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

Journal Article


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Abstract


  • BACKGROUND

    A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella–zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70).

    METHODS

    This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50.

    RESULTS

    In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70

    (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups.

    CONCLUSIONS

    In our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. (Funded by GlaxoSmithKline Biologicals; ZOE-50 and ZOE-70 ClinicalTrials.gov numbers, NCT01165177 and NCT01165229.)

UOW Authors


  •   Cunningham, A L (external author)
  •   Lal, Himal (external author)
  •   Kovac, Martina (external author)
  •   Chlibek, Roman (external author)
  •   Hwang, Shinn-Jang (external author)
  •   Diez-Domingo, Javier (external author)
  •   Godeaux, Olivier (external author)
  •   Levin, Myron J. (external author)
  •   Mcelhaney, Janet E. (external author)
  •   Puig-Barbera, Joan (external author)
  •   Yeo, Wilfred

Publication Date


  • 2016

Citation


  • Cunningham, A. L., Lal, H., Kovac, M., Chlibek, R., Hwang, S., Diez-Domingo, J., Godeaux, O., Levin, M. J., Mcelhaney, J. E., Puig-Barbera, J. & Yeo, W. (2016). Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. The New England Journal of Medicine, 375 (11), 1019-1032.

Scopus Eid


  • 2-s2.0-84988446438

Ro Full-text Url


  • http://ro.uow.edu.au/cgi/viewcontent.cgi?article=1952&context=ihmri

Ro Metadata Url


  • http://ro.uow.edu.au/ihmri/927

Has Global Citation Frequency


Number Of Pages


  • 13

Start Page


  • 1019

End Page


  • 1032

Volume


  • 375

Issue


  • 11

Place Of Publication


  • United States

Abstract


  • BACKGROUND

    A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella–zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70).

    METHODS

    This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50.

    RESULTS

    In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70

    (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups.

    CONCLUSIONS

    In our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. (Funded by GlaxoSmithKline Biologicals; ZOE-50 and ZOE-70 ClinicalTrials.gov numbers, NCT01165177 and NCT01165229.)

UOW Authors


  •   Cunningham, A L (external author)
  •   Lal, Himal (external author)
  •   Kovac, Martina (external author)
  •   Chlibek, Roman (external author)
  •   Hwang, Shinn-Jang (external author)
  •   Diez-Domingo, Javier (external author)
  •   Godeaux, Olivier (external author)
  •   Levin, Myron J. (external author)
  •   Mcelhaney, Janet E. (external author)
  •   Puig-Barbera, Joan (external author)
  •   Yeo, Wilfred

Publication Date


  • 2016

Citation


  • Cunningham, A. L., Lal, H., Kovac, M., Chlibek, R., Hwang, S., Diez-Domingo, J., Godeaux, O., Levin, M. J., Mcelhaney, J. E., Puig-Barbera, J. & Yeo, W. (2016). Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. The New England Journal of Medicine, 375 (11), 1019-1032.

Scopus Eid


  • 2-s2.0-84988446438

Ro Full-text Url


  • http://ro.uow.edu.au/cgi/viewcontent.cgi?article=1952&context=ihmri

Ro Metadata Url


  • http://ro.uow.edu.au/ihmri/927

Has Global Citation Frequency


Number Of Pages


  • 13

Start Page


  • 1019

End Page


  • 1032

Volume


  • 375

Issue


  • 11

Place Of Publication


  • United States