Recombinant Zoster Vaccine Research Articles

Immunogenicity and Safety of the Recombinant Adjuvanted Herpes Zoster Vaccine in Patients with Chronic Lymphocytic Leukemia and Multiple Myeloma

Background/objectives: Patients with chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) are susceptible to viral infections, including varicella-zoster virus (VZV) reactivation due to both disease-related and treatment-induced immunosuppression. The recombinant adjuvanted herpes zoster vaccine (RZV) has shown high efficacy in immunocompetent adults, but immunogenicity data in CLL and MM patients are limited. This study evaluates the immunogenicity and safety of RZV in this population. Methods: Patients with CLL and MM vaccinated with RZV (administered in two doses at least one month apart) were included in the study. Pre- and post-vaccination anti-VZV IgM and IgG antibody levels were measured to assess immunogenicity, and adverse events (AEs) were captured for safety evaluation. Results: Seventy-eight patients received both vaccine doses, and 71 had post-vaccination samples. Most of the patients were IgM seronegative and IgG seropositive before vaccination. Pre-vaccination IgG levels were higher in CLL patients compared to MM patients (p = 0.001), while post-vaccination IgG levels significantly increased in both CLL (p < 0.0001) and MM (p < 0.0001) patients. In actively treated CLL patients, pre-vaccination IgG levels were significantly lower than in not actively treated patients (p = 0.002). Post-vaccination IgG levels were lower in MM patients receiving antiviral prophylaxis concurrently with the vaccination (p = 0.013). AEs were reported in 49.4% of patients after the first dose and 48.7% after the second dose, mostly mild (local or low-grade systemic). One case of immune thrombocytopenia was noted. Conclusions: RZV demonstrated strong immunogenicity and acceptable safety in CLL and MM patients, significantly boosting IgG levels, even in actively treated or heavily pretreated patients.

Case Report: Emergence of de novo Donor-Specific HLA antibodies post Pneumococcal & Varicella Zoster Vaccinations in Waitlisted Renal Transplant Candidate

Abstract Introduction/Objective In renal transplant waitlisted patients, vaccination series remains to be the standard of care for infection prevention. There is a need to investigate if any of these vaccines or their adjuvant components can induce de novo donor-specific antibodies (dnDSA) against human leukocyte antigens (HLA). These novel anti-HLA antibodies in renal transplant waitlisted patients can result in a positive flow cell crossmatch (FCXM) associated with an increased risk of renal transplant rejection. Methods/Case Report We present a 59-year-old renal transplant waitlisted patient who has had multiple negative T- cell and B-cell FCXM with no detection of dnDSA at baseline. We detected de-novo anti-HLA antibodies after he received pneumococcal conjugate (Pneum-C-13) and recombinant zoster vaccine (RZV). After vaccination, FCXM was positive for both T-cells and B-cells. HLA class I antibodies (A1, 23, 24, 80; B44, 45, 76) showed a panel reactive antibody (PRA) of 51%. Epitope analysis highlighted 166DG and 166ES as shared epitopes responsible for the entire specificity. The A1 dn-DSA had a mean fluorescence intensity (MFI) of 1800 and with shared A80 epitope MFI was 15,000 contributing to the strong positivity observed in T-cell and B-cell FCXM. New onset A1, and B44 DSA predicted high risk for transplant rejection with his sibling. His planned live donor renal transplant was halted and had to instead enter the kidney-paired donor program wherein he received his transplantation after 16 months. Results (if a Case Study enter NA) NA Conclusion Allosensitization risk secondary to RZV or Pneum-C-13 vaccines or their adjuvant components in renal transplant waitlisted patients must be considered as a potential risk for transplant rejection. Future studies can utilize monitoring of HLA-specific memory B-cells to provide crucial insights into the primary mechanism of action of dn-DSA anti-HLA antibody formation and suggest interventions to mitigate this memory B-cell activation.

Prolonged Neurological and Musculoskeletal Symptoms Following Shingrix Vaccination

Background: The recombinant zoster vaccine (Shingrix) helps prevent shingles and its complications in adults 50 and older. While minor side effects are common, severe adverse reactions are thought to be rare, and long-term side effects are not well documented. Case Presentation: A 50-year-old woman with Crohn’s disease developed joint pain, effusion, and neurological symptoms such as numbness and tingling shortly after receiving the first dose of the recombinant zoster vaccine. Symptoms waxed and waned but persisted for over a year despite anti-inflammatories and specialist referrals. Diagnostic imaging and labs were unrevealing. Conclusions: This case of prolonged somatic and neurological symptoms associated temporally with Recombinant zoster vaccine administration reinforces the critical need for thorough pharmacovigilance and investigation of possible long-term adverse vaccine reactions. Provider documentation and reporting of individual experiences can help improve the detection of rare vaccine-related risks, elucidate potential risk factors, and refine safety screening. Diligent monitoring and research into longitudinal vaccine outcomes remain paramount, especially following recent emergency authorizations.

Evaluation of the Recombinant Zoster Vaccine Campaign Targeting Healthcare Professionals for Shingles Prevention Awareness in India

Evaluation of the Recombinant Zoster Vaccine Campaign Targeting Healthcare Professionals for Shingles Prevention Awareness in India

Safety of Simultaneous Vaccination With Adjuvanted Zoster Vaccine and Adjuvanted Influenza Vaccine

Quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) and adjuvanted recombinant zoster vaccine (RZV) contain novel adjuvants. Data are limited on the comparative safety, reactogenicity, and health-related quality of life (HRQOL) effects of the simultaneous administration of these vaccines. To compare the safety and reactogenicity after simultaneous doses of RZV and aIIV4 administration (opposite arms) with simultaneous doses of RZV with quadrivalent high-dose inactivated influenza vaccine [HD-IIV4]). This randomized blinded clinical trial was conducted during the 2021-2022 and 2022-2023 influenza seasons at 2 centers in the US among community-dwelling adults aged 65 years or older. Analysis was performed on an intention-to-treat basis. Simultaneous intramuscular administration of RZV dose 1 and aIIV4 or HD-IIV4 in opposite arms after age stratification (65-69 and ≥70 years) and randomization. The primary outcome was the proportions of participants with 1 or more severe solicited reactions during days 1 to 8, using a noninferiority test (10% noninferiority margin). Additional measures included serious adverse events and adverse events of clinical interest during days 1 to 43 of the study period. A total of 267 adults (median age, 71 years [range, 65-92 years]; 137 men [51.3%]) were randomized; 130 received simultaneous RZV and aIIV4, and 137 received simultaneous RZV and HD-IIV4. The proportion of patients reporting 1 or more severe reactions after simultaneous administration of RZV and aIIV4 (15 of 115 [11.5%]) was noninferior compared with simultaneous RZV and HD-IIV4 (17 of 119 [12.5%]) (absolute difference, -1.0% [95% CI, -8.9% to 7.1%]). There were no significant differences in the number of serious adverse events or adverse events of clinical interest between the groups. In this clinical trial of simultaneous doses of RZV and aIIV4 compared with simultaneous doses of RZV and HD-IIV4, overall safety findings were similar between groups. From a safety standpoint, this study supports the simultaneous administration of RZV and aIIV4 among older adults. ClinicalTrials.gov Identifier: NCT05007041.

Lipo-pam™ adjuvanted herpes zoster vaccine induces potent gE-specific cellular and humoral immune responses

Herpes zoster (HZ), also known as shingles, is caused by the reactivation of latent varicella-zoster virus (VZV). Decreased VZV-specific T-cell immune responses significantly contribute to the development of HZ. Shingrix is a recombinant zoster vaccine that is currently used to prevent HZ. However, Shingrix has high reactogenicity and pain at the injection site due to QS21, one of the adjuvant components. In this study, we developed a new herpes zoster vaccine formulation called CVI-VZV-001, containing gE protein and a novel liposome-based adjuvant Lipo-pam™, which consists of two TLR agonists. We evaluated the immunogenicity of CVI-VZV-001 in mouse and rabbit models. CVI-VZV-001 elicited robust gE-specific T-cell immune responses and gE-specific antibody production. Specifically, CVI-VZV-001 induced polyfunctional CD4+ T cell populations that secrete multiple cytokines. Furthermore, CVI-VZV-001 sustained the gE-specific immune responses for up to six months after immunization. To ensure CVI-VZV-001’s safety for further development, we conducted a good laboratory practice (GLP) toxicity test, which confirmed that CVI-VZV-001 is safe for use. At present, CVI-VZV-001 is undergoing phase I clinical trials. This study suggests that CVI-VZV-001 can be a potent candidate for the HZ vaccine with high immunogenicity and safety.

Practices, Attitudes, and Knowledge Regarding Recombinant Zoster Vaccine Among Family Medicine Residents in Riyadh, Saudi Arabia.

Background The aim of the research is to determine the existing knowledge, perceived practices, and attitudes towardthe recombinant Zoster vaccine among family medicine residents (FMR) included in the medical profession. The present study aims to narrow down the identified gap in knowledge and develop vaccinations that will assist the targeted deme to eradicate zoster and the aftermaths that accompany it. Methods This research utilizes a descriptive cross-sectional survey design to assess the knowledge, practices, and attitudes of FMRtowardthe zoster vaccine in Riyadh, Saudi Arabia. By quantifying data at a specific point in time, this design allows for a detailed examination of the current status across various levels of residency programs. Participants from different institutions are interviewed simultaneously, enabling a thorough study of the targeted population group. The study includes 154 FMRfrom three different levels (R1, R2, R3) enrolled in residency programs at various institutions in Riyadh, Saudi Arabia. These participants were selected from a group of individuals invited to share their prior knowledge, habits, and beliefs regarding the recombinant Zoster vaccine. The study offers detailed statistical insights into demographics, vaccination attitudes, and knowledge among healthcare professionals. Key findings highlight diverse recommendations for different adult groups, the prevalence of vaccine availability, and the main sources of immunization information. Results The study found diverse recommendations for vaccination among different adult groups, with mean recommendations ranging from 2.50 to 2.94. Nearly all respondents (96.8%) reported having the vaccine available at their place of practice. However, knowledge gaps were evident, particularly concerning vaccination timing and specific requirements, highlighting the need for targeted education and clearer guidelines in vaccination practices among healthcare providers. Conclusion The study highlights the nuanced vaccination recommendations among healthcare professionals, particularly for different adult populations, and the availability of varicella-zoster virus (VZV) vaccines. The reliance on diverse information sources underscores the need for targeted educational efforts to ensure accurate and consistent immunization practices across healthcare settings. Addressing uncertainties and promoting informed decision-making can enhance vaccination uptake and patient care outcomes in clinical practice.

Herpes Zoster Awareness: A pilot centre analysis

Herpes zoster (HZ), or shingles, is caused by the reactivation of the varicella-zoster virus (VZV), which typically occurs years after a primary VZV infection (chickenpox). HZ is characterized by a painful, unilateral vesicular rash that usually affects a single dermatome, with common sites including thoracic, lumbar, cervical, and trigeminal regions. While HZ typically lasts 2-4 weeks, it can be particularly severe in elderly and immunocompromised individuals, leading to complications such as postherpetic neuralgia (PHN), cranial nerve palsy, and visual deficits. The incidence of HZ increases with age, and early antiviral treatment with acyclovir can reduce the severity of the acute phase and prevent serious eye complications in ophthalmic HZ cases. With an aging population, the prevalence of HZ is expected to rise, highlighting the need for effective vaccination strategies. Two types of vaccines are available: a live attenuated zoster vaccine (LZV) and a recombinant zoster vaccine (RZV), with the latter showing higher efficacy in preventing HZ. Despite this, awareness of HZ and its vaccine remains low. A survey conducted in Izmir, Turkey, revealed that while 59.2% of respondents were aware of HZ, only 18.3% knew about the vaccine. The study underscores the need for increased public health efforts to raise awareness and promote vaccination, especially among high-risk populations such as the elderly and immunocompromised individuals.

What is Different about Recombinant Herpes Zoster Vaccine?

Herpes zoster (HZ) affects about one in three persons in their life time. Compared with the general population, older adults with immune senescence and individuals who are immunocompromised therapy are at increased risk for HZ, and its debilitating complications. To prevent HZ, two HZ vaccines, zoster vaccine live (ZVL) and recombinant zoster vaccine (RZV) are available. RZV is The Korean Society of Infectious Diseases revised guidelines for HZ vaccine in 2023, and recommended to vaccinate with RZV for adults ≥ aged 50 years and for severely immunocompromised adults aged ≥ 18 years. RZV is more effective for prevention of HZ than ZVL. RZV is nonreplicating and is thus safe in immunocompromised patients. RZV has clinically acceptable safety profile. This review will help clinicians update knowledge about RZV and identify eligible subjects who may benefit from HZ vaccinations.

Herpes Zoster and Post-Herpetic Neuralgia-Diagnosis, Treatment, and Vaccination Strategies.

Herpes zoster is caused by the reactivation of latent varicella infection within the sensory ganglia, caused by the varicella-zoster virus (VZV). The disease is classically characterized by a painful unilateral vesicular eruption. Complications of the disease include herpes zoster ophthalmicus, Ramsay Hunt syndrome, acute retinal necrosis, and post-herpetic neuralgia. In this paper, we discuss the epidemiology, pathogenesis, clinical features, diagnosis, management, and vaccination strategies of herpes zoster and post-herpetic neuralgia. This paper was developed with input from specialists from Singapore's public sectors-dermatologists, family physicians, and infectious diseases specialists. The diagnosis of herpes zoster is clinical and can be aided with laboratory investigations. Early initiation of antivirals, within 72 h of onset, can reduce the severity and duration of the condition and decrease the intensity of pain. In patients with a high risk of post-herpetic neuralgia, early initiation of anticonvulsants or tricyclic antidepressants can be considered. Herpes zoster is highly preventable, with the advent of the recombinant zoster vaccine (RZV) providing an overall vaccine efficacy of 97.2%. Procedures such as epidural blocks and subcutaneous or intracutaneous injections of local anesthetics and steroids can be considered for patients with a high risk of post-herpetic neuralgia to reduce its incidence. This article serves as a guideline for clinicians in the diagnosis, investigations, management, and prevention of herpes zoster. With the majority of adults in Singapore currently at risk of developing herpes zoster due to varicella immunization being only introduced in 2020, it is important for clinicians to recognize and manage herpes zoster appropriately.

Risk of incident gout following exposure to recombinant zoster vaccine in US adults aged ≥65 years

ObjectiveAssess the risk of incident gout following exposure to recombinant zoster vaccine (RZV). MethodsThis case-only, self-controlled risk interval study included a cohort of US fee-for-service Medicare (Part A, B, and D) beneficiaries aged ≥65 years. The exposure was receipt of at least one dose of the two-dose RZV regimen in 2018 or 2019. The risk and control windows were days 1–30 and days 31–60, respectively, following vaccination. Incident gout was defined as the first episode of gout during the risk or control window, with no evidence of gout in the last 365 days. We estimated the relative risk (RR) and 95 % confidence interval (CI) of incident gout in the risk window relative to the control window, using conditional Poisson regression models. Sensitivity analyses included a dose-compliant subanalysis of individuals who received dose 2 60–183 days after dose 1; dose-specific analysis; seasonality adjustment; and COVID-19 adjustment for potential detection bias due to the pandemic. ResultsThe 1290 RZV-exposed individuals with incident gout were primarily White (86.98 %), male (61.16 %), and aged 70–79 years (55.82 %). The RR of incident gout was 1.00 (95 % CI 0.90, 1.12). In the dose-compliant sensitivity analysis (n = 959 cases of incident gout), the RR of incident gout was 0.99 (95 % CI 0.87, 1.13). The findings were unchanged in the dose-specific, seasonality, and COVID-19 sensitivity analyses. ConclusionThe findings suggest that RZV is not significantly associated with an increased risk of incident gout in the Medicare population aged ≥65 years.

Comparison of the Immunogenicity of the LZ901 Vaccine and HZ/su Vaccine in a Mouse Model.

Herpes zoster (HZ) is an infectious disease caused by the reactivation of varicella zoster virus (VZV), with 68% of cases occurring in adults over 50 years of age. HZ/su (Shingrix®) was approved by the Food and Drug Administration in 2017 for the prevention of HZ in individuals ≥ 50 years of age and showed very good protection from HZ. However, due to the use of the adjuvant AS01B, adverse reactions caused by Shingrix are a concern. Aluminum hydroxide is the most commonly used adjuvant and is widely used in a variety of vaccines. We developed a recombinant zoster vaccine (code: LZ901) consisting of a tetramer of VZV glycoprotein E (gE) and a human Fc fusion protein expressed in CHO cells, an immune complex-like molecule that can be adsorbed with an aluminum hydroxide adjuvant. We compared the immunogenicity of LZ901 with that of HZ/su in BALB/c mice. The results showed that LZ901 induced levels of gE-specific IgG antibodies comparable to those induced by HZ/su, and the results of FAMA titers further demonstrated their similar neutralizing antibody abilities. Most importantly, LZ901 induced higher levels of cell-mediated immunity (CMI) (which plays a decisive role in the efficacy of zoster vaccines) than HZ/su in BALB/c mice. The numbers of cytokine-producing T cells in LZ901-vaccinated mice were significantly greater than those in v-vaccinated mice, and the proportions of CD4+ and CD8+ T cells producing at least two types of cytokines in LZ901-vaccinated mice were significantly greater than those in HZ/su-vaccinated mice.

Trained Immunity Generated by the Recombinant Zoster Vaccine.

Trained immunity may play a role in vaccine-induced protection against infections. We showed that the highly efficacious recombinant VZV-gE zoster vaccine (RZV) generated trained immunity in monocytes, natural killer (NK) cells, and dendritic cells (DCs) and that the less efficacious live zoster vaccine did not. RZV stimulated ex vivo gE-specific monocyte, DC and NK cell responses that did not correlate with CD4 + T-cell responses. These responses were also elicited in purified monocyte and NK cell cocultures stimulated with VZV-gE and persisted above prevaccination levels for ≥ 4 years post-RZV administration. RZV administration also increased ex vivo heterologous monocyte and NK cell responses to herpes simplex and cytomegalovirus antigens. ATAC-seq analysis and ex vivo TGFβ1 supplementation and inhibition experiments demonstrated that decreased tgfβ1 transcription resulting from RZV-induced chromatin modifications may explain the development of monocyte trained immunity. The role of RZV-trained immunity in protection against herpes zoster and other infections should be further studied.

Retraction notice to Cost-effectiveness of the Recombinant Zoster Vaccine among People Living with Human Immunodeficiency Virus in Japan: [VHRI Volume 44, November 2024, 101025]

ObjectivesPeople living with HIV (PLWHIV) are susceptible to opportunistic infections including herpes zoster (HZ) and postherpetic neuralgia (PHN). The recombinant zoster vaccine (RZV) (Shingrix) is available in some countries. However, the cost-effectiveness for PLWHIV remains unknown. This study aimed to analyze the cost-effectiveness of RZV for PLWHIV ≥50 years old. MethodsA Markov model was developed to compare the cost-effectiveness of the 2-dose RZV immunization program with no RZV immunization for PLWHIV aged ≥50 years. We built the model with a yearly cycle over a 30-year period and 6 health conditions: HZ free, HZ, PHN, HZ/PHN recovery, HZ recurrence, and death. The parameters in the model were based on previous studies and a nationwide administrative claims database in Japan. The incremental cost-effectiveness ratio (ICER), expressed as Japanese yen (JPY) per the quality-adjusted life-years (QALYs), was estimated from a societal perspective. We conducted a one-way deterministic sensitivity analysis, probabilistic sensitivity analysis with Monte Carlo simulations of 10 000 samples, and scenario analyses. ResultsThe ICER of the 2-dose RZV immunization program over no RZV immunization was 78 777 774 JPY (approximately 600 000 US dollars)/QALY. The one-way deterministic sensitivity analysis showed that HZ-related utility was the most significant for ICER. All estimates in the probabilistic sensitivity analysis were located above the willingness-to-pay threshold of 5 million JPY/QALY. ConclusionsOur study revealed that no RZV immunization was more cost-effective than the 2-dose RZV immunization program for PLWHIV aged ≥50 years. This may be useful in evidence-based policy making.

Prior herpes zoster occurrence and high-dose corticosteroids increase herpes zoster risk in rheumatoid arthritis patients receiving janus kinase inhibitors in a retrospective and observational study.

Herpes zoster (HZ) risk is increased in rheumatoid arthritis (RA) patients receiving Janus kinase inhibitors (JAKi) therapy. Identifying and evaluating the risk factors of HZ development in patients receiving JAKi therapy would be clinically helpful. We investigated HZ's incidence rates (IR), identified the risk factors, and further assessed their influence on HZ development in RA patients undergoing JAKi therapy. We retrospectively evaluated 249 RA patients who received JAKi therapy between 2015 and 2023. Data regarding clinical characteristics, HZ reactivation, HZ vaccination status, and concomitant medication use were collected. Among 249 JAKi-treated patients, 44 developed new-onset HZ (tofacitinib, 28/142; baricitinib, 6/35; upadacitinib,10/72), with an IR of 5.11/100patient-years. Multivariate analysis revealed significant predictors of HZ development: a long JAKi exposure period, prior HZ or COVID-19 history, and concomitant high-dose corticosteroids use. The interval between JAKi initiation and HZ development was significantly shorter in patients with prior HZ history than in those without (median, 6.5months versus 33.5months, p < 0.001), suggesting "biphasic" emergence of HZ. Only one patient who had experienced an HZ episode while receiving JAKi developed recurrent HZ. None of the seventeen patients immunized with the non-live recombinant zoster vaccine developed HZ. Our JAKi-treated patients had elevated HZ risks, a class effect across different JAKi. A long exposure period, prior history of HZ or COVID-19, and concomitant high-dose corticosteroid treatment may further increase the risk. The emergence of HZ shows a biphasic pattern: early HZ development in patients with prior HZ and late development in those without. Key Points • An increased risk of HZ was observed in Taiwanese RA patients treated with JAKi, presenting as a class effect. • Patients with a long JAKi exposure period, prior history of HZ or COVID-19, and concomitant use of high-dose corticosteroids were at high risk of HZ while receiving JAKi therapy. • The interval between JAKi initiation and HZ occurrence was shorter in patients with prior HZ than in those without, showing "biphasic" emergence.

Preventing herpes zoster in immunocompromised patients: Current concepts.

Herpes zoster (HZ) incidence is much higher in immunocompromised individuals than in immunocompetent individuals. HZ also occurs at a younger age and is often more severe in immunocompromised persons. Preventive strategies center around the recombinant zoster vaccine (RZV), which is approved for immunocompromised adults age 19 and older. Identifying those at greatest risk is critical. For those considering vaccination, evidence gaps regarding vaccine efficacy, toxicity, length of protection, and potential effects on underlying conditions may complicate shared and informed decision-making. Recent data have filled some of these gaps, with several societies issuing recommendations regarding vaccination. Remaining gaps are currently addressed by expert opinion.

The public health impact of recombinant herpes zoster vaccination in adults over 50 years in Spain

ABSTRACT The recombinant zoster vaccine (RZV) is included in the Spanish National Immunisation Programme for adults 65 years of age (years), with a potential progressive catch-up program for adults 66–80 years, starting with 80 years. However, the risk of herpes zoster (HZ) increases significantly from 50 years. We estimated the public health impact (PHI) of vaccinating adults ≥50 years in Spain versus no vaccination, using a Markov model adapted to the Spanish setting. The model simulated a hypothetical ≥50 years cohort over a lifetime, with inputs from Spanish publications, databases, or publications from other countries where Spanish data were unavailable. Base case inputs included 67.7% RZV coverage and 61.1% second dose compliance. Outputs included clinical outcomes avoided, healthcare resource use avoided, and number-needed-to-vaccinate (NNV) to prevent one HZ case. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were also conducted. The model estimated that, compared with no vaccination, vaccinating adults ≥50 years in Spain (N = 19,850,213) with RZV could prevent 1,533,353 HZ cases, 261,610 postherpetic neuralgia episodes, 274,159 other complications, and 138 deaths through the cohorts’ remaining lifetime, mostly in the 50–59 years cohort. Furthermore, 3,500,492 primary care visits and 71,156 hospitalizations could be avoided, with NNV = 9 to prevent one HZ case. DSA predicted NNV = 7 to prevent one HZ case when second dose compliance was increased to 100%. PSA demonstrated ≥200,000 and ≥1,400,000 cases could be prevented in 86.9% and 18.4% of simulations, respectively. Starting RZV from 50 years could therefore prevent a substantial number of HZ cases and complications. Increasing RZV coverage and second dose compliance could further alleviate PHI of HZ.

Exploring the Link between Varicella-Zoster Virus, Autoimmune Diseases, and the Role of Recombinant Zoster Vaccine.

The varicella-zoster virus (VZV) is a human neurotropic herpes virus responsible for varicella and herpes zoster (HZ). Following primary infection in childhood, VZV manifests as varicella (chickenpox) and enters a period of latency within the dorsal root ganglion. A compromised cellular immune response due to aging or immunosuppression triggers viral reactivation and the development of HZ (shingles). Patients with autoimmune diseases have a higher risk of developing HZ owing to the immunodeficiency associated with the disease itself and/or the use of immunosuppressive agents. The introduction of new immunosuppressive agents with unique mechanisms has expanded the treatment options for autoimmune diseases but has also increased the risk of HZ. Specifically, Janus kinase (JAK) inhibitors and anifrolumab have raised concerns regarding HZ. Despite treatment advances, a substantial number of patients suffer from complications such as postherpetic neuralgia for prolonged periods. The adjuvanted recombinant zoster vaccine (RZV) is considered safe and effective even in immunocompromised patients. The widespread adoption of RZV may reduce the health and socioeconomic burdens of HZ patients. This review covers the link between VZV and autoimmune diseases, assesses the risk of HZ associated with immunosuppressant use, and discusses the benefits and risks of using RZV in patients with autoimmune diseases.

Efficacy, reactogenicity, and safety of the adjuvanted recombinant zoster vaccine for the prevention of herpes zoster in Chinese adults ≥ 50 years: A randomized, placebo-controlled trial

ABSTRACT Phase III multi-country studies (ZOE-50/70) demonstrated that the adjuvanted recombinant zoster vaccine (RZV) was well tolerated and prevented herpes zoster (HZ) in healthy ≥ 50-year-olds, with a vaccine efficacy (VE) > 90% across age groups. These pivotal trials did not enroll participants from mainland China where RZV is licensed, therefore similar clinical data are missing for this population. In this phase IV observer-blind study (NCT04869982) conducted between 2021 and 2023 in China, immunocompetent and medically stable ≥ 50-year-olds were randomized 1:1 to receive two RZV or placebo doses, 2 months apart. This study assessed the VE (overall, as confirmatory objective, and descriptively by age category [50–69-year-olds/≥ 70-year-olds]), reactogenicity, and safety of RZV in this Chinese population. Of the 6138 enrolled participants, 99.2% completed the study. During a mean follow-up period of 15.2 (±1.1) months, 31 HZ episodes were confirmed (RZV = 0; placebo = 31) for an incidence rate of 0.0 vs 8.2 per 1000 person-years and an overall VE of 100% (89.82–100). The descriptive VE was 100% (85.29–100) for 50–69-year-olds and 100% (60.90–100) for ≥ 70-year-olds. Solicited adverse events (AEs) were more frequent in the RZV vs the placebo group (median duration: 1–3 days for both groups). Pain and fatigue were the most frequent local and general AEs (RZV: 72.1% and 43.4%; placebo: 9.2% and 5.3%). The frequencies of unsolicited AEs, serious AEs, potential immune-mediated diseases, and deaths were similar between both groups. RZV is well tolerated and efficacious in preventing HZ in Chinese ≥ 50-year-olds, consistent with efficacy studies including worldwide populations with similar age and medical characteristics.

Knowledge, Attitudes, and Practices Regarding Herpes Zoster Vaccination Among Specialists.

Recombinant zoster vaccine has been recommended by the US Advisory Committee on Immunization Practices (ACIP) for the prevention of herpes zoster (HZ) in immunocompetent adults aged at least 50 years since 2018. In January 2022, this was extended to immunodeficient/immunosuppressed adults aged at least 19 years. Key study objectives were to assess specialists' knowledge of the ACIP HZ vaccination recommendations, their attitudes toward HZ vaccination, and HZ vaccination practices/barriers. This cross-sectional, web-based survey (conducted in March 2022) included US dermatologists, gastroenterologists, infectious disease specialists, oncologists, and rheumatologists who treat patients with psoriasis, inflammatory bowel disease, human immunodeficiency syndrome, solid tumors/hematological malignancies, and rheumatoid arthritis, respectively. Although most of the 613 specialists correctly identified the ACIP HZ vaccination recommendations for adults aged at least 50 years (84%) and immunodeficient/immunosuppressed adults aged at least 19 years (67%), only 29% knew that recombinant zoster vaccine is recommended for individuals who have previously received zoster vaccine live, and only 18% knew all current ACIP recommendations. For patients with the diseases listed, 84% of specialists thought that HZ is a serious risk, 75% that HZ vaccination is extremely/very important, and 69% were extremely/very likely to recommend HZ vaccination. Only 36% administer vaccines themselves, mainly because patients receive vaccinations from others. Barriers to vaccination included more urgent/acute issues, insufficient time, and lack of patient motivation/willingness. Full knowledge of the ACIP HZ vaccination recommendations among the surveyed specialists was low. There may be a need to educate specialists to improve adherence to these recommendations. [Figure: see text].