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Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older
Open accessAbstract
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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“The degree of reactogenicity after one dose of mRNA-1273 was less than that observed for the recently approved recombinant adjuvanted zoster vaccine and after the second mRNA-1273 dose was similar to that of the zoster vaccine. 21,22”
From Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (2021) · cites this paper as [21]
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“Vaccination against VZV is considered an effective approach to reduce the risk of shingles32.”
From Algorithm for optimized mRNA design improves stability and immunogenicity (2023) · cites this paper as [32]
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“the AS01B-adjuvanted VZV gE subunit vaccine was highly effective irrespective of age”
From Successful and Maladaptive T Cell Aging (2017) · cites this paper as Cunningham et al., 2016
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Metadata
- 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
- 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
- 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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