Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older

New England Journal of Medicine

Volumn 375, Issue 11, 2016, Pages 1019-1032

  Cunningham, A L ^a,b   Lal, H ^f   Kovac, M ^g   Chlibek, R ^h   Hwang, S J ⁱ   Diez Domingo J ^j   Godeaux, O ^g   Levin, M J ^k   McElhaney, J E ^l   Puig Barbera J ^j   Vanden Abeele, C ^g   Vesikari, T ^p   Watanabe, D ^q   Zahaf, T ^g   Ahonen, A ⁿ   Athan, E ^c   Barba Gomez, J F ^r   Campora, L ^g   De Looze, F ^d   Downey, H J ^s   Ghesquiere, W ^m   Gorfinkel, I ^m   Korhonen, T ^p   Leung, E ^t   McNeil, S A ^o   Oostvogels, L ^g   Rombo, L ^u   Smetana, J ^h   Weckx, L ^v   Yeo, W ^e   Heineman, T C ^f,w   more..

^a WESTMEAD HOSPITAL   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c DEAKIN UNIVERSITY   (Australia)

^d UNIVERSITY OF QUEENSLAND   (Australia)

^e UNIVERSITY OF WOLLONGONG   (Australia)

^f GLAXOSMITHKLINE   (United States)

^g GSK   (Belgium)

^h UNIVERSITY OF DEFENCE   (Czech Republic)

ⁱ TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

^j Fundacion para el Fomento de la Investigacion Sanitaria y Biomedica de la Comunitat Valenciana   (Spain)

^k UNIVERSITY OF COLORADO   (United States)

^l HEALTH SCIENCES NORTH   (Canada)

^m UNIVERSITY OF BRITISH COLUMBIA   (Canada)

ⁿ PrimeHealth Clinical Research Organization   (Canada)

^o DALHOUSIE UNIVERSITY   (Canada)

^p TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^q AICHI MEDICAL UNIVERSITY   (Japan)

^r INSTITUTO DERMATOLÓGICO DE JALISCO DR JOSÉ BARBA RUBIO   (Mexico)

^s Jacksonville Center for Clinical Research   (United States)

^t UNITED CHRISTIAN HOSPITAL   (Hong Kong)

^u UPPSALA UNIVERSITY   (Sweden)

^v FEDERAL UNIVERSITY OF SÃO PAULO   (Brazil)

^w Cambridge Discovery Park   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; VARICELLA ZOSTER VACCINE; SUBUNIT VACCINE;

ACUTE MYELOBLASTIC LEUKEMIA; ADULT; AGED; ARTICLE; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HERPES ZOSTER; HUMAN; INCIDENCE; INFECTION RISK; INJECTION SITE PAIN; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; NEUTROPENIA; PHASE 3 CLINICAL TRIAL; POSTHERPETIC NEURALGIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REPEATED DRUG DOSE; RISK REDUCTION; SEPSIS; SHIVERING; SKIN REDNESS; TREATMENT OUTCOME; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; IMMUNOLOGY; KAPLAN MEIER METHOD; MIDDLE AGED; NEURALGIA, POSTHERPETIC; RISK; VERY ELDERLY;

AGED; AGED, 80 AND OVER; DOUBLE-BLIND METHOD; FEMALE; HERPES ZOSTER; HERPES ZOSTER VACCINE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEURALGIA, POSTHERPETIC; RISK; VACCINES, SUBUNIT;

EID: 84988446438     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1603800     Document Type: Article

References (33)

1. Cohen JI. Herpes zoster. N Engl J Med 2013;369:255-63.
2. Harpaz R, Ortega-Sanchez IR, Seward JF. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008;57(RR-5):1-30.
3. Cunningham AL, Dworkin RH. The management of post-herpetic neuralgia. BMJ 2000;321:778-9.
4. Johnson RW, Rice ASC. Postherpetic neuralgia. N Engl J Med 2014; 371: 1526-33.
5. Drolet M, Brisson M, Schmader KE, et al. The impact of herpes zoster and postherpetic neuralgia on health-related quality of life: a prospective study. CMAJ 2010;182:1731-6.
6. Duracinsky M, Paccalin M, Gavazzi G, et al. ARIZONA study: is the risk of post-herpetic neuralgia and its burden increased in the most elderly patients? BMC Infect Dis 2014;14:529.
7. 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.
8. Pinchinat S, Cebrián-Cuenca AM, Bri-cout H, Johnson RW. Similar herpes zos-ter incidence across Europe: results from a systematic literature review. BMC Infect Dis 2013;13:170.
9. Insinga RP, Itzler RF, Pellissier JM, Saddier P, Nikas AA. The incidence of herpes zoster in a United States administrative database. J Gen Intern Med 2005; 20: 748-53.
10. 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.
11. Kawai K, Rampakakis E, Tsai TF, et al. Predictors of postherpetic 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.
12. Johnson RW, McElhaney J. Posther-petic neuralgia in the elderly. Int J Clin Pract 2009;63:1386-91.
13. 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.
14. McDonald EM, de Kock J, Ram FS. Antivirals for management of herpes zoster including ophthalmicus: a systematic review of high-quality randomized con-trolled trials. Antivir Ther 2012; 17: 255-64.
15. Bruxelle J, Pinchinat S. Effectiveness of antiviral treatment on acute phase of herpes zoster and development of post herpetic neuralgia: review of international publications. Med Mal Infect 2012; 42: 53-8.
16. Whitley RJ, Volpi A, McKendrick M, Wijck Av, Oaklander AL. Management of herpes zoster and post-herpetic neuralgia now and in the future. J Clin Virol 2010; 48:Suppl 1:S20-8.
17. Chen N, Li Q, Yang J, Zhou M, Zhou D, He L. Antiviral treatment for preventing postherpetic neuralgia. Cochrane Database Syst Rev 2014; 2: CD006866.
18. Update on herpes zoster vaccine: li-censure for persons aged 50 through 59 years. MMWR Morb Mortal Wkly Rep 2011;60:1528.
19. 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.
20. 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: 863-8.
21. Stadtmauer EA, Sullivan KM, Marty FM, et al. A phase 1/2 study of an adju-vanted varicella-zoster virus subunit vac-cine in autologous hematopoietic cell transplant recipients. Blood 2014; 124: 2921-9.
22. 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.
23. 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.
24. 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.
25. 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, ran-domized, controlled study. Vaccine 2014; 32: 1745-53.
26. 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: 2087-96.
27. Coplan PM, Schmader K, Nikas A, et al. Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. J Pain 2004;5:344-56.
28. Schmader K, Gnann JW Jr, Watson CP. The epidemiological, clinical, and pathological rationale for the herpes zoster vaccine. J Infect Dis 2008; 197: Suppl 2: S207-15.
29. Prince MJ, Wu F, Guo Y, et al. The burden of disease in older people and implications for health policy and practice. Lancet 2015;385:549-62.
30. Arvin AM. Immune responses to vari-cella-zoster virus. Infect Dis Clin North Am 1996;10:529-70.
31. Arvin AM. Humoral and cellular immunity to varicella-zoster virus: an overview. J Infect Dis 2008; 197: Suppl 2: S58-60.
32. 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.
33. The RTS, S Clinical Trials Partnership. A phase 3 trial of RTS, S/AS01 malaria vaccine in African infants. N Engl J Med 2012;367:2284-95.