Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults
Open accessAbstract
BACKGROUND: In previous phase 1-2 clinical trials involving older adults, a subunit vaccine containing varicella-zoster virus glycoprotein E and the AS01B adjuvant system (called HZ/su) had a clinically acceptable safety profile and elicited a robust immune response. METHODS: We conducted a randomized, placebo-controlled, phase 3 study in 18 countries to evaluate the efficacy and safety of HZ/su in older adults (≥50 years of age), stratified according to age group (50 to 59, 60 to 69, and ≥70 years). Participants received two intramuscular doses of the vaccine or placebo 2 months apart. The primary objective was to assess the efficacy of the vaccine, as compared with placebo, in reducing the risk of herpes zoster in older adults. RESULTS: A total of 15,411 participants who could be evaluated received either the vaccine (7698 participants) or placebo (7713 participants). During a mean follow-up of 3.2 years, herpes zoster was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group (incidence rate, 0.3 vs. 9.1 per 1000 person-years) in the modified vaccinated cohort. Overall vaccine efficacy against herpes zoster was 97.2% (95% confidence interval [CI], 93.7 to 99.0; P<0.001). Vaccine efficacy was between 96.6% and 97.9% for all age groups. Solicited reports of injection-site and systemic reactions within 7 days after vaccination were more frequent in the vaccine group. There were solicited or unsolicited reports of grade 3 symptoms in 17.0% of vaccine recipients and 3.2% of placebo recipients. The proportions of participants who had serious adverse events or potential immune-mediated diseases or who died were similar in the two groups. CONCLUSIONS: The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older. Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups. (Funded by GlaxoSmithKline Biologicals; ZOE-50 ClinicalTrials.gov number, NCT01165177.).
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The novel inactivated herpes zoster vaccine containing glycoprotein E adjuvanted with AS01B has clinical efficacy of 97.2% against herpes zoster for persons over age 50 and did not decrease for older age groups (>70 years).
“In a phase III randomized placebo-controlled trial clinical efficacy against herpes zoster was 97.2% (95% CI: 93.7–99.0, p<0.001) for persons over the age of 50 and did not decrease for older age groups (>70 years) [171].”
From Aging of the immune system: Focus on inflammation and vaccination (2016) · cites this paper as [171]
The addition of PAMPs to a subunit vaccine, triggering their corresponding pattern-recognition receptors (e.g., TLRs), improves vaccine efficacy in older humans and mice.
“On the other hand, the addition of PAMPs to a subunit vaccine, triggering their corresponding pattern-recognition receptors (e.g., TLRs) improves vaccine efficacy in older humans and mice (25, 30–32).”
From Immunosenescence and Its Hallmarks: How to Oppose Aging Strategically? A Review of Potential Options for Therapeutic Intervention (2019) · cites this paper as [31]
Emerging data following the recent development and deployment of new-generation, high-dose or adjuvanted influenza vaccines and an adjuvanted glycoprotein varicella zoster vaccine suggest that the provision of additional signals to the immune system by certain adjuvants (such as AS01 and MF59) can overcome immunosenescence.
“emerging data following the recent development and deployment of new-generation, high-dose or adjuvanted influenza vaccines82 and an adjuvanted glycoprotein varicella zoster vaccine83 suggest that the provision of additional signals to the immune system by certain adjuvants (such as AS01 and MF59) can overcome immunosenescence.”
From A guide to vaccinology: from basic principles to new developments (2021) · cites this paper as [83]
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Self-citation
- Authors
- Lal, H., Cunningham, A. L., Godeaux, O., Chlibek, R., Diez-Domingo, J., Hwang, S.-J., Levin, M. J., McElhaney, J. E., Poder, A., Puig-Barberà, J., Vesikari, T., Watanabe, D., Weckx, L., Zahaf, T., & Heineman, T. C.
- Affiliations
- Westmead Institute for Medical Research (AU)
- The University of Sydney (AU)
- GlaxoSmithKline (Belgium) (BE)
- Taipei Veterans General Hospital (TW)
- University of Colorado Anschutz (US)
- Tampere University (FI)
- Aichi Medical University (JP)
- Universidade Federal de São Paulo (BR)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-05-28
- Volume
- 372
- Issue
- 22
- Pages
- 2087-2096
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2010207831
- Cited by
- 1,454
- References
- 34
- Citations by year
- 2026: 132 · 2025: 151 · 2024: 136 · 2023: 117 · 2022: 115 · 2021: 154 · 2020: 108 · 2019: 148 · 2018: 148 · 2017: 109 · 2016: 104 · 2015: 31
- FWCI
- 102.45
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Tampere University Institutional Repository (Tampere University) (publishedVersion)
- Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion)
- UNIFESP Institutional Repository (Universidade Federal de São Paulo) (submittedVersion)
- Tampere University Institutional Repository (Tampere University) (submittedVersion)
- 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 vaccine, varicella-zoster virus, glycoprotein E, AS01B adjuvant, subunit vaccine, older adults, vaccine efficacy, vaccine safety, age-stratified analysis, herpes zoster incidence, adverse events
- MeSH terms
- Adjuvants, Immunologic, Aged, Double-Blind Method, Female, Herpes Zoster, Humans, Injections, Intramuscular, Male, Middle Aged, Treatment Outcome, Vaccines, Subunit, Herpes Zoster Vaccine
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