 2015;11(1):101–107.
   PubMed Web of Science ®Google Scholar
• Oxman MN, Levin MJ, Johnson GR, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005;352(22):2271–2284.
   PubMed Web of Science ®Google Scholar
• Tseng HF, Chi M, Smith N, Marcy SM, Sy LS, Jacobsen SJ. Herpes zoster vaccine and the incidence of recurrent herpes zoster in an immunocompetent elderly population. J Infect Dis. 2012;206(2):190–196.
   PubMed Web of Science ®Google Scholar
• Stefanati A, Valente N, Lupi S, et al. Herpes zoster vaccination in the elderly subjects: improving awareness and uptake. Patient Intell. 2015;7:5–20.
   Google Scholar
• Schmader KE, Levin MJ, Gnann JW, et al. Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years. Clin Infect Dis. 2012;54(7):922–928.
   PubMed Web of Science ®Google Scholar
• Cook SJ, Flaherty DK. Review of the persistence of herpes zoster vaccine efficacy in clinical trials. Clin Ther. 2015;37(11):2388–2397.
   PubMed Web of Science ®Google Scholar
• Schmader KE, Oxman MN, Levin MJ, et al; Shingles Prevention Study Group. Persistence of the efficacy of zoster vaccine in the shingles prevention study and the short-term persistence substudy. Clin Infect Dis. 2012;55(10):1320–1328.
   PubMed Web of Science ®Google Scholar
• Morrison VA, Johnson GR, Schmader KE, et al; Shingles Prevention Study Group. Long-term persistence of zoster vaccine efficacy. Clin Infect Dis. 2015;60(6):900–909.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency (EMA). SPC Zostavax. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000674/WC500053462.pdf. Accessed May 10, 2018.
   Google Scholar
• Levin MJ, Schmader KE, Pang L, et al. Cellular and humoral responses to a second dose of herpes zoster vaccine administered 10 years after the first dose among older adults. J Infect Dis. 2016;213(1):14–22.
   PubMed Web of Science ®Google Scholar
• Tseng HF, Smith N, Harpaz R, Bialek SR, Sy LS, Jacobsen SJ. Herpes zoster vaccine in older adults and the risk of subsequent herpes zoster disease. JAMA. 2011;305(2):160–166.
   PubMed Web of Science ®Google Scholar
• Zhang J, Delzell E, Xie F, et al. The use, safety, and effectiveness of herpes zoster vaccination in individuals with inflammatory and autoimmune diseases: a longitudinal observational study. Arthritis Res Ther. 2011;13(5):R174.
   PubMed Web of Science ®Google Scholar
• Baxter R, Bartlett DJ, Fireman B, et al. Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort Study. Am J Epidemiol. 2018;187(1):161–169.
   PubMed Web of Science ®Google Scholar
• Langan SM, Smeeth L, Margolis DJ, Thomas SL. Herpes zoster vaccine effectiveness against incident herpes zoster and post-herpetic neuralgia in an older US population: a cohort study. PLoS Med. 2013;10(4):e1001420.
   PubMed Web of Science ®Google Scholar
• Tseng HF, Tartof S, Harpaz R, et al. Vaccination against zoster remains effective in older adults who later undergo chemotherapy. Clin Infect Dis. 2014;59(7):913–919.
   PubMed Web of Science ®Google Scholar
• Tseng HF, Harpaz R, Luo Y, et al. Declining effectiveness of herpes zoster vaccine in adults aged ≥60 years. J Infect Dis. 2016;213(12):1872–1875.
   PubMed Web of Science ®Google Scholar
• Izurieta HS, Wernecke M, Kelman J, et al. Effectiveness and duration of protection provided by the live-attenuated herpes zoster vaccine in the Medicare population ages 65 years and older. Clin Infect Dis. 2017;64(6):785–793.
   PubMed Web of Science ®Google Scholar
• Marin M, Yawn BP, Hales CM, et al. Herpes zoster vaccine effectiveness and manifestations of herpes zoster and associated pain by vaccination status. Hum Vaccin Immunother. 2015;11(5):1157–1164.
   PubMed Web of Science ®Google Scholar
• Maggi S, Gabutti G, Franco E, et al. Preventing and managing herpes zoster: key actions to foster healthy aging. Aging Clin Exp Res. 2015;27(1):5–11.
   PubMed Web of Science ®Google Scholar
• Harpaz R, Ortega-Sanchez IR, Seward JF. Advisory committee on immunization practices (ACIP) centers for disease control and prevention (CDC). Prevention of herpes zoster: recommendations of the advisory committee on immunization practices (ACIP). MMWR Recomm Rep. 2008;57(RR–5):1–30.
   PubMedGoogle Scholar
• Macintyre CR, Egerton T, Mccaughey M, et al. Concomitant administration of zoster and pneumococcal vaccines in adults ≥60 years old. Hum Vaccin. 2010;6(11):894–902.
   PubMed Web of Science ®Google Scholar
• Tseng HF, Smith N, Sy LS, Jacobsen SJ. Evaluation of the incidence of herpes zoster after concomitant administration of zoster vaccine and polysaccharide pneumococcal vaccine. Vaccine. 2011;29(20):3628–3632.
   PubMed Web of Science ®Google Scholar
• Bruxvoort K, Sy LS, Luo Y, Tseng HF. Real world evidence for regulatory decisions: concomitant administration of zoster vaccine live and pneumococcal polysaccharide vaccine. Am J Epidemiol. Epub 2018 Apr 11.
   Google Scholar
• Amirthalingam G, Andrews N, Keel P, et al. Evaluation of the effect of the herpes zoster vaccination programme 3 years after its introduction in England: a population-based study. Lancet Public Health. 2018;3(2):e82–e90.
   PubMed Web of Science ®Google Scholar
• Walker JL, Andrews NJ, Amirthalingam G, Forbes H, Langan SM, Thomas SL. Effectiveness of herpes zoster vaccination in an older United Kingdom population. Vaccine. 2018;36(17):2371–2377.
   PubMed Web of Science ®Google Scholar
• Lal H, Cunningham AL, Godeaux O, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087–2096.
   PubMed Web of Science ®Google Scholar
• Cunningham AL, Heineman TC, Lal H, et al; ZOE-50/70 Study Group. Immune responses to a recombinant glycoprotein E herpes zoster vaccine in adults aged ≥50 Years. J Infect Dis. 2018;217(11):1750–1760.
   PubMed Web of Science ®Google Scholar
• Cunningham AL, Lal H, Kovac M, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019–1032.
   PubMed Web of Science ®Google Scholar
• Coccia M, Collignon C, Hervé C, et al. Cellular and molecular synergy in AS01-adjuvanted vaccines results in an early IFNγ response promoting vaccine immunogenicity. NPJ Vaccines. 2017;2:25.
   PubMed Web of Science ®Google Scholar
• Dendouga N, Fochesato M, Lockman L, Mossman S, Giannini SL. Cell-mediated immune responses to a varicella-zoster virus glycoprotein E vaccine using both a TLR agonist and QS21 in mice. Vaccine. 2012;30(20):3126–3135.
   PubMed Web of Science ®Google Scholar
• Leroux-Roels I, Leroux-Roels G, Clement F, et al. A phase 1/2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults. J Infect Dis. 2012;206(8):1280–1290.
   PubMed Web of Science ®Google Scholar
• Lal H, Zahaf T, Heineman TC. Safety and immunogenicity of an AS01-adjuvanted varicella zoster virus subunit candidate vaccine (HZ/su): a phase-I, open-label study in Japanese adults. Hum Vaccin Immunother. 2013;9(7):1425–1429.
   PubMed Web of Science ®Google Scholar
• Chlibek R, Bayas JM, Collins H, et al. Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age. J Infect Dis. 2013;208(12):1953–1961.
   PubMed Web of Science ®Google Scholar
• Chlibek R, Smetana J, Pauksens K, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014;32(15):1745–1753.
   PubMed Web of Science ®Google Scholar
• Chlibek R, Pauksens K, Rombo L, et al. Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults. Vaccine. 2016;34(6):863–868.
   PubMed Web of Science ®Google Scholar
• Schwarz TF, Volpe S, Catteau G, et al. Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults. Hum Vaccin Immunother. 2018;14(6):1370–1377.
   PubMed Web of Science ®Google Scholar
• Lal H, Poder A, Campora L, et al. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: results of a phase III, randomized, open-label, multicenter study. Vaccine. 2018;36(1):148–154.
   PubMed Web of Science ®Google Scholar
• Godeaux O, Kovac M, Shu D, et al. Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50years of age with a prior history of herpes zoster: a phase III, non-randomized, open-label clinical trial. Hum Vaccin Immunother. 2017;13(5):1051–1058.
   PubMed Web of Science ®Google Scholar
• Grupping K, Campora L, Douha M, et al. Immunogenicity and safety of the HZ/su adjuvanted herpes zoster subunit vaccine in adults previously vaccinated with a live attenuated herpes zoster vaccine. J Infect Dis. 2017;216(11):1343–1351.
   PubMed Web of Science ®Google Scholar
• Vink P, Shiramoto M, Ogawa M, et al. Safety and immunogenicity of a herpes zoster subunit vaccine in Japanese population aged ≥50years when administered subcutaneously vs. intramuscularly. Hum Vaccin Immunother. 2017;13(3):574–578.
   PubMed Web of Science ®Google Scholar
• Cunningham AL. The herpes zoster subunit vaccine. Expert Opin Biol Ther. 2016;16(2):265–271.
   PubMed Web of Science ®Google Scholar
• Berkowitz EM, Moyle G, Stellbrink HJ, et al; Zoster-015 HZ/su Study Group. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study. J Infect Dis. 2015;211(8):1279–1287.
   PubMed Web of Science ®Google Scholar
• Stadtmauer EA, Sullivan KM, Marty FM, et al. A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood. 2014;124(19):2921–2929.
   PubMed Web of Science ®Google Scholar
• [webpage on the Internet]. Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster Vaccine GSK1437173A. Available from: https://www.clinicaltrials.gov/ct2/show/results/NCT01610414?term=01610414#x0026;&rank=1bsect=X01256#all. NLM identifier: NCT01610414 Accessed July 19, 2018.
   Google Scholar
• Schwarz TF, Aggarwal N, Moeckesch B, et al. Immunogenicity and Safety of an adjuvanted herpes zoster subunit vaccine coadministered with seasonal influenza vaccine in adults aged 50 years or older. J Infect Dis. 2017;216(11):1352–1361.
   PubMed Web of Science ®Google Scholar
• Food and Drugs Administration (FDA). Shingrix Highlights of Prescribing Information. Available from: https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm581605.pdf. Accessed May 14, 2018.
   Google Scholar
• Cunningham AL, Heineman T. Vaccine profile of herpes zoster (HZ/su) subunit vaccine. Expert Rev Vaccines. 2017;16(7):661–670.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency (EMA). SPC Shingrix. Available from: http://www.ema.europa.eu/docs/it_IT/document_library/EPAR_-_Product_Information/human/004336/WC500246550.pdf. Accessed May 22, 2018.
   Google Scholar
• Kovac M, Lal H, Cunningham AL, et al; ZOE-50/70 Study Group. Complications of herpes zoster in immunocompetent older adults: incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 2018;36(12):1537–1541.
   PubMed Web of Science ®Google Scholar
• Curran D, van Oorschot D, Varghese L, et al. Assessment of the potential public health impact of herpes zoster vaccination in Germany. Hum Vaccin Immunother. 2017;13(10):2213–2221.
   PubMed Web of Science ®Google Scholar
• Watanabe D, Mizukami A, Holl K, et al. The potential public health impact of herpes zoster vaccination of people aged ≥ 50 years in Japan: results of a Markov model analysis. Dermatol Ther (Heidelb). 2018;8:269–284.
   PubMed Web of Science ®Google Scholar
• Le P, Rothberg MB. Cost-effectiveness of the adjuvanted herpes zoster subunit vaccine in older adults. JAMA Intern Med. 2018;178(2):248–258.
   PubMed Web of Science ®Google Scholar
• Dooling KL, Guo A, Patel M, et al. Recommendations of the advisory committee on immunization practices for use of herpes zoster vaccines. MMWR Morb Mortal Wkly Rep. 2018;67(3):103–108.
   PubMed Web of Science ®Google Scholar
• Maréchal C, Lal H, Poder A, et al. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine co-administered with the 23-valent pneumococcal polysaccharide vaccine in adults ≥50years of age: a randomized trial. Vaccine. 2018;36(29):4278–4286.
   PubMed Web of Science ®Google Scholar
• [webpage on the Internet]. Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant. Available from: https://clinicaltrials.gov/ct2/show/NCT02058589?term=NCT02058589&rank=1. NLM identifier: NCT02058589 Accessed May 23, 2018.
   Google Scholar
• [webpage on the Internet]. Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy. Available from: https://clinicaltrials.gov/ct2/show/NCT01798056?term=NCT01798056&rank=1. NLM identifier: NCT01798056 Accessed May 23, 2018.
   Google Scholar
• [webpage on the Internet]. Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers. Available from: https://clinicaltrials.gov/ct2/show/NCT01767467?term=NCT01767467&rank=1. NLM identifier: NCT01767467 Accessed May 23, 2018.
   Google Scholar