Incidence Of Zoster Research Articles

Post COVID-19 Immunization Herpes Zoster Reactivation In Asia : A Literature Review

Background: The COVID-19 vaccine that targets viral mRNA has been created and can be used as an effort to end the COVID-19 pandemic that has hit the world since 2020. The COVID-19 vaccine currently being developed has proven its effectiveness and safety in the general adult population.Objective: To identify reactivation of Herpes Zoster virus post COVID-19 vaccine.Methods: This article review discusses four case reports of Herpes Zoster following the COVID-19 immunization in Asia which were obtained from various sources such as Pubmed Medline Embase.Results: The mRNA-type vaccine is associated with skin manifestations with an increased incidence (14.4%) of Herpes Zoster which was observed around 6-8 days after administration of the first dose of vaccine (BNT162b2 vaccine) and 1.5% after administration of the mRNA- 1273 which occurred in the Asian Oceanian race. COVID-19 vaccine substances such as polyethylene glycol (PEG), the polysorbate present in mRNA vaccines, and polysorbate 80 are suspected causing an allergic reactions.Conclusion: Health workers must be careful in administering the COVID-19 vaccine, especially to individuals who have risk factors that can decrease their immune system so it can cause reactivation of Herpes Zoster.

The Association between Varicella Vaccination and Herpes Zoster in Children: A Semi-National Retrospective Study.

Varicella vaccination in children has been performed worldwide in recent years. Despite established effectiveness, many countries still do not routinely vaccinate children against varicella, probably due to concerns about complications, such as herpes zoster infection. We aimed to compare the herpes zoster incidence in children before and after implementing the mandatory varicella vaccine in Israel in 2008. As a secondary aim, we characterized several parameters, including age, sex, and ethnic sector among herpes zoster cases, and we evaluated the complication rate to identify data relevant to the immunization status of the pediatric population. A retrospective study was conducted between 2000 and 2021, including patients aged 0-18 years old in a large cohort in southern Israel. A time series analysis and complication rates evaluations were performed in the pre- and post-vaccination eras. A total of 109.24 herpes zoster cases per 100,000 population per year were diagnosed between 2000 and 2007 (pre-vaccination era), compared to 354.71 herpes zoster cases per 100,000 population per year diagnosed between 2008 and 2021 (post-vaccination era) (p < 0.001). No change in the complication rate was documented. Thus, we concluded that there is an association between the varicella vaccine implementation program and the increase in the rate of herpes-zoster occurrence without a concurrent negative contribution to herpes zoster-related morbidity.

Impacts of routine varicella vaccination program and COVID-19 pandemic on varicella and herpes zoster incidence and health resource use among children in Japan

PurposeTo determine the epidemiological trends in pediatric varicella and herpes zoster incidence and changes in healthcare resource use from 2005 to 2022 using a nationally representative database in Japan. Materials and methodsWe conducted a retrospective observational study consisting of 3.5 million children with 177 million person-months during 2005–2022 using Japan Medical Data Center (JMDC) claims database in Japan. We investigated trends in incidence rates of varicella and herpes zoster and changes in healthcare resource use (e.g., antiviral use, office visits, and healthcare costs) over 18 years. Interrupted time-series analyses were used to investigate the impact of the routine varicella vaccination program in 2014 and infection prevention measures against COVID-19 on incidence rates of varicella and herpes zoster and related healthcare utilization. ResultsAfter the introduction of the routine immunization program in 2014, we observed level changes in incidence rates (45.6 % reduction [95 %CI, 32.9–56.0] of varicella cases, antiviral use (40.9 % reduction [95 %CI, 25.1–53.3]), and relevant healthcare costs (48.7 % reduction [95 %CI, 38.2–57.3]). Furthermore, infection prevention measures against COVID-19 were associated with additional level changes in varicella rates (57.2 % reduction [95 %CI, 44.5–67.1]), antiviral use (65.7 % reduction [59.7–70.8]), and healthcare costs (49.1 % [95 %CI, 32.7–61.6]). In contrast, the changes in incidence and healthcare costs for herpes zoster were relatively small, which showed 9.4 % elevated level change with a decreasing trend and 8.7 % reduced level change with a decreasing trend after the vaccine program and the COVID-19 pandemic. The cumulative incidence of herpes zoster in children born after 2014 was lower than that before 2014. ConclusionsVaricella incidence and healthcare resource use were largely affected by the routine immunization program and infection prevention measures against COVID-19, while these impacts on herpes zoster were relatively small. Our study indicates that immunization and infection prevention measures largely changed pediatric infectious disease practices.

Post-licensure safety study of new-onset immune-mediated diseases, herpes zoster, and anaphylaxis in adult recipients of HepB-CpG vaccine versus HepB-alum vaccine

BackgroundHepB-CpG (Heplisav-B) is a licensed hepatitis B vaccine with a novel adjuvant that requires 2 doses (0, 1 month) compared to HepB-alum (Engerix-B) which requires 3 doses (0, 1, 6 months). Monitoring safety outcomes following receipt of vaccines with novel adjuvants outside trial settings is important. Hence, as part of a post-marketing commitment, we compared the incidence of new-onset immune-mediated diseases, herpes zoster (HZ), and anaphylaxis among recipients of HepB-CpG versus HepB-alum. MethodsThis cohort study included adults not on dialysis who received ≥1 dose of hepatitis B vaccine from 8/7/2018 to 10/31/2019, during which HepB-CpG was routinely administered in 7 of 15 Kaiser Permanente Southern California medical centers while HepB-alum was administered in the other 8 centers. Recipients of HepB-CpG or HepB-alum were followed through electronic health records for 13 months for occurrence of pre-specified new-onset immune-mediated diseases, HZ, and anaphylaxis identified using diagnosis codes. Incidence rates were compared using Poisson regression with inverse probability of treatment weighting when there was ≥80 % power to detect a relative risk (RR) of 5 for anaphylaxis and RR of 3 for other outcomes. Chart review to confirm new-onset diagnosis was conducted for outcomes with statistically significant elevated risk. ResultsThere were 31,183 HepB-CpG and 38,442 HepB-alum recipients (overall 49.0 % female, 48.5 % age ≥50 years, and 49.6 % Hispanic). Among immune-mediated events that occurred frequently enough for formal comparison, rates among HepB-CpG versus Hep-B-alum recipients were similar except for rheumatoid arthritis (RA) (adjusted RR 1.53 [95 % CI: 1.07, 2.18]). After chart confirmation of new-onset RA, the adjusted RR was 0.93 (0.34, 2.49). The adjusted RR for HZ was 1.06 (0.89, 1.27). Anaphylaxis occurred in 0 HepB-CpG and 2 HepB-alum recipients. ConclusionsThis large post-licensure study did not identify evidence of safety concerns for HepB-CpG compared to HepB-alum for immune-mediated diseases, HZ, or anaphylaxis.

JAK inhibition in the treatment of inflammatory rheumatic diseases.

The most common immune-mediated inflammatory rheumatic diseases, rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis and have reached significant advances in recent years with the introduction of biological therapies against cytokines and immune cells, but also against intracellular enzymes, specifically Janus kinases (JAKs). Intracellular JAK signalling is activated by binding of various cytokines or growth factors to the respective cellular receptors, allowing the activation of STAT (Signal Transducers and Activators of Transcription) transcription factors and ultimately the transcription of genes with important roles during the innate and adaptive immune response. Four Janus kinases have been described: JAK1, JAK2, JAK3 and tyrosine kinase-2 (TYK2). Four JAK inhibitors (tofacitinib, baricitinib, upadacitinib and filgotinib) are currently approved for the treatment of rheumatoid arthritis, and some for the treatment of psoriatic arthritis and axial spondyloarthritis. JAK inhibitors have varying selectivity against individual kinases. Some JAK inhibitors are being tested in other rarer systemic connective tissue diseases. The general advantages of JAK inhibitors are oral administration, rapid onset of action, and efficacy in monotherapy. The safety profile of JAK inhibitors compared with biologic therapy appears to be comparable, with a higher incidence of herpes zoster, and an increased incidence of major cardiovascular disease, thromboembolic complications, and cancer in at-risk patients is discussed. The aim of this paper will be to summarize the latest findings on JAK inhibitors in approved indications for the most common rheumatic diseases.

Top 100 Most-Cited Papers in Herpes Zoster from 2000 to 2022: A Bibliometric Study.

In recent years, the incidence of herpes zoster has risen steeply, the exact pathogenesis of the acute pain and the transformation into postherpetic neuralgia are still obscure, and the absence of effective management remains a major therapeutic challenge. The purpose of this study was to perform a qualitative and quantitative bibliometric analysis of the 100 most cited papers on herpes zoster. Related literature were retrieved from the Web of Science Core Collection. Excel and VOSviewer software were applied to quantitatively analyze, and construct the bibliometric network charts. The Top 100 most-cited papers published between 2000 and 2018 showed a fluctuating downward trend. The most studies were published in the year of 2000 (n = 12). The article entitled "A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults" from Oxman MN, was the most-cited publication. The United States was the most contributing country, followed by the United Kingdom, and Italy. Finland occupied the highest citations per publication (CPP). The University of Colorado topped the list of institutions with the most publications with 18 articles and also had the most citations (average citations: 281.78 per article). Myron J Levin from the University of Colorado School of Medicine is the most published and most cited researcher overall, whereas Duke University's John W Gnann tops the list in terms of average CPP. In terms of the quantity of T100 articles, researchers, and organizations, the US is the predominant country. The most T100 papers were published in the special journal Clinical Infectious Diseases. The most academic focus remain the remedies for postherpetic neuralgia and vaccine development for individualized groups.

Universal varicella vaccination in Denmark: Modeling public health impact, age-shift, and cost-effectiveness.

We modeled the long-term clinical and economic impact of two-dose universal varicella vaccination (UVV) strategies in Denmark using a dynamic transmission model. The cost-effectiveness of UVV was evaluated along with the impact on varicella (including age-shift) and herpes zoster burden. Six two-dose UVV strategies were compared to no vaccination, at either short (12/15 months) or medium (15/48 months) intervals. Monovalent vaccines (V-MSD or V-GSK) for the 1st dose, and either monovalent or quadrivalent vaccines (MMRV-MSD or MMRV-GSK) for the 2nd dose were considered. Compared to no vaccination, all two-dose UVV strategies reduced varicella cases by 94%-96%, hospitalizations by 93%-94%, and deaths by 91%-92% over 50 years; herpes zoster cases were also reduced by 9%. There was a decline in the total number of annual varicella cases in all age groups including adolescents and adults. All UVV strategies were cost-effective compared to no vaccination, with ICER values ranging from €18,228-€20,263/QALY (payer perspective) and €3,746-€5,937/QALY (societal perspective). The frontier analysis showed that a two-dose strategy with V-MSD (15 months) and MMRV-MSD (48 months) dominated all other strategies and was the most cost-effective. In conclusion, all modeled two-dose UVV strategies were projected to substantially reduce the clinical and economic burden of varicella disease in Denmark compared to the current no vaccination strategy, with declines in both varicella and zoster incidence for all age groups over a 50-year time horizon.

The Effect of CT-Guided Pulsed Radiofrequency Combined with Ozone Injection on Zoster-Associated Pain: A Retrospective Study.

Globally, the incidence of herpes zoster (HZ) is increasing, and the resulting zoster-associated pain (ZAP) severely affects the quality of life of patients. Therefore, active treatment of ZAP and prevention of postherpetic neuralgia (PHN) are very important for patients in the early stage of the disease. This retrospective observational study aimed to evaluate the effect of CT-guided pulsed radiofrequency (PRF) combined with ozone injection on zoster-associated pain. From 2018 to 2020, 84 patients with AHN (n=28), SHN (n=32), or PHN (n=24) underwent PRF combined with ozone injection treatment after pharmacologic and conservative therapies failed. The visual analogue scale (VAS), the Pittsburgh Sleep Quality Index (PSQI), and pregabalin consumption were recorded at baseline, post-PRF, and at 1, 3, 6, and 12 months after treatment. The number of remediations performed and adverse reactions were recorded, and treatment inefficiency was calculated using a VAS score greater than 3 as the criterion. The pooled results demonstrated statistically significant decreases in VAS scores, PSQI scores and consumption of pregabalin post-PRF and at 1, 3, 6, and 12 months follow-up (P<0.05). Compared with the PHN group, both the AHN and SHN groups showed clinical and statistical improvement in VAS scores and PSQI scores and in consumption of pregabalin (P< 0.05). At 1 year after the operation, the PHN group had a significantly greater number of remediation events and greater treatment inefficiency than the other two groups. No serious adverse events were observed during the procedure or during the follow-up period. CT-guided PRF combined with ozone injection is safe and effective for individuals with ZAP, and its short-term and long-term effects are significant. In a sense, early PRF combined with ozone injection is more effective.

Herpes Zoster: a case series with different manifestations

Background: The incidence of herpes zoster appears to correlate inversely with the host's ability to mount a cellular immune response. The disease is characterized clinically by an acute rash with herpetiform blisters on the skin and mucous membranes. This case series presented the different clinical presentations of herpes zoster infection in three patients with different underlying diseases in the ophthalmic, trigeminal, cervical, and thoracic dermatomes. Case Presentation: Three cases of herpes zoster were observed in this case series. The first case involved the ophthalmic division of the trigeminal nerve. The second case involved the cervical nerve, and the last case involved the thoracic nerve. All had undergone varicella infection in childhood and suffered from various states leading to immunosuppression. Tzanck smears were performed in all cases, which showed multinucleated giant cells. After treatment following the herpes zoster protocol, all cases healed without complications. Conclusion: Reactivation of the varicella-zoster virus may occur spontaneously or when host immunity is weakened. Increasing age, a physical trauma (including dental procedures), psychological stress, malignancy, and immunocompromised conditions, including transplant recipients, pregnancy, and HIV infection, are predisposing factors for varicella-zoster virus reactivation.

Incidence of Herpes Zoster in Patients With Rheumatoid Arthritis in the United States: A Retrospective Cohort Study.

To estimate the incidence of herpes zoster (HZ) in patients with rheumatoid arthritis (RA) compared with the general population in the USA. This retrospective, longitudinal cohort study used data from an administrative claims database containing both commercial and Medicare Advantage Part D data, with a data period from October 2015 to February 2020. Patients were aged ≥ 18 years and divided into 2 cohorts: patients with RA and patients without RA. Diagnosis and procedure codes were used to identify HZ cases and calculate incidence rates (IRs) of HZ in the 2 cohorts. Data were stratified by age group (ie, 18-49, 18-29, 30-39, 40-49, 50-64, and ≥ 65 yrs) and RA therapy type. IR ratios (IRRs), adjusted by cohort baseline characteristics, were estimated using generalized linear models to compare the incidence of HZ between cohorts. The overall IR of HZ was higher in the RA cohort (21.5 per 1000 person-years [PY]; N = 67,650) than in the non-RA cohort (7.6 per 1000 PY; N = 11,401,743). The highest IRs in both cohorts were observed in the age group of ≥ 65 yrs (23.4 and 11.4 per 1000 PY in the RA cohort and non-RA cohort, respectively). The overall adjusted IRR of HZ was 1.93 (95% CI 1.87-1.99, P < 0.001) for the RA cohort compared with the non-RA cohort. In the RA cohort, the highest IRs by medication class were observed in patients using corticosteroids and those using Janus kinase inhibitors. These results highlight the increased incidence of HZ in patients with RA.

Incidence of Herpes Zoster in Patients with Asthma Compared to Patients without Asthma: A Retrospective Database Study

Compared to the general population, patients with asthma may be at increased risk of herpes zoster (HZ). This study sought to estimate the incidence of HZ in patients with asthma and compared to patients without asthma.

Herpes zoster

Chickenpox, like herpes zoster, is caused by the same varicella-zoster virus, which belongs to the herpesvirus family. After chickenpox, the varicella-zoster virus can remain latent for life in the trigeminal ganglia and dorsal root ganglia. Reactivation of the virus occurs in immunodeficiency states against the background of malignant neoplasms, HIV infection, stress effects, and the use of immunosuppressive therapy. Internal organs may also be involved in the pathological process. Unlike chicken pox, the leading pathogenetic mechanism in herpes zoster is neurotropism. The incidence of herpes zoster is obser ved in persons who have had chick enpox.

P781 Treatment outcome of tofacitinib dose reduction to 5 mg BID vs remaining on 10 mg BID in patients with Ulcerative Colitis who were in stable remission on 10 mg BID: Updated 30-month data from the double-blind, randomised RIVETING study

Abstract Background Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. The long-term, Phase 3b/4 RIVETING study (NCT03281304) assessed the efficacy and safety of tofacitinib dose reduction from tofacitinib 10 mg twice daily (BID) maintenance therapy to 5 mg BID in patients (pts) in stable remission.1 We present a final analysis of the RIVETING study after ≥30 months of treatment. Methods RIVETING was a double-blind, randomised, parallel-group study with a 42-month (M) duration. Eligible pts had received tofacitinib 10 mg BID for ≥2 consecutive years in an open-label, long-term extension study (NCT01470612), had been in stable remission for ≥6 months and corticosteroid-free for ≥4 weeks prior to baseline. The primary efficacy endpoint was remission at M6 based on modified Mayo (mMayo) score (endoscopic and stool frequency subscores of ≤1 and rectal bleeding subscore of 0).1 RIVETING was terminated (primary objective met) when all pts had passed M30 (or discontinued); some pts had already completed all visits up to M42. Here, we assess efficacy at M30 and safety throughout. Results Overall, 140 pts were randomised (1:1) to tofacitinib 5 or 10 mg BID; 50.0% and 62.9% were in remission based on mMayo score at M30 in the 5 and 10 mg BID dose groups, respectively, with consistent findings observed for other secondary efficacy endpoints (Table 1). At M30, observed differences for mMayo remission between tofacitinib 10 and 5 mg BID were generally greater in the subgroup with a baseline endoscopic subscore of 1 vs 0 and in the subgroup with vs without prior tumour necrosis factor inhibitor (TNFi) failure (Table 1). The percentage of pts who experienced loss of remission by M30, as estimated from Kaplan-Meier curves, was numerically higher in the 5 vs the 10 mg BID dose group (28.1%; 95% confidence interval [CI], 17.68–39.49 vs 21.7%; 95% CI, 12.21–32.95, respectively). Table 2 shows adverse events of special interest, by dose group. One death occurred due to fatal coronavirus disease 2019 pneumonia (10 mg BID). Conclusion These long-term data showed that most pts in stable remission on tofacitinib 10 mg BID maintenance therapy maintained mMayo score remission through M30 after dose reduction to 5 mg BID. Dose group difference in remission at M30 was consistent with that at M6.1 Differences in remission between the tofacitinib 5 and 10 mg BID groups were greater in subgroups with an endoscopic subscore of 1 vs 0 and in subgroups with vs without prior TNFi failure. Overall, safety findings were consistent with tofacitinib’s known safety profile; incidence of serious infections and herpes zoster was numerically higher in the tofacitinib 10 vs 5 mg BID group. 1. Vermeire S et al. J Crohns Colitis 2021;15:1130-41.

P845 Increased incidence of herpes zoster in patients with Inflammatory Bowel Diseases in Europe

Abstract Background Immunocompromised (IC) patients, including those with autoimmune Inflammatory Bowel Diseases (IBD), are at increased risk for herpes zoster (HZ). HZ affects one in three adults aged ≥50 years, with complications of post-herpetic neuralgia (PHN) in around one in ten affected adults. PHN impacts patients’ health-related quality of life and is difficult to treat. Both HZ and PHN place a financial burden on healthcare systems. The objective was to systematically review the incidence of HZ in IC populations. Methods A systematic literature review was performed to identify observational studies reporting on the HZ incidence in a broad range of IC populations in the European Union/European Economic Area, Switzerland and United Kingdom (2002-2022). The results for IBD patients are reported here. Results Overall, 26 studies reported HZ incidence rates, with three reporting on IBD patients. In Valencia, Spain, using hospital and primary care data in adult patients (≥18 years), HZ incidence rates were higher in IBD patients versus non-IC patients, and increased with age (Table 1). In this study, IBD versus non-IC patients had significantly higher rates of HZ complications (7.67 [3.51-14.57] vs. 2.64 [2.42-2.86] per 100,000 person-years [PY]) and of HZ recurrence (2.48 [2.06-2.96] vs. 1.56 [1.53-1.59] per 100 PY), driven by high rates in patients ≥60 years.1 In England, data from the Clinical Practice Research Datalink matched IBD patients (≥18 years) to non-IC patients. HZ incidence was higher in IBD versus non-IC patients and increased with age (Table 1).2 From German claims data (2012) in over ten million adults (≥18 years), HZ incidence in patients with ulcerative colitis and Crohn’s disease were higher than in the non-IC population (Table 1).3 Table 1. HZ incidence rate (per 1,000 person-years) in IBD versus non-IC patients Conclusion Three large real-world studies confirmed significantly higher HZ incidence rates in IBD versus non-IC patients, with higher rates in older age groups. These findings support healthcare providers and guideline committees in reinforcing HZ prevention strategies for IBD patients. An adjuvanted recombinant HZ vaccine is the first approved for use in IC populations, and may help reduce the healthcare system and patient burden.

Association between Meteorological Factors and Outpatient Visits for Herpes Zoster in Hefei, China: A Time-Series Analysis.

This study sought to investigate the relationship between meteorological factors and outpatient visits for herpes zoster. In this time-series analysis, we used data from two major hospitals in Hefei, collected between 2015 and 2019, to evaluate the impact of meteorological factors on the risk of herpes zoster. After controlling for confounders, we adopted a distributed lag nonlinear model to probe the relationship between meteorological factors and outpatient visits for herpes zoster. The analysis was stratified according to age (<40 years, ≥40 years) and sex (male, female). A total of 43,547 cases of herpes zoster were reported, and compared with the median value, a high temperature and high relative humidity had a significant risk effect on the incidence of herpes zoster. The maximum harmful effect of high temperature on herpes zoster occurred on the lag0 (RR: 1.027, 95% CI: 1.002-1.053) and further declined over the following days. The cumulative effect increased with the extension of lag days, and the cumulative RR was the largest on the sixth day of lag (RR1.031, 95% CI: 1.006-1.056) when the relative humidity was 85.7% (77.0% as the reference). The stratified analysis results reveal that females and the elderly (≥40 years) were more susceptible to temperature and relative humidity. This study shows that high-temperatures may lead to herpes zoster, indicating that those infected with varicella zoster virus need to take measures over the course of several days when not exposed to the best appropriate temperature conditions.

Incidence and risk of herpes zoster in patients with ulcerative colitis and Crohn's disease in the USA.

Patients with inflammatory bowel disease (IBD) are at increased risk of herpes zoster (HZ). We evaluated the incidence of HZ in ulcerative colitis (UC) and Crohn's disease (CD) patients and compared this with HZ incidence in a non-IBD population. We conducted a retrospective cohort study (GSK study identifier: VEO-000043) of adults aged ≥18 years with UC and CD and without IBD who were identified from claims recorded in a US healthcare database between October 2015 and February 2020. Crude HZ incidence rates/1,000 person-years (PY) were calculated, and comparisons of HZ incidence rates between UC or CD and non-IBD cohorts were made using adjusted generalized linear models. The study population comprised a total of 29,928 UC, 25,959 CD, and 11,839,329 non-IBD patients. Crude overall HZ incidence rates were 13.64/1,000 PY (UC), 15.94/1,000 PY (CD), and 7.95/1,000 PY (non-IBD). UC and CD patients had increased HZ incidence rates, with adjusted incidence rate ratios of 1.35 (95% confidence interval [CI], 1.26-1.44) and 1.66 (95% CI, 1.56-1.77), respectively, compared with non-IBD patients. Stratified analysis indicated increased relative rates of HZ in progressively younger age strata in the UC and CD patients compared with non-IBD patients. HZ incidence rates were higher in UC and CD patients who had previously received thiopurines or methotrexate, TNF-inhibitors, or corticosteroids than in UC and CD patients who did not take those medicines. UC and CD patients had increased HZ incidence rates compared with patients without IBD, demonstrating the importance of HZ prevention in IBD patients.

Recent topics in the management of herpes zoster.

Herpes zoster is a disease caused by reactivation of the varicella-zoster virus that has been latently infecting the body and is more common among the elderly. In Japan, the incidence of herpes zoster has been increasing steadily and is expected to increase further in the future. In 2016, the varicella vaccine was expanded to include prevention of herpes zoster, and a new subunit vaccine was also launched in 2020. In recent years, anti-herpesvirus drugs with novel pharmacological effects have also been introduced, and the environment surrounding the treatment of herpes zoster is entering a new era.

115. Post-licensure Safety Study of New-onset Immune-mediated Diseases, Herpes Zoster, and Anaphylaxis in Adult Recipients of HepB-CPG Vaccine Versus HepB-alum Vaccine

Abstract Background HepB-CpG (Heplisav-B; Dynavax) is a licensed hepatitis B vaccine with a novel adjuvant that requires only 2 doses (0, 1 month) compared to a 3-dose (0, 1, 6 months) HepB-alum vaccine (Engerix-B; GlaxoSmithKline). Monitoring of safety outcomes following receipt of vaccines with novel adjuvants is important. Hence, as part of an FDA postmarketing commitment, we compared the incidence of new-onset immune-mediated diseases, herpes zoster (HZ), and anaphylaxis among recipients of HepB-CpG versus HepB-alum at Kaiser Permanente Southern California (KPSC). Methods This cohort study included adults not on dialysis who received ≥1 dose of a hepatitis B vaccine from 8/7/2018 to 10/31/2019, during which HepB-CpG was routinely administered in 7 of 15 KPSC medical centers while HepB-alum was administered at the other 8 medical centers. Recipients of HepB-CpG or HepB-alum were followed through electronic health records for 13 months after receipt of the first dose during the vaccine accrual period for occurrence of pre-specified new-onset immune-mediated diseases, HZ, and anaphylaxis identified using diagnosis codes. Incidence rates were compared using Poisson regression with inverse probability of treatment weighting when there was 80% power to detect a relative risk (RR) of 5 for anaphylaxis and a RR of 3 for all other outcomes Results There were 31,183 HepB-CpG and 38,442 HepB-alum recipients (overall 49.0% female, 48.5% ≥50 years of age, and 49.6% Hispanic). Among immune-mediated events that occurred frequently enough for formal comparison, rates among HepB-CpG versus Hep-B-alum recipients were similar except for rheumatoid arthritis (RA) (adjusted RR 1.53 [95% CI: 1.07, 2.18]). (Table 1) After adjudication of new-onset RA, the adjusted RR was 0.93 (0.34, 2.49). (Table 2) The adjusted RR for HZ was 1.06 (0.89, 1.27). Anaphylaxis occurred in 0 HepB-CpG and 2 HepB-alum recipients. Conclusion These data suggest no safety concerns for HepB-CpG compared to HepB-alum for select immune-mediated diseases, HZ, or anaphylaxis in this observational study of over 69,000 recipients of hepatitis B vaccines. Disclosures Bradley Ackerson, MD, Dynavax: Grant/Research Support|Glaxosmithkline: Grant/Research Support|Moderna: Grant/Research Support|Pfizer: Grant/Research Support|Seqirus: Grant/Research Support Lina S. Sy, MPH, Dynavax: Grant/Research Support|Glaxosmithkline: Grant/Research Support|Moderna: Grant/Research Support|Seqirus: Grant/Research Support Jeff Slezak, MS, ALK, Inc.: Grant/Research Support|Dynavax: Grant/Research Support|Novavax, Inc.: Grant/Research Support|Pfizer, Inc.: Grant/Research Support Lei Qian, PhD, Dynavax: Grant/Research Support|Glaxosmithkline: Grant/Research Support|Moderna: Grant/Research Support Kristi Reynolds, PhD, Amgen: Grant/Research Support|Dynavax: Grant/Research Support|Merck: Grant/Research Support|Novartis: Grant/Research Support Runxin Huang, MS, Dynavax: Grant/Research Support Zendi Solano, BS, Dynavax: Grant/Research Support|Gilead: Grant/Research Support|GlaxoSmithKline: Grant/Research Support William Towner, MD, Dynavax: Grant/Research Support|Gilead: Grant/Research Support|Merck: Grant/Research Support|Moderna: Grant/Research Support|Pfizer: Grant/Research Support|ViiV: Grant/Research Support Sijia Qiu, MS, Dynavax: Grant/Research Support|Moderna: Grant/Research Support Sarah Simmons, MPH, Dynavax: Grant/Research Support|Glaxo-Smith Kline: Grant/Research Support|Pfizer: Grant/Research Support Steven Jacobsen, MD, Dynavax: Grant/Research Support Katia J. Bruxvoort, PhD, MPH, Dynavax: Grant/Research Support|Gilead: Grant/Research Support|Glaxosmithkline: Grant/Research Support|Moderna: Grant/Research Support|Pfizer: Grant/Research Support|Seqirus: Grant/Research Support.

The impact of the COVID-19 pandemic on the incidence of herpes zoster

Abstract Background There have been several case reports of herpes zoster (HZ) following COVID-19 disease and vaccination. We conducted a non-systematic literature search to elucidate the global effects of the COVID-19 pandemic on the incidence of HZ. Methods The literature search was performed in October 2021 using PubMed and Embase. The search string was herpes zoster AND COVID-19. Publications were manually reviewed; case reports were removed. Results Three retrospective studies reported the risk of HZ following COVID-19 disease. One study (Bhavsar, 2021) used two US databases and found higher risk of HZ following COVID-19 disease (relative risk [RR]=1.15) and COVID-19 hospitalisation (RR = 1.21), respectively. A strong association between HZ and COVID-19 disease (RR = 5.27) was also reported in a study of the University of Florida patient registry (Katz, 2021). The third study (Barda, 2021) reported no association between COVID-19 disease and risk of HZ (RR = 0.82). In two of the three observational studies in Israel (Furer, 2021 and Barda, 2021), the incidence of HZ was increased following COVID-19 vaccination. The third study (Shasha, 2021) found no association (RR = 1.07). Other studies included a report in Brazil (Maia, 2021) that demonstrated a 35% increase in HZ diagnoses during the pandemic versus pre-pandemic and a published model (La, 2021) that estimated the declining uptake of recombinant zoster vaccine in the US may result in 63,117 avoidable HZ cases in those who remain unvaccinated in 2021. Conclusions Emerging data suggest that the COVID-19 pandemic may have increased the risk of HZ and negatively impacted HZ vaccine uptake. Therefore, there is an important need to increase awareness of HZ and HZ vaccination during the pandemic. Key messages • There is a need to increase awareness of HZ and HZ vaccination during the COVID-19 era. • Further studies are needed to fully understand the impact of COVID-19 on the risk of HZ.

The Impact of Universal Varicella Vaccination on Herpes Zoster Incidence in the United States: Comparison of Birth Cohorts Preceding and Following Varicella Vaccination Program Launch.

When the US varicella vaccination program was introduced in 1995, its impacts on the epidemiology of herpes zoster (HZ) were not precisely known. We used a large claims database to examine HZ incidence in the US during 1998-2019 among persons aged ≥30 years (the prevaccine cohort, born before 1990), and aged 1-29 years (includes the postvaccine cohort, born since 1990). We defined incident HZ as the first instance of an outpatient or emergency department (ED) claim with an HZ diagnostic code. Additionally, we examined the proportion of HZ visits among all ED visits as a complementary method to assess for healthcare-seeking artifacts in the findings. In persons aged ≥30 years (prevaccine cohort), we observed age-specific increases in HZ incidence during the earlier study years, with decelerations in later years, starting in 2007 with oldest age groups. Similar patterns were seen when we examined HZ visits as a proportion of all ED visits. For persons aged 1-29 years, age-specific HZ incidence increased early in the study period for the oldest age groups who were born prevaccine, but later declined in a stepwise pattern once each age group was comprised of persons born in the postvaccine period. Our results, corroborated with previously published studies, do not support prior modeling predictions that the varicella vaccination program would increase HZ incidence among adult cohorts who previously experienced varicella. Our findings also suggest that continued declines in age-specific HZ incidence as varicella-vaccinated cohorts age are likely.