Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults

New England Journal of Medicine

Volumn 372, Issue 22, 2015, Pages 2087-2096

  Lal, Himal ^a   Cunningham, Anthony L ^b,c   Godeaux, Olivier ^d   Chlibek, Roman ^e   Diez Domingo, Javier ^f   Hwang, Shinn Jang ^g   Levin, Myron J ^h   McElhaney, Janet E ⁱ   Poder, Airi ^j   Puig Barberà, Joan ^f   Vesikari, Timo ^k   Watanabe, Daisuke ^l   Weckx, Lily ^m   Zahaf, Toufik ^d   Heineman, Thomas C ^a  

^a GLAXOSMITHKLINE   (United States)

^b WESTMEAD HOSPITAL   (Australia)

^c UNIVERSITY OF SYDNEY   (Australia)

^d GSK   (Belgium)

^e UNIVERSITY OF DEFENCE   (Czech Republic)

^f Vaccine Research   (Spain)

^g TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

^h UNIVERSITY OF COLORADO   (United States)

ⁱ Advanced Medical Research Institute of Canada   (Canada)

^j TARTU UNIVERSITY HOSPITAL   (Estonia)

^k TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^l AICHI MEDICAL UNIVERSITY   (Japan)

^m FEDERAL UNIVERSITY OF SÃO PAULO   (Brazil)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BETA ACTIN; GLYCOPROTEIN E; IMMUNOLOGICAL ADJUVANT; PLACEBO; VARICELLA ZOSTER VACCINE; VIRUS DNA; SUBUNIT VACCINE;

ADULT; AGE DISTRIBUTION; AGED; ARTICLE; ASIA; AUSTRALIA; COHORT ANALYSIS; CONTROLLED STUDY; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; EUROPE; FAINTNESS; FATIGUE; FEMALE; FEVER; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HEADACHE; HEART FAILURE; HEART INFARCTION; HERPES ZOSTER; HUMAN; HYPOTENSION; IMMUNOPATHOLOGY; INCIDENCE; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE REDNESS; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALE; MONONEUROPATHY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL CHEST PAIN; MYALGIA; NORTH AMERICA; ONSET AGE; PERCEPTION DEAFNESS; PHASE 3 CLINICAL TRIAL; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SHIVERING; SOUTH AND CENTRAL AMERICA; SYMPTOMATOLOGY; VACCINATION; ADVERSE EFFECTS; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; IMMUNOLOGY; INTRAMUSCULAR DRUG ADMINISTRATION; MIDDLE AGED; MULTICENTER STUDY; TREATMENT OUTCOME;

ADJUVANTS, IMMUNOLOGIC; AGED; DOUBLE-BLIND METHOD; FEMALE; HERPES ZOSTER; HERPES ZOSTER VACCINE; HUMANS; INJECTIONS, INTRAMUSCULAR; MALE; MIDDLE AGED; TREATMENT OUTCOME; VACCINES, SUBUNIT;

EID: 84929850029     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1501184     Document Type: Article

References (35)

1. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008;57(RR-5):1-30.
2. Cohen JI. Herpes zoster. N Engl J Med 2013;369:255-63.
3. Bonanni P, Breuer J, Gershon A, et al. Varicella vaccination in Europe - taking the practical approach. BMC Med 2009;7:26.
4. Johnson RW. Herpes zoster and postherpetic neuralgia. Expert Rev Vaccines 2010;9:Suppl:21-6.
5. Gershon AA, Gershon MD, Breuer J, Levin MJ, Oaklander AL, Griffiths PD. Advances in the understanding of the pathogenesis and epidemiology of herpes zoster. J Clin Virol 2010;48:Suppl 1:S2-S7.
6. Update on recommendations for use of herpes zoster vaccine. MMWR Morb Mortal Wkly Rep 2014;63:729-31.
7. 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;352:2271-84.
8. Schmader KE, Levin MJ, Gnann JW Jr, et al. Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years. Clin Infect Dis 2012;54:922-8.
9. Clark TG, Cassidy-Hanley D. Recombinant subunit vaccines: potentials and constraints. Dev Biol (Basel) 2005;121:153-63.
10. Plotkin SA. Vaccines: past, present and future. Nat Med 2005;11:Suppl:S5-S11.
11. Malavige GN, Jones L, Black AP, Ogg GS. Varicella zoster virus glycoprotein E-specific CD4+ T cells show evidence of recent activation and effector differentiation, consistent with frequent exposure to replicative cycle antigens in healthy immune donors. Clin Exp Immunol 2008;152:522-31.
12. Vafai A. Antigenicity of a candidate varicella-zoster virus glycoprotein subunit vaccine. Vaccine 1993;11:937-40.
13. Vafai A. Boosting immune response with a candidate varicella-zoster virus glycoprotein subunit vaccine. Vaccine 1995;13:1336-8.
14. Arvin AM. Humoral and cellular immunity to varicella-zoster virus: an overview. J Infect Dis 2008;197:Suppl 2:S58-S60.
15. Haumont M, Jacquet A, Massaer M, et al. Purification, characterization and immunogenicity of recombinant varicellazoster virus glycoprotein gE secreted by Chinese hamster ovary cells. Virus Res 1996;40:199-204.
16. 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.
17. Leroux-Roels I, Koutsoukos M, Clement F, et al. Strong and persistent CD4+ T-cell response in healthy adults immunized with a candidate HIV-1 vaccine containing gp120, Nef and Tat antigens formulated in three adjuvant systems. Vaccine 2010;28:7016-24.
18. Vandepapelière P, Horsmans Y, Moris P, et al. Vaccine adjuvant systems containing monophosphoryl lipid A and QS21 induce strong and persistent humoral and T cell responses against hepatitis B surface antigen in healthy adult volunteers. Vaccine 2008;26:1375-86.
19. 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;208:1953-61.
20. 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;30:3126-35.
21. 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;32:1745-53.
22. 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;206:1280-90.
23. Berkowitz EM, Moyle G, Stellbrink HJ, et al. 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.
24. 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.
25. Mols JF, Ledent E, Heineman TC. Sampling of herpes zoster skin lesion types and the impact on viral DNA detection. J Virol Methods 2013;188:145-7.
26. Oxman MN. Zoster vaccine: current status and future prospects. Clin Infect Dis 2010;51:197-213.
27. Steain M, Sutherland JP, Rodriguez M, Cunningham AL, Slobedman B, Abendroth A. Analysis of T cell responses during active varicella-zoster virus reactivation in human ganglia. J Virol 2014;88:2704-16.
28. Gowrishankar K, Steain M, Cunningham AL, et al. Characterization of the host immune response in human ganglia after herpes zoster. J Virol 2010;84:8861-70.
29. Gilbert PB, Gabriel EE, Miao X, et al. Fold rise in antibody titers by measured by glycoprotein-based enzyme-linked immunosorbent assay is an excellent correlate of protection for a herpes zoster vaccine, demonstrated via the vaccine efficacy curve. J Infect Dis 2014;210:1573-81.
30. Dorrington MG, Bowdish DM. Immunosenescence and novel vaccination strategies for the elderly. Front Immunol 2013;4:171.
31. Levin MJ. Immune senescence and vaccines to prevent herpes zoster in older persons. Curr Opin Immunol 2012;24:494-500.
32. Linton PJ, Dorshkind K. Age-related changes in lymphocyte development and function. Nat Immunol 2004;5:133-9.
33. 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.
34. Israeli E, Agmon-Levin N, Blank M, Shoenfeld Y. Adjuvants and autoimmunity. Lupus 2009;18:1217-25.
35. Tavares Da Silva F, De Keyser F, Lambert PH, Robinson WH, Westhovens R, Sindic C. Optimal approaches to data collection and analysis of potential immune mediated disorders in clinical trials of new vaccines. Vaccine 2013;31:1870-6.