Randomized, Phase III Clinical Trial to Assess the Immunogenicity and Safety of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine Co-Administered With a Seasonal Quadrivalent-Inactivated Influenza Vaccine in Adults Aged 50 Years and Older

Schwarz, Tino F.; Aggarwal, Naresh; Moeckesch, Beate; Schenkenberger, Isabelle; Claeys, Carine; Godeaux, Olivier; Grupping, Katrijn; Heineman, Thomas C.; Oostvogels, Lidia; Steen, Peter van; Lal, Himal

doi:10.1093/ofid/ofw172.614

Cited by 4 publications

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“…Additional Phase III studies in adults 50+ YOA have evaluated RZV coadministered with quadrivalent influenza vaccine or with 23-valent pneumococcal polysaccharide vaccine [76,87]. Results indicate that coadministration with both vaccines was well tolerated and immunogenic, and no immunologic interference between the administered antigens has been observed [76,87]. A study to assess coadministration with reduced antigen content combined diphtheria-tetanus and acellular pertussis vaccine was recently completed (NCT02052596).…”

Section: Coadministrationmentioning

confidence: 99%

Development of adjuvanted recombinant zoster vaccine and its implications for shingles prevention

Lecrenier

Beukelaers

Colindres

et al. 2018

Expert Review of Vaccines

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GSK has developed a two-dose adjuvanted recombinant zoster vaccine (Shingrix, RZV) to protect people aged ≥50 years (50+) against herpes zoster (HZ) and its complications. RZV showed >90% efficacy against HZ, sustained over 4 years of follow-up, in all studied age groups. Areas covered: This article reviews the scientific rationale underlying the design of RZV; the clinical evidence demonstrating immunogenicity, safety, and efficacy in persons 50+; and the public health implications and cost-effectiveness. Expert commentary: A decline in varicella zoster virus (VZV) immunity is associated with increased risk of HZ in adults 50+ and immunocompromised individuals. RZV was designed to restore levels of anti-VZV cellular and humoral immunity to prevent VZV reactivation. RZV includes the recombinant gE glycoprotein antigen, and Adjuvant System AS01 which promotes cellular and antibody responses. In two Phase III studies in subjects aged 50+ and 70+ years, RZV efficacy against HZ compared to placebo was >90% and ≥89% against post-herpetic neuralgia (PHN). RZV is expected to dramatically impact HZ morbidity including its complications, and associated health-care costs. In the US population aged 50+ years, vaccination with RZV can be cost-effective compared to no vaccination and cost-saving compared to the currently available live-attenuated HZ vaccine (Zostavax, Merck).

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Section: Coadministrationmentioning

confidence: 99%

Development of adjuvanted recombinant zoster vaccine and its implications for shingles prevention

Lecrenier

Beukelaers

Colindres

et al. 2018

Expert Review of Vaccines

Self Cite

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“…Reassuringly, serious adverse events, immune-mediated diseases and deaths across the entire study period were reported equally between the vaccinated and placebo groups in both ZOE trials. Initial results from a multi-country randomized trial among 828 adults aged ≥50 years, suggest that coadministration of HZ/su with an influenza vaccine (quadrivalent inactivated influenza vaccine, IIV4) is well tolerated [109]. …”

Section: Newer Developments In Zoster Vaccinesmentioning

confidence: 99%

Varicella and herpes zoster vaccine development: lessons learned

Warren‐Gash

Forbes

Breuer

2017

Expert Review of Vaccines

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Introduction: Before vaccination, varicella zoster virus (VZV), which is endemic worldwide, led to almost universal infection. This neurotropic virus persists lifelong by establishing latency in sensory ganglia, where its reactivation is controlled by VZV-specific T-cell immunity. Lifetime risk of VZV reactivation (zoster) is around 30%. Vaccine development was galvanised by the economic and societal burden of VZV, including debilitating zoster complications that largely affect older individuals. Areas covered: We describe the story of development, licensing and implementation of live attenuated vaccines against varicella and zoster. We consider the complex backdrop of VZV virology, pathogenesis and immune responses in the absence of suitable animal models and examine the changing epidemiology of VZV disease. We review the vaccines’ efficacy, safety, effectiveness and coverage using evidence from trials, observational studies from large routine health datasets and clinical post-marketing surveillance studies and outline newer developments in subunit and inactivated vaccines. Expert commentary: Safe and effective, varicella and zoster vaccines have already made major inroads into reducing the burden of VZV disease globally. As these live vaccines have the potential to reactivate and cause clinical disease, developing alternatives that do not establish latency is an attractive prospect but will require better understanding of latency mechanisms.

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Herpes zoster prevention: A difficult problem to solve

Esposito

Principi

2018

Vaccine

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Randomized, Phase III Clinical Trial to Assess the Immunogenicity and Safety of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine Co-Administered With a Seasonal Quadrivalent-Inactivated Influenza Vaccine in Adults Aged 50 Years and Older

Cited by 4 publications

References 0 publications

Development of adjuvanted recombinant zoster vaccine and its implications for shingles prevention

Development of adjuvanted recombinant zoster vaccine and its implications for shingles prevention

Varicella and herpes zoster vaccine development: lessons learned

Herpes zoster prevention: A difficult problem to solve

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