Immunogenicity and safety of the Hz/su adjuvanted herpes zoster subunit vaccine in adults previously vaccinated with a live attenuated herpes zoster vaccine

Journal of Infectious Diseases

Volumn 216, Issue 11, 2017, Pages 1343-1351

  Grupping, Katrijn ^a   Campora, Laura ^a   Douha, Martine ^a   Heineman, Thomas C ^b   Klein, Nicola P ^c   Lal, Himal ^d   Peterson, James ^e   Vastiau, Ilse ^a   Oostvogels, Lidia ^a  

^a GSK   (Belgium)

^b Cambridge Discovery Park   (United States)

^c KAISER PERMANENTE   (United States)

^d Pfzer Specialty Care Business Unit   (United States)

^e Foothill Family Clinic   (United States)

Author keywords

Herpes zoster; Hz su adjuvanted herpes zoster subunit vaccine; Immune response; Live attenuated zoster vaccine Zostavax; Revaccination

Indexed keywords

GLYCOPROTEIN E; SUBUNIT VACCINE; VARICELLA ZOSTER VACCINE; VIRUS ANTIBODY; GLYCOPROTEIN E, VARICELLA-ZOSTER VIRUS; IMMUNOLOGICAL ADJUVANT; LIVE VACCINE; PHARMACEUTICAL VEHICLES AND ADDITIVES; VIRUS ENVELOPE PROTEIN;

ADULT; AGED; ANTIBODY TITER; ARTICLE; COHORT ANALYSIS; CONFIDENCE INTERVAL; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FEVER; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HEADACHE; HERPES ZOSTER; HUMAN; HUMAN CELL; HUMORAL IMMUNITY; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; REVACCINATION; SHIVERING; VERY ELDERLY; ADVERSE DRUG REACTION; BLOOD; CD4+ T LYMPHOCYTE; CELLULAR IMMUNITY; CLINICAL TRIAL; IMMUNOLOGY; PROCEDURES; SECONDARY IMMUNIZATION; VACCINATION; VACCINE IMMUNOGENICITY; VARICELLA ZOSTER VIRUS;

ADJUVANTS, IMMUNOLOGIC; ADJUVANTS, PHARMACEUTIC; AGED; AGED, 80 AND OVER; ANTIBODIES, VIRAL; CD4-POSITIVE T-LYMPHOCYTES; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HERPES ZOSTER; HERPES ZOSTER VACCINE; HERPESVIRUS 3, HUMAN; HUMANS; IMMUNITY, CELLULAR; IMMUNITY, HUMORAL; IMMUNIZATION, SECONDARY; IMMUNOGENICITY, VACCINE; MALE; VACCINATION; VACCINES, ATTENUATED; VACCINES, SUBUNIT; VIRAL ENVELOPE PROTEINS;

EID: 85038641428     PISSN: 00221899     EISSN: 15376613     Source Type: Journal    
DOI: 10.1093/infdis/jix482     Document Type: Article

References (32)

1. Cohen JI. Clinical practice: herpes zoster. N Engl J Med 2013; 369:255-63.
2. Cunningham AL, Dworkin RH. The management of post-herpetic neuralgia. BMJ 2000; 321:778-9.
3. Oxman MN. Herpes zoster pathogenesis and cell-mediated immunity and immunosenescence. J Am Osteopath Assoc 2009; 109:S13-7.
4. Weinberg A, Zhang JH, Oxman MN, et al; US Department of Veterans Afairs (VA) Cooperative Studies Program Shingles Prevention Study Investigators. Varicella-zoster virus-specifc immune responses to herpes zoster in elderly participants in a trial of a clinically efective zoster vaccine. J Infect Dis 2009; 200:1068-77.
5. Gershon AA, Gershon MD, Breuer J, Levin MJ, Oaklander AL, Grifths PD. Advances in the understanding of the pathogenesis and epidemiology of herpes zoster. J Clin Virol 2010; 48(Suppl 1):S2-7.
6. Ginaldi L, Loreto MF, Corsi M P, Modesti M, De Martinis M. Immunosenescence and infectious diseases. Microbes Infect 2001; 3:851-7.
7. Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open 2014; 4:e004833.
8. Johnson BH, Palmer L, Gatwood J, Lenhart G, Kawai K, Acosta CJ. Annual incidence rates of herpes zoster among an immunocompetent population in the United States. BMC Infect Dis 2015; 15:502.
9. 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; 57:1-30; quiz CE2-4.
10. Kawai K, Rampakakis E, Tsai TF, et al. Predictors of posth-erpetic neuralgia in patients with herpes zoster: a pooled analysis of prospective cohort studies from North and Latin America and Asia. Int J Infect Dis 2015; 34:126-31.
11. Yawn BP, Saddier P, Wollan PC, St Sauver JL, Kurland MJ, Sy LS. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc 2007; 82:1341-9.
12. Li Q, Chen N, Yang J, et al. Antiviral treatment for preventing postherpetic neuralgia. Cochrane Database Syst Rev 2009: CD006866. doi:10.1002/14651858.CD006866.
13. Damm O, Ultsch B, Horn J, Mikolajczyk RT, Greiner W, Wichmann O. Systematic review of models assessing the economic value of routine varicella and herpes zoster vaccination in high-income countries. BMC Public Health 2015; 15:533.
14. Schmader KE, Levin MJ, Gnann JW Jr, et al. Efcacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years. Clin Infect Dis 2012; 54:922-8.
15. Oxman MN, Levin MJ, Johnson GR, et al; Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 2005; 352:2271-84.
16. Schmader KE, Oxman MN, Levin MJ, et al; Shingles Prevention Study Group. Persistence of the efcacy of zoster vaccine in the Shingles Prevention Study and the short-term persistence substudy. Clin Infect Dis 2012; 55:1320-8.
17. Morrison VA, Johnson GR, Schmader KE, et al; Shingles Prevention Study Group. Long-term persistence of zoster vaccine efcacy. Clin Infect Dis 2015; 60:900-9.
18. Malavige GN, Jones L, Black A P, Ogg GS. Varicella zoster virus glycoprotein E-specifc CD4+ T cells show evidence of recent activation and efector diferentiation, consistent with frequent exposure to replicative cycle antigens in healthy immune donors. Clin Exp Immunol 2008; 152:522-31.
19. Vafai A. Boosting immune response with a candidate varicella-zoster virus glycoprotein subunit vaccine. Vaccine 1995; 13:1336-8.
20. Didierlaurent AM, Collignon C, Bourguignon P, et al. Enhancement of adaptive immunity by the human vaccine adjuvant AS01 depends on activated dendritic cells. J Immunol 2014; 193:1920-30.
21. Garçon N, Van Mechelen M. Recent clinical experience with vaccines using MPL-and QS-21-containing adjuvant systems. Expert Rev Vaccines 2011; 10:471-86.
22. Chlibek R, Smetana J, Pauksens K, et al. Safety and immu-nogenicity of three diferent formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine 2014; 32:1745-53.
23. Chlibek R, Bayas JM, Collins H, et al. Safety and immu-nogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age. J Infect Dis 2013; 208:1953-61.
24. Leroux-Roels I, Leroux-Roels G, Clement F, et al. A phase 1/2 clinical trial evaluating safety and immunoge-nicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults. J Infect Dis 2012; 206:1280-90.
25. Chlibek R, Pauksens K, Rombo L, et al. Long-term immu-nogenicity and safety of an investigational herpes zoster subunit vaccine in older adults. Vaccine 2016; 34:863-8.
26. Lal H, Cunningham AL, Godeaux O, et al; ZOE-50 Study Group. Efcacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med 2015; 372:2087-96.
27. Cunningham AL, Lal H, Kovac M, et al; ZOE-70 Study Group. Efcacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med 2016; 375:1019-32.
28. Tseng HF, Harpaz R, Luo Y, et al. Declining efectiveness of herpes zoster vaccine in adults aged ≥60 years. J Infect Dis 2016; 213:1872-5.
29. 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 frst dose among older adults. J Infect Dis 2016; 213:14-22.
30. 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; 211:1279-87.
31. Lal H, Zahaf T, Heineman TC. Safety and immunoge-nicity of an AS01-adjuvanted varicella zoster virus sub-unit candidate vaccine (HZ/su): a phase-I, open-label study in Japanese adults. Hum Vaccin Immunother 2013; 9:1425-9.
32. 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; 124:2921-9.