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The live attenuated vaccine Zostavax was developed to prevent varicella zoster virus (VZV) reactivation that causes herpes zoster (shingles) in older humans. However, the impact of vaccination on the cutaneous response to VZV is not known. We investigated the response to intradermal VZV antigen challenge before and after Zostavax vaccination in participants >70 years of age by immunohistological and transcriptomic analyses of skin biopsy specimens collected from the challenge site. Vaccination increased the proportion of VZV-specific CD4+ T cells in the blood and promoted the accumulation of both CD4+ and CD8+ T cells in the skin after VZV antigen challenge. However, Zostavax did not alter the proportion of resident memory T cells (CD4+ and CD8+) or CD4+Foxp3+ regulatory T cells in unchallenged skin. After vaccination, there was increased cutaneous T-cell proliferation at the challenge site and also increased recruitment of T cells from the blood, as indicated by an elevated T-cell migratory gene signature. CD8+ T-cell-associated functional genes were also highly induced in the skin after vaccination. Zostavax vaccination does not alter the abundance of cutaneous resident memory T cells but instead increases the recruitment of VZV-specific T cells from the blood and enhances T-cell activation, particularly cells of the CD8+ subset, in the skin after VZV antigen challenge.

In 2016, the live attenuated zoster vaccine (Zostavax, Merck and Co, USA) was introduced into the Australian National Immunisation Program for people aged 70 years who are not significantly immunocompromised. We report the administration of Zostavax in an immunocompromised patient with chronic lymphocytic leukaemia and no evidence of primary varicella zoster virus (VZV) infection. The patient presented with a bilateral vesicular facial rash 22 days after receiving Zostavax and was initially managed as an outpatient with oral acyclovir. He re-presented three days later and was diagnosed with disseminated VZV infection complicated by meningoencephalitis. The patient died following cardiac arrest on day 10 of hospitalisation. This unfortunate case highlights the challenge of safely implementing a high titre live vaccine in a population where contraindications are prevalent. The non-live recombinant herpes zoster subunit vaccine (Shingrix, GSK) may provide a safe and effective option to protect immunocompromised patients from shingles and post-herpetic neuralgia.

Immunisation against herpes zoster is recommended for adults aged ≥ 50 years. Two vaccines, a live attenuated (ZVL, Zostavax®) and an adjuvant recombinant subunit (HZ/su, Shingrix®), are available in Australia. Immunisation guidelines are shifting their recommendations towards HZ/su because of higher efficacy in preventing herpes zoster and associated complications. However, there are limited post-marketing data comparing the safety profiles of these vaccines. Data from SmartVax, an active surveillance system for monitoring adverse events following immunisation (AEFIs) utilised by > 450 clinics throughout Australia, were analysed. Data from patients aged ≥ 50 years, who received ZVL or HZ/su, from 1 June 2021 to 31 May 2022, at clinics that utilised SmartVax were included. The proportion of records where patients who reported any, local, and systemic AEFIs after receiving ZVL or HZ/su were compared using multivariable logistic regression models. Data from 10,392 immunisation records (n = 8341 ZVL; n = 2051 HZ/su) were included. The proportion of AEFIs reported was higher with HZ/su (41.9 % [any], 33.8 % [local], 25.2 % [systemic]) than with ZVL (8.7 % [any], 6.2 % [local], 3.5 % [systemic]). After controlling for demographic variables, HZ/su presented a 6-fold increase in the odds (OR 6.44; 95 %CI: 5.57–7.46) of a reported AEFI compared to ZVL. Only 59 (0.6 %) of vaccinations lead to medical attention being sought due to an AEFI. While rates of AEFIs was higher with HZ/su than ZVL, most AEFIs were mild and did not require medical attention. Our findings support the change in vaccine recommendations and the use of HZ/su in immunisation programs.

While the adjuvanted recombinant zoster vaccine (RZV) is preferred for herpes zoster (HZ) prevention due to its superior efficacy, emerging evidence suggests a potentially elevated reactogenicity risk relative to the live attenuated zoster vaccine (ZVL). This research aims to further assess the safety profiles of both vaccines, particularly the risk of serious adverse events following immunization (AEFIs) to provide more evidence for clinical decision. Individual case safety reports from the Vaccine Adverse Event Reporting System (May 2006–December 2024) were analyzed. Descriptive and time-to-onset (TTO) analyses were performed by vaccine type and AEFI seriousness. Disproportionality analyses were conducted at the System Organ Class, High-Level Term, and Preferred Term (PT) levels, with PT signals prioritized by the Designated Medical Event and Important Medical Event criteria. Additionally, three adverse events of special interest—anaphylactic reaction, Guillain-Barré syndrome (GBS) and syncope, were assessed using Standardized MedDRA Queries if available. For monotherapy ICSRs (>90 % of total), serious AEFIs occurred in 11.2 % of ZVL and 4.6 % of RZV recipients, with fatal outcomes documented in 0.5 % and 0.3 % of cases respectively. The majority of ICSRs for both vaccines originated from the US, with ZVL cases primarily recorded prior to 2017. For both vaccines, females and individuals aged 60–69 years predominated among reported cases; patients experiencing serious AEFIs were generally older. Most AEFIs occurred ≤7 days post-vaccination (peak: 0–2 days). Serious AEFIs occurred later than non-serious events. RZV-associated AEs primarily manifested as transient reactogenicity, whereas ZVL showed stronger associations with HZ reactivation along with neurological and ophthalmic complications. Neither vaccine exhibited disproportionality signals for anaphylaxis or syncope. However, GBS signals were inconsistent for RZV(detected by 2/4 methodologies), warranting further investigation to clarify potential safety implications. These findings provide reassuring real-world evidence supporting RZV's clinical safety.

The adjuvanted herpes zoster subunit vaccine candidate induces strong humoral and cellular immune responses irrespective of prior vaccination with the live attenuated zoster vaccine (ZVL), and may be an attractive option to revaccinate prior ZVL recipients. Abstract Background Protection against herpes zoster (HZ) induced by the live attenuated zoster vaccine Zostavax (ZVL) wanes within 3–7 years. Revaccination may renew protection. We assessed whether (re)vaccination with the adjuvanted HZ subunit vaccine candidate (HZ/su) induced comparable immune responses in previous ZVL recipients and ZVL-naive individuals (HZ-NonVac). Methods In an open-label, multicenter study, adults ≥65 years of age, vaccinated with ZVL ≥5 years previously (HZ-PreVac), were matched to ZVL-naive adults (HZ-NonVac). Participants received 2 doses of HZ/su 2 months apart. The primary objective of noninferiority of the humoral immune response 1 month post–dose 2 was considered demonstrated if the upper limit of the 95% confidence interval (CI) of the adjusted anti–glycoprotein E geometric mean concentration (GMC) ratio of HZ-NonVac over HZ-PreVac was <1.5. HZ/su cellular immunogenicity, reactogenicity, and safety were also assessed. Results In 430 participants, humoral immune response to HZ/su was noninferior in HZ-PreVac compared with HZ-NonVac (adjusted GMC ratio, 1.04 [95% CI, .92–1.17]). Cellular immunogenicity, reactogenicity, and safety appeared to be comparable between groups. HZ/su was well-tolerated, with no safety concerns raised within 1 month post–dose 2. Conclusions HZ/su induces a strong immune response irrespective of prior vaccination with ZVL, and may be an attractive option to revaccinate prior ZVL recipients. Clinical Trials Registration NCT02581410.

Using Super Learner, a machine learning statistical method, we assessed varicella zoster virus-specific glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) antibody titer as an individual-level signature of herpes zoster (HZ) risk in the Zostavax Efficacy and Safety Trial. Gender and pre- and postvaccination gpELISA titers had moderate ability to predict whether a 50-59 year old experienced HZ over 1-2 years of follow-up, with equal classification accuracy (cross-validated area under the receiver operator curve = 0.65) for vaccine and placebo recipients. Previous analyses suggested that fold-rise gpELISA titer is a statistical correlate of protection and supported the hypothesis that it is not a mechanistic correlate of protection. Our results also support this hypothesis.

A 49-year-old kidney transplant recipient, presented with a skin rash, and interstitial infiltrates three weeks after receiving a live attenuated varicella-zoster vaccine. Varicella-zoster Oka-vaccine strain was detected in plasma by polymerase chain reaction and sequencing analysis targeting open reading frame 62 (ORF 62). She was treated successfully with intravenous acyclovir. Our case report supports the current contraindication of live attenuated varicella-zoster vaccine in the solid-organ transplant recipients. Recombinant subunit varicella-zoster vaccine may be the vaccine of choice in these patients; nevertheless, further information is required to establish its safety, efficacy, and optimal timing.

ZOSTAVAX(®) is a live attenuated varicella-zoster virus (VZV) vaccine that is licensed for the protection of individuals ≥50 years against shingles and its most common complication, postherpetic neuralgia. While IFNγ responses increase upon vaccination, the quality of the T cell response has not been elucidated. By using polychromatic flow cytometry, we characterized the breadth, magnitude, and quality of ex vivo CD4(+) and CD8(+) T cell responses induced 3-4 weeks after ZOSTAVAX vaccination of healthy adults. We show, for the first time that the highest frequencies of VZV-specific CD4(+) T cells were poly-functional CD154(+)IFNγ(+)IL-2(+)TNFα(+) cells, which were boosted upon vaccination. The CD4(+) T cells were broadly reactive to several VZV proteins, with immediate early (IE) 63 ranking the highest among them in the fold rise of poly-functional cells, followed by IE62, gB, open reading frame (ORF) 9, and gE. We identified a novel poly-functional ORF9-specific CD8(+) T cell population in 62% of the subjects, and these were boosted upon vaccination. Poly-functional CD4(+) and CD8(+) T cells produced significantly higher levels of IFNγ, IL-2, and TNFα compared to mono-functional cells. After vaccination, a boost in the expression of IFNγ by poly-functional IE63- and ORF9-specific CD4(+) T cells and IFNγ, IL-2, and TNFα by ORF9-specific poly-functional CD8(+) T cells was observed. Responding poly-functional T cells exhibited both effector (CCR7(-)CD45RA(-)CD45RO(+)), and central (CCR7(+)CD45RA(-)CD45RO(+)) memory phenotypes, which expressed comparable levels of cytokines. Altogether, our studies demonstrate that a boost in memory poly-functional CD4(+) T cells and ORF9-specific CD8(+) T cells may contribute toward ZOSTAVAX efficacy.

Herpes Zoster (HZ) is a viral skin disease caused by reactivation of latent Varicella Zoster Virus (VZV) in human ganglia, presenting with unilateral neuropathic pain and vesicular rash. HZ imposes significant burden on patients and healthcare systems, often complicated by postherpetic neuralgia (PHN). The live attenuated zoster vaccine (ZVL, Zostavax) reduces HZ risk by 51% and PHN by 65% in adults ≥60 years. The recombinant zoster vaccine (RZV, Shingrix) shows approximately 90% efficacy in adults ≥50 years. Despite withdrawal of Zostavax from the U.S. market, RZV uptake remains suboptimal due to vaccine hesitancy and provider knowledge gaps. This study aims to analyze global research trends on HZ vaccines using bibliometric methods. Publications on \"herpes zoster\" and \"zoster vaccine\" were retrieved from the Web of Science Core Collection (WoSCC) database (1999-2024). Bibliometric and visualization tools including CiteSpace, VOSviewer, and R-bibliometrix were applied to analyze contributions by countries, institutions, journals, authors, references, and keywords. A total of 719 articles from 261 journals across 56 countries were included. The United States led publications, with GlaxoSmithKline (GSK) as the most prolific institution. was the most prolific journal; Levin et al. was the most productive author. The most cited article, \"Efficacy of the Herpes Zoster Subunit Vaccine in Adults Aged 70 Years or Older,\" by Cunningham AL, appeared in the . Frequently used keywords included \"herpes zoster,\" \"vaccination,\" \"postherpetic neuralgia,\" \"efficacy,\" \"subunit vaccine,\" and \"safety\". This bibliometric study comprehensively summarizes HZ vaccine research over 25 years, offering insights to guide future research and clinical practice.

The objective of this study was to estimate the effectiveness of the herpes zoster vaccine Zostavax in a cohort of vaccinated individuals in Sweden. The study is a retrospective population-based matched cohort study conducted with data from health care registers in Stockholm Country. Primary endpoints were new diagnosis of HZ after administration of Zostavax. Individuals above the age of 50 years and living in Stockholm County in 2013 were included into the study. Ten non-vaccinated individuals per vaccinated were included and randomized into the cohort. The non-vaccinated were matched on age at index date and gender. Zostavax had an overall effectiveness (VE) of 34% (HR = 0.66, 95% CI: 0.55–0.78). When stratifying by age, 61–75 years was the only age group that showed a reduced risk of HZ (HR = 0.57; CI 0.44–0.73) compared to those that were non-vaccinated. As compared to the unvaccinated group, the VE was significant at days 180–359 (HR = 0.53; 95% CI 0.33–0.88), 360–539 (HR = 0.46; 95% CI 0.27–0.80) and at days 540–719 (HR = 0.56; 95% CI 0.35–0.90) after vaccination. This is the first population-based study in Sweden studying the effectiveness of HZ vaccination. Our findings are well in-line with previous studies, however studies addressing the longitudinal efficacy and effectiveness of Zostavax are still required.