Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older
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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 recombinant adjuvanted zoster vaccine, and after the second mRNA-1273 dose it was similar to that of the zoster vaccine.
“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]
The Reactogenicity section reports frequent reactions to the adjuvanted zoster vaccine and says their frequency and severity did not increase significantly after its second dose. This supports the zoster-vaccine side of the comparison, but the paper does not assess mRNA-1273 or establish that reactogenicity after its first dose was lower and after its second dose was similar. (LLM, conf=0.87)
Experimental — accuracy not yet measuredVaccination against VZV is considered an effective approach to reduce the risk of shingles.
“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]
The AS01B-adjuvanted VZV gE subunit vaccine was highly effective irrespective of age.
“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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- 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 › Epidemiology › 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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