Cited by 1,070Herpesvirus Infections and TreatmentsCytomegalovirus and herpesvirus researchVirology and Viral Diseases

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Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

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Cunningham, Anthony L., Lal, Himal, Kovac, Martina, Chlibek, Roman, Hwang, Shinn-Jang, Díez-Domingo, Javier, Godeaux, Olivier, Levin, Myron J., McElhaney, Janet E., Puig-Barberà, Joan, Vanden Abeele, Carline, Vesikari, Timo, Watanabe, Daisuke, Zahaf, Toufik, Ahonen, Anitta, Athan, Eugene, Barba-Gomez, Jose F., Campora, Laura, de Looze, Ferdinandus, Downey, H. Jackson, Ghesquiere, Wayne, Gorfinkel, Iris, Korhonen, Tiina, Leung, Edward, McNeil, Shelly A., Oostvogels, Lidia, Rombo, Lars, Smetana, Jan, Weckx, Lily, Yeo, Wilfred, Heineman, Thomas C.·2016·New England Journal of Medicine

DOI 10.1056/nejmoa1603800

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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 .).

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Authors: Cunningham, A. L., Lal, H., Kovac, M., Chlibek, R., Hwang, S.-J., Díez-Domingo, J., Godeaux, O., Levin, M. J., McElhaney, J. E., Puig-Barberà, J., Vanden Abeele, C., Vesikari, T., Watanabe, D., Zahaf, T., Ahonen, A., Athan, E., Barba-Gomez, J. F., Campora, L., de Looze, F., Downey, H. J., Ghesquiere, W., Gorfinkel, I., Korhonen, T., Leung, E., McNeil, S. A., Oostvogels, L., Rombo, L., Smetana, J., Weckx, L., Yeo, W., & Heineman, T. C.
Affiliations: The University of Sydney (AU)
Uppsala University (SE)
ORCID: Cunningham, Anthony L.
Lal, Himal
Hwang, Shinn-Jang
Godeaux, Olivier
Levin, Myron J.
McElhaney, Janet E.
Watanabe, Daisuke
Zahaf, Toufik
Athan, Eugene
de Looze, Ferdinandus
Gorfinkel, Iris
McNeil, Shelly A.
Oostvogels, Lidia
Rombo, Lars
Smetana, Jan
Weckx, Lily
Yeo, Wilfred
Heineman, Thomas C.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2016-09-15
Volume: 375
Issue: 11
Pages: 1019-1032
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1603800
OpenAlex: W2519957152
Cited by: 1,070
References: 31
Citations by year: 2026: 96 · 2025: 124 · 2024: 107 · 2023: 97 · 2022: 91 · 2021: 120 · 2020: 94 · 2019: 117 · 2018: 138 · 2017: 75 · 2016: 11
FWCI: 106.61
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Research Online (University of Wollongong) (submittedVersion)
Figshare (submittedVersion, cc-by)
CINECA IRIS Institutial Research Information System (University of Genoa) (submittedVersion)
Funders: Bristol-Myers Squibb
Pfizer
AstraZeneca
Sanofi
Novo Nordisk
Astellas Pharma
H. Lundbeck A/S
Sanofi Pasteur
Topics: Health Sciences › Medicine › Infectious Diseases › Herpesvirus Infections and Treatments
Health Sciences › Medicine › Epidemiology › Cytomegalovirus and herpesvirus research
Health Sciences › Medicine › Epidemiology › Virology and Viral Diseases
Keywords: herpes zoster, postherpetic neuralgia, vaccine efficacy, older adults, AS01B adjuvant, vaccine safety, herpes zoster incidence, vaccine adverse events, immunosenescence, immunogenicity
MeSH terms: Aged, Aged, 80 and over, Double-Blind Method, Female, Herpes Zoster, Humans, Male, Middle Aged, Risk, Vaccines, Subunit, Neuralgia, Postherpetic, Herpes Zoster Vaccine, Kaplan-Meier Estimate

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Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

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