Persistence of Immune Response to an Adjuvanted Varicella-Zoster Virus Subunit Candidate Vaccine for up to Year 9 in Older Adults

Pauksens, Karlis; Volpe, Stéphanie; Schwarz, Tino F.; Smetana, Jan; Toursarkissian, Nicole; Rombo, Lars; Ravault, Stéphanie; David, Marie-Pierre; Bastidas, Adriana; Oostvogels, Lidia

doi:10.1093/ofid/ofx163.1039

Cited by 8 publications

(10 citation statements)

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“…The number needed to vaccinate (NNV) was higher for the live attenuated zoster vaccine than for the recombinant subunit zoster vaccine for all herpes zoster-related events at all ages. For example, in persons exactly 65 years old, for herpes zoster, median NNV was 21 (90% uncertainty interval [UI] 13-31) versus 8 (90% UI [6][7][8][9][10][11][12][13][14][15][16][17][18], and for postherpetic neur algia, NNV was 64 (90% UI 33-93) versus 31 (90% UI . For the recombinant vaccine, the median cost-effectiveness ratios varied between cost-saving and $25 881 per QALY gained for adults aged 50 years or older.…”

Section: Resultsmentioning

confidence: 99%

Effectiveness and cost-effectiveness of vaccination against herpes zoster in Canada: a modelling study

Drolet

Zhou

Sauvageau

et al. 2019

CMAJ

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H erpes zoster, characterized by dermatomal pain and rash, 1,2 affects about 1 of every 3 persons during their lifetime. 3-5 The most common complication is longlasting debilitating pain, known as postherpetic neuralgia, which occurs in about 8% to 27% of individuals with herpes zoster. 6-10 Given that postherpetic neuralgia has a substantial negative impact on health-related quality of life 11 and that therapeutic options are only partially effective, 12 the best option remains the prevention of herpes zoster and thus postherpetic neuralgia. 13 Two herpes zoster vaccines are currently authorized for use in Canada among adults aged 50 years or older: the recombinant subunit zoster vaccine (Shingrix) and the live attenuated zoster vaccine (Zostavax). The recombinant vaccine was approved recently (October 2017), whereas the live vaccine has been available since 2008. Clinical trials have shown that the recombinant vaccine is highly effective against herpes zoster and postherpetic neuralgia for adults aged 50 years or older (vaccine efficacy against herpes zoster 96.6% for those 50-59 yr and 97.9% for those > 70 yr) with no evidence of waning protection after 4 years. 14 Recent immunogenicity data also suggest that the immune response is maintained up to 9 years after vaccination. 15 Conversely, clinical trials and observational data have suggested that the efficacy of the live vaccine against herpes zoster decreases with older age at vaccination (from 65.5% for those 60-69 yr to 55.4% for those ≥ 70 yr 10) and wanes with increasing time since vaccination. 16-18 Although the recombinant vaccine appears to be more effective, particularly among older adults, a 2-dose schedule is recommended, compared with a 1-dose schedule for the live vaccine; this difference has implications for costs and vaccination logistics. Furthermore, although both vaccines have been shown to be safe, a significantly higher proportion of adults vaccinated RESEARCH HEALTH SERVICES

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Section: Resultsmentioning

confidence: 99%

Effectiveness and cost-effectiveness of vaccination against herpes zoster in Canada: a modelling study

Drolet

Zhou

Sauvageau

et al. 2019

CMAJ

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“…Moreover, this strong protective effect persisted for the 3.8 years of follow-up reported. HZ/su-induced immune responses remained robust for the duration of the pivotal trials and have been readily detected at 6 to 9 years after vaccination in long-term follow-up studies (18)(19)(20).…”

Section: Introductionmentioning

confidence: 97%

Th1 memory differentiates recombinant from live herpes zoster vaccines

Levin¹,

Kroehl²,

Johnson³

et al. 2018

Journal of Clinical Investigation

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The adjuvanted varicella-zoster virus (VZV) glycoprotein E (gE) subunit herpes zoster vaccine (HZ/su) confers higher protection against HZ than the live attenuated zoster vaccine (ZV). To understand the immunologic basis for the different efficacies of the vaccines, we compared immune responses to the vaccines in adults 50 to 85 years old. gE-specific T cells were very low/undetectable before vaccination when analyzed by FluoroSpot and flow cytometry. Both ZV and HZ/su increased gE-specific responses, but at peak memory response (PMR) after vaccination (30 days after ZV or after the second dose of HZ/su), gE-specific CD4+ and CD8+ T cell responses were 10-fold or more higher in HZ/su compared with ZV recipients. Comparing the vaccines, T cell memory responses, including gE-IL-2+ and VZV-IL-2+ spot-forming cells (SFCs), were higher in HZ/su recipients and cytotoxic and effector responses were lower. At 1 year after vaccination, all gE-Th1 and VZV-IL-2+ SFCs remained higher in HZ/su compared with ZV recipients. Mediation analyses showed that IL-2+ PMR were necessary for the persistence of Th1 responses to either vaccine and VZV-IL-2+ PMR explained 73% of the total effect of HZ/su on persistence. This emphasizes the biological importance of the memory responses, which were clearly superior in HZ/su compared with ZV participants.

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“…In addition to the aforementioned data, several independent health economic studies , (Merck, unpublished data, 2017), as well as immunogenicity data were presented. Long‐term immunogenicity of RZV and immunogenicity and safety of RZV in ZVL recipients were considered, with recognition that there are no standard immunologic correlates of protection for prevention of herpes zoster.…”

Section: Methodsmentioning

confidence: 99%

Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines

Dooling

Guo

Patel

et al. 2018

American Journal of Transplantation

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Carolina), a 2-dose, subunit vaccine containing recombinant glycoprotein E in combination with a novel adjuvant (AS01 B ), was approved by the Food and Drug Administration for the prevention of herpes zoster in adults aged ≥50 years. The vaccine consists of 2 doses (0.5 mL each), administered intramuscularly, 2-6 months apart (1). On October 25, 2017, the Advisory Committee on Immunization Practices (ACIP) recommended the recombinant zoster vaccine (RZV) for use in immunocompetent adults aged ≥50 years.Herpes zoster is a localized, usually painful, cutaneous eruption resulting from reactivation of latent varicella zoster virus (VZV).Herpes zoster is common: approximately one million cases occur each year in the United States (2). The incidence increases with age, from five cases per 1,000 population in adults aged 50-59 years to 11 cases per 1,000 population in persons aged ≥80 years (2).Postherpetic neuralgia, commonly defined as persistent pain for at least 90 days following the resolution of the herpes zoster rash, is the most common complication and occurs in 10%-13% of herpes zoster cases in persons aged >50 years (3,4). Among persons with herpes zoster, the risk for developing postherpetic neuralgia also increases with age (3-5).Zoster Vaccine Live (ZVL) (Zostavax, Merck and Co., Inc., Whitehouse Station, New Jersey), a 1-dose live attenuated strain of VZV, is licensed for the prevention of herpes zoster in immunocompetent adults aged ≥50 years and is recommended by the ACIP for use in immunocompetent adults aged ≥60 years (6). Since licensure, vaccine coverage has increased each year, and by 2016, 33% of adults aged ≥60 years reported receipt of the vaccine (CDC, provisional unpublished data). ACIP considered use of RZV, as well as existing recommendations, to develop vaccination policy which would be safe and reduce disease burden. This report serves as a supplement to the 2008 Prevention of Herpes Zoster Recommendations of ACIP for the use of ZVL in adults aged ≥60 years and subsequent updates (6-8); it outlines recent ACIP recommendations as well as guidance for use of RZV and ZVL in adults. the ACIP Herpes Zoster Vaccines Work Group (Work Group; see acknowledgments for members and their affiliations) participated in monthly or bimonthly teleconferences to review herpes zoster epidemiology and the evidence for the efficacy, safety, and programmatic factors of RZV and ZVL. According to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the Work Group defined critical and important outcomes, conducted a systematic review of the evidence, and subsequently reviewed and discussed findings and evidence quality (https://www.cdc.gov/vaccines/acip/ recs/grade/) (9).A cost effectiveness analysis comparing RZV, ZVL, or no vaccine was conducted by CDC from a societal perspective, using an analytic No claim to original US government works

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Persistence of Immune Response to an Adjuvanted Varicella-Zoster Virus Subunit Candidate Vaccine for up to Year 9 in Older Adults

Cited by 8 publications

References 0 publications

Effectiveness and cost-effectiveness of vaccination against herpes zoster in Canada: a modelling study

Effectiveness and cost-effectiveness of vaccination against herpes zoster in Canada: a modelling study

Th1 memory differentiates recombinant from live herpes zoster vaccines

Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines

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