A Phase 1/2 Clinical Trial Evaluating Safety and Immunogenicity of a Varicella Zoster Glycoprotein E Subunit Vaccine Candidate in Young and Older Adults

Leroux-Roels, Isabel; Leroux‐Roels, Geert; Clement, Frédéric; Vandepapelière, Pierre; Vassilev, Ventzislav; Ledent, Edouard; Heineman, Thomas C.

doi:10.1093/infdis/jis497

Cited by 131 publications

(123 citation statements)

References 30 publications

Supporting

Mentioning

108

Contrasting

Unclassified

Order By: Relevance

“…This finding is consistent with the results of ZOE-50, in which vaccine efficacy against herpes zoster was found to be similar in all age groups (50 to 59, 60 to 69, and ≥70 years of age), but it contrasts with the efficacy of the approved live attenuated vaccine (Zostavax), which was found to decline with increasing age: 70% in adults 50 to 59 years of age, 64% in adults 60 to 69 years of age, 41% in adults 70 to 79 years of age, and 18% in adults 80 years of age or older. 24,25 In the Shingles Prevention Study, the live attenuated herpes zoster vaccine appeared to provide additional protection against postherpetic neuralgia beyond preventing herpes zoster (among adults 60 years of age or older, 51% vaccine efficacy against herpes zoster vs. 67% vaccine efficacy against postherpetic neuralgia).…”

Section: Discussionmentioning

confidence: 99%

“…2,18,19 An investigational herpes zoster subunit vaccine (HZ/su; GSK Vaccines) containing VZV glycoprotein E and the AS01 B adjuvant system is being evaluated for the prevention of herpes zoster and postherpetic neuralgia in adults 50 years of age or older. [20][21][22][23][24][25] A previous trial (Zoster Efficacy Study in Adults 50 Years of Age or Older showed that HZ/su had a vaccine efficacy against herpes zoster of 97.2%, which was consistent across all age groups. 26 Although 24% of the participants in ZOE-50 were 70 years of age or older, the trial was not intended to definitively assess vaccine efficacy against herpes zoster or postherpetic neuralgia in this age group.…”

mentioning

confidence: 91%

“…30,31 Accordingly, HZ/su induces strong glycoprotein E-specific immune responses, including CD4+ T-cell responses, that are preserved with age. 20,24 Moreover, the robustness of the immune responses to glycoprotein E are attributable to the action of the AS01 B adjuvant system, which has also been shown to enhance CD4+ T-cell and humoral immune responses to subunit antigens from other pathogens. 32,33 Together, these results suggest that such adjuvants have the potential to improve the efficacy of vaccines that are intended for use in older adults and other populations that may otherwise have a lower response to vaccination.…”

mentioning

confidence: 99%

See 2 more Smart Citations

Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

Lal²,

et al. 2016

Self Cite

View full text Add to dashboard Cite

BACKGROUNDA trial involving adults 50 years of age or older showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01 B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older . METHODSThis randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50. RESULTSIn ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups. CONCLUSIONSIn our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. ( 1020T h e ne w e ngl a nd jou r na l o f m e dicine H erpes zoster, or shingles, results from the reactivation of latent varicellazoster virus (VZV) and typically manifests as a vesicular, painful dermatomal rash.

show abstract

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 91%

mentioning

confidence: 99%

See 1 more Smart Citation

Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

Lal²,

et al. 2016

Self Cite

View full text Add to dashboard Cite

show abstract

“…A pivotal phase III study to assess the efficacy of the investigational vaccine for the prevention of shingles has met its primary endpoint and showed that HZ/su reduced the risk of shingles by 97.2% in adults aged 50 y and older compared with placebo. 93 An efficacy study on this vaccine (the Zoster Efficacy study ZOE-50), which was initiated in August 2010, is ongoing in 18 countries and involves more than 16,000 individuals.…”

Section: Zoster Vaccinationmentioning

confidence: 99%

“…113 The adjuvanted VZV gE subunit vaccine will be the vaccine of choice for immunocompromised persons. 93 …”

Section: Varicella (V) and Zoster Vaccinationmentioning

confidence: 99%

Recommended immunization schedules for adults: Clinical practice guidelines by the Escmid Vaccine Study Group (EVASG), European Geriatric Medicine Society (EUGMS) and the World Association for Infectious Diseases and Immunological Disorders (WAidid)

Esposito

Bonanni

Maggi

et al. 2016

Human Vaccines & Immunotherapeutics

View full text Add to dashboard Cite

Rapid population aging has become a major challenge in the industrialized world and progressive aging is a key reason for making improvement in vaccination a cornerstone of public health strategy. An increase in age-related disorders and conditions is likely to be seen in the near future, and these are risk factors for the occurrence of a number of vaccine-preventable diseases. An improvement in infectious diseases prevention specifically aimed at adults and the elderly can therefore also decrease the burden of these chronic conditions by reducing morbidity, disability, hospital admissions, health costs, mortality rates and, perhaps most importantly, by improving the quality of life. Among adults, it is necessary to identify groups at increased risk of vaccine-preventable diseases and highlight the epidemiological impact and benefits of vaccinations using an evidence-based approach. This document provides clinical practice guidance on immunization for adults in order to provide recommendations for decision makers and healthcare workers in Europe. Although immunization is considered one of the most impactful and cost-effective public health measures that can be undertaken, vaccination coverage rates among adults are largely lower than the stated goal of 95% among adults, and stronger efforts are needed to increase coverage in this population. Active surveillance of adult vaccine-preventable diseases, determining the effectiveness of the vaccines approved for marketing in the last 5 y, the efficacy and safety of vaccines in immunocompromised patients, as well as in pregnant women, represent the priorities for future research.

show abstract

Vaccines for post-exposure prophylaxis against varicella (chickenpox) in children and adults

Macartney

Heywood

McIntyre

2014

Cochrane Database of Systematic Reviews

View full text Add to dashboard Cite

BACKGROUND: Live attenuated varicella vaccines for the prevention of varicella (chickenpox) has been demonstrated both in randomised controlled trials (RCTs) and in population-based immunisation programmes in countries such as the United States. However, many countries do not routinely immunise children against varicella, and exposures continue to occur. Although the disease is often mild, complications such as secondary bacterial infection, pneumonitis and encephalitis occur in about 1% of cases, usually leading to hospitalisation. The use of varicella vaccine in persons who have recently been exposed to the varicella zoster virus has been studied as a form of post-exposure prophylaxis (PEP). OBJECTIVE: To assess the efficacy and safety of vaccines for use as PEP for the prevention of varicella in children and adults. CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW: We searched the Cochrane Central Register of Controlled Trials (CENTRAL)

show abstract

A Phase 1/2 Clinical Trial Evaluating Safety and Immunogenicity of a Varicella Zoster Glycoprotein E Subunit Vaccine Candidate in Young and Older Adults

Abstract: In this study, HZ/su adjuvanted subunit vaccine was well tolerated and more immunogenic than a live attenuated VZV vaccine. Clinical Trial registration. NCT00492648 and NCT00492648.

Cited by 131 publications

References 30 publications

Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

Recommended immunization schedules for adults: Clinical practice guidelines by the Escmid Vaccine Study Group (EVASG), European Geriatric Medicine Society (EUGMS) and the World Association for Infectious Diseases and Immunological Disorders (WAidid)

Vaccines for post-exposure prophylaxis against varicella (chickenpox) in children and adults

Contact Info

Product

Resources

About