Efficacy and safety of live varicella zoster vaccine in diabetes: a randomized, double-blind, placebo-controlled trial

Diabetic Medicine

Volumn 33, Issue 8, 2016, Pages 1094-1101

  Hata, A ^a   Inoue, F ^a   Hamamoto, Y ^a   Yamasaki, M ^a   Fujikawa, J ^a   Kawahara, H ^a   Kawasaki, Y ^a   Honjo, S ^a   Koshiyama, H ^a   Moriishi, E ^b   Mori, Y ^b,c   Ohkubo, T ^d  

^a Kitano Hospital   (Japan)

^b NATIONAL INSTITUTE OF BIOMEDICAL INNOVATION   (Japan)

^c KOBE UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^d TEIKYO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

GAMMA INTERFERON; PLACEBO; PNEUMOCOCCUS VACCINE; VARICELLA ZOSTER VACCINE;

ADULT; AGED; ARTICLE; CELLULAR IMMUNITY; CLINICAL ARTICLE; CONTROLLED STUDY; DIABETES MELLITUS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; HEMAGGLUTINATION TEST; HERPES ZOSTER; HUMAN; HUMORAL IMMUNITY; IMMUNOGENICITY; MALE; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SKIN TEST; VACCINATION; VARICELLA ZOSTER VIRUS;

EID: 84978923003     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/dme.13038     Document Type: Article

References (31)

1. Arvin AM, Moffat JF, Redman R. Varicella-zoster virus: aspects of pathogenesis and host response to natural infection and varicella vaccine. Adv Virus Res 1996; 46: 263–309.
2. Cohen JI, Brunell PA, Straus SE, Krause PR. Recent advances in varicella-zoster virus infection. Ann Intern Med 1999; 130: 922–932.
3. Dolin R, Reichman RC, Mazur MH, Whitley RJ. NIH conference. Herpes zoster-varicella infections in immunosuppressed patients. Ann Intern Med 1978; 89: 375–388.
4. Arvin AM, Pollard RB, Rasmussen LE, Merigan TC. Cellular and humoral immunity in the pathogenesis of recurrent herpes viral infections in patients with lymphoma. J Clin Invest 1980; 65: 869–878.
5. Segan J, Staples MP, March L, Lassere M, Chakravarty EF, Buchbinder R. Risk factors for herpes zoster in rheumatoid arthritis patients: the role of tumour necrosis factor-alpha inhibitors. Intern Med J 2015; 45: 310–318.
6. Izawa T, Ihara T, Hattori A, Iwasa T, Kamiya H, Sakurai M et al. Application of a live varicella vaccine in children with acute leukemia or other malignant diseases. Pediatrics 1977; 60: 805–809.
7. Takahashi M, Okada S, Miyagawa H, Amo K, Yoshikawa K, Asada H et al. Enhancement of immunity against VZV by giving live varicella vaccine to the elderly assessed by VZV skin test and IAHA, gpELISA antibody assay. Vaccine 2003; 21: 3845–3853.
8. Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 2005; 352: 2271–2284.
9. Center for Disease Control and Prevention. Update on herpes zoster vaccine: licensure for persons aged 50 through 59 years. MMWR Morb Mortal Wkly Rep 2011; 60: 1528.
10. Hales CM, Harpaz R, Ortega-Sanchez I, Bialek SR. Update on recommendations for use of herpes zoster vaccine. MMWR Morb Mortal Wkly Rep 2014; 63: 729–731. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6333a3.htm Last accessed 18 November 2015.
11. Center for Disease Control and Prevention. Herpes zoster vaccination information for health care professionals. 2014. Available at http://www.cdc.gov/vaccines/vpd-vac/shingles/hcp-vaccination.htm Last accessed 18 November 2015.
12. Gnann JW Jr, Whitley RJ. Clinical practice. Herpes zoster. N Engl J Med 2002; 347: 340–346.
13. Hata A, Kuniyoshi M, Ohkusa Y. Risk of herpes zoster in patients with underlying diseases: a retrospective hospital-based cohort study. Infection 2011; 39: 537–544.
14. Okamoto S, Hata A, Sadaoka K, Yamanishi K, Mori Y. Comparison of varicella-zoster virus-specific immunity of patients with diabetes mellitus and healthy individuals. J Infect Dis 2009; 200: 1606–1610.
15. Hata A, Inoue F, Yamasaki M, Fujikawa J, Kawasaki Y, Hamamoto Y et al. Safety, humoral and cell-mediated immune responses to herpes zoster vaccine in subjects with diabetes mellitus. J Infect 2013; 67: 215–219.
16. Wyman MJ, Stabi KL. Concomitant administration of pneumococcal–23 and zoster vaccines provides adequate herpes zoster coverage. Ann Pharmacother 2013; 47: 1064–1068.
17. Kroger AT, Atkinson WL, Marcuse EK, Pickering LK. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2006; 55: 1–48. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5515a1.htm Last accessed 18 November 2015.
18. Takahashi M, Kamiya H, Asano Y, Shiraki K, Baba K, Otsuka T et al. Immunization of the elderly to boost immunity against varicella-zoster virus (VZV) as assessed by VZV skin test reaction. Arch Virol Suppl 2001; 17: 161–172.
19. Asano Y, Shiraki K, Takahashi M, Nagai H, Ozaki T, Yazaki T. Soluble skin test antigen of varicella-zoster virus prepared from the fluid of infected cultures. J Infect Dis 1981; 143: 684–692.
20. Sadaoka K, Okamoto S, Gomi Y, Tanimoto T, Ishikawa T, Yoshikawa T et al. Measurement of varicella-zoster virus (VZV)-specific cell-mediated immunity: comparison between VZV skin test and interferon-gamma enzyme-linked immunospot assay. J Infect Dis 2008; 198: 1327–1333.
21. Yamada A, Ogino S, Asano Y, Otsuka T, Takahashi M, Baba K et al. Comparison of 4 serological tests – complement fixation, neutralization, fluorescent antibody to membrane antigen and immune adherence hemagglutination – for assay of antibody to varicella-zoster (V-Z) virus. Biken J 1979; 22: 55–60.
22. Marin M, Guris D, Chaves SS, Schmid S, Seward JF. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2007; 56: 1–40.
23. Zhao Y, Yang L, Wang X, Zhou Z. The new insights from DPP–4 inhibitors: their potential immune modulatory function in autoimmune diabetes. Diabetes Metab Res Rev 2014; 30: 646–653.
24. ® (Zoster Vaccine Live). 2006. Available at http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM285015.pdf Last accessed 18 November 2015.
25. 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: 3628–3632.
26. Levin MJ, Oxman MN, Zhang JH, Johnson GR, Stanley H, Hayward AR et al. Varicella-zoster virus-specific immune responses in elderly recipients of a herpes zoster vaccine. J Infect Dis 2008; 197: 825–835.
27. Egawa Y, Ohfuji S, Fukushima W, Yamazaki Y, Morioka T, Emoto M et al. Immunogenicity of influenza A(H1N1)pdm09 vaccine in patients with diabetes mellitus: with special reference to age, body mass index, and HbA1c. Hum Vaccin Immunother 2014; 10: 1187–1194.
28. Sasadeusz J, Prince HM, Schwarer A, Szer J, Stork A, Bock HL et al. Immunogenicity and safety of a two-dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation. Transpl Infect Dis 2014; 16: 1024–1031.
29. 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: 160–166.
30. Leroux-Roels I, Leroux-Roels G, Clement F, Vandepapeliere P, Vassilev V, Ledent E 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: 1280–1290.
31. Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med 2015; 372: 2087–2096.