Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals

Curran, Desmond; Kim, Joon H.; Matthews, Sean; Dessart, Christophe; Levin, Myron J.; Oostvogels, Lidia; Riley, Megan; Schmader, Kenneth E.; Cunningham, Anthony L.; McNeil, Shelly; Schuind, Anne; Andrew, Melissa K.

doi:10.1111/jgs.16917

Cited by 39 publications

(47 citation statements)

References 29 publications

(84 reference statements)

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“…Vaccine efficacy did not vary with the presence of any pre-morbid condition or when multiple conditions, up to six, were present 75. Frailty, measured directly using the Cumulative Deficits approach, or by surrogate methods, did not diminish efficacy against herpes zoster in the ZOE participants 6476…”

Section: Vaccines For Herpes Zostermentioning

confidence: 93%

Vaccines for older adults

Cunningham

McIntyre

Subbarao

et al. 2021

BMJ

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The proportion of the global population aged 65 and older is rapidly increasing. Infections in this age group, most recently with SARS-CoV-2, cause substantial morbidity and mortality. Major improvements have been made in vaccines for older people, either through the addition of novel adjuvants—as in the new recombinant zoster vaccine and an adjuvanted influenza vaccine—or by increasing antigen concentration, as in influenza vaccines. In this article we review improvements in immunization for the three most important vaccine preventable diseases of aging. The recombinant zoster vaccine has an efficacy of 90% that is minimally affected by the age of the person being vaccinated and persists for more than four years. Increasing antigen dose or inclusion of adjuvant has improved the immunogenicity of influenza vaccines in older adults, although the relative effectiveness of the enhanced influenza vaccines and the durability of the immune response are the focus of ongoing clinical trials. Conjugate and polysaccharide pneumococcal vaccines have similar efficacy against invasive pneumococcal disease and pneumococcal pneumonia caused by vaccine serotypes in older adults. Their relative value varies by setting, depending on the prevalence of vaccine serotypes, largely related to conjugate vaccine coverage in children. Improved efficacy will increase public confidence and uptake of these vaccines. Co-administration of these vaccines is feasible and important for maximal uptake in older people. Development of new vaccine platforms has accelerated following the arrival of SARS-CoV-2, and will likely result in new vaccines against other pathogens in the future.

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Section: Vaccines For Herpes Zostermentioning

confidence: 93%

Vaccines for older adults

Cunningham

McIntyre

Subbarao

et al. 2021

BMJ

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“…Newer adjuvants may overcome age-related defects in innate immunity including frail individuals. 12,13 Cell-mediated immunity (CMI) is particularly important in the setting of frailty and immunosenescence so vaccines should be designed to optimize CMI responses. 11,14 Along with this, vaccine immunogenicity trials need to include measures of CMI that better reflect the immune responses of frail older adults.…”

Section: Vaccine Designmentioning

confidence: 99%

“…18 Relevant to the challenge of immunosenescence, evidence from other vaccines suggests that frail older adults may benefit from higher doses of antigen (eg, high-dose influenza vaccine) [19][20][21] or inclusion of adjuvants to stimulate immune responses (eg, adjuvanted influenza vaccine, recombinant shingles vaccine). 13,18,22,23 If we do not include older frail participants in vaccine studies, this opportunity to optimize the products for their needs will be missed.…”

Section: Trial Designmentioning

confidence: 99%

Considering Frailty in SARS-CoV-2 Vaccine Development: How Geriatricians Can Assist

Andrew¹,

Schmader²,

Rockwood³

et al. 2021

CIA

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The COVID-19 pandemic has disproportionately impacted frail older adults, especially residents of long-term care (LTC) facilities. This has appropriately led to prioritization of frail older adults and LTC residents, and those who care for them, in the vaccination effort against COVID-19. Older adults have distinct immunological, clinical, and practical complexity, which can be understood through a lens of frailty. Even so, frailty has not been considered in studies of COVID-19 vaccines to date, leading to concerns that the vaccines have not been optimally tailored for and evaluated in this population even as vaccination programs are being implemented. This is an example of how vaccines are often not tested in Phase 1/2/3 clinical trials in the people most in need of protection. We argue that geriatricians, as frailty specialists, have much to contribute to the development, testing and implementation of COVID-19 vaccines in older adults. We discuss roles for geriatricians in ten stages of the vaccine development process, covering vaccine design, trial design, trial recruitment, establishment and interpretation of illness definitions, safety monitoring, consideration of relevant health measures such as frailty and function, analysis methods to account for frailty and differential vulnerability, contributions in regulatory and advisory roles, post-marketing surveillance, and program implementation and public health messaging. In presenting key recommendations pertinent to each stage, we hope to contribute to a dialogue on how to push the field of vaccinology to embrace the complexity of frailty. Making vaccines that can benefit frail older adults will benefit everyone in the fight against COVID-19.

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“…Frailty is increasingly understood to affect older adults' responses to vaccines for infections such as influenza, shingles, and pneumococcus. [9][10][11] Even when a measure of frailty has not been included in a study upfront, generation of a robust frailty measure using data already collected is possible. 10,12 A plan for how to consider frailty in COVID-19 vaccine development is important.…”

mentioning

confidence: 99%

“…[9][10][11] Even when a measure of frailty has not been included in a study upfront, generation of a robust frailty measure using data already collected is possible. 10,12 A plan for how to consider frailty in COVID-19 vaccine development is important. Involving geriatricians could bring a key lens to assist with planning these ongoing studies focusing on older adults and interpreting the results.…”

mentioning

confidence: 99%

Age and frailty in COVID-19 vaccine development

Andrew

McElhaney

2020

The Lancet

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Age and frailty in COVID-19 vaccine development Older adults, particularly those who are frail or living in long-term care facilities, have been disproportionately affected by the COVID-19 pandemic. 1 Vaccines that are safe and effective in this population have been eagerly anticipated. In The Lancet, Maheshi Ramasamy and colleagues present results of the safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine in older adults (those older than 55 years). 2 Their results are part of a larger single-blind, randomised, controlled, phase 2/3 trial of the ChAdOx1 nCoV-19 vaccine (which is a replication-defective chimpanzee adenovirus-vector vaccine) with a MenACWY menin gococcal vaccine comparison group. The study design was complex, with participants randomly assigned using block randomisation to one of ten different groups, and older adults were only enrolled after initial determination of safety in the youngest age group (aged 18-55 years). Participants in the two older age groups (aged 56-69 and ≥70 years) were further randomly assigned to receive either one dose (day 0) or two doses (day 0 and a boost dose on day 28) of vaccine. The ChAdOx1 nCoV-19 groups were also sequentially recruited to receive either a low dose or (after demonstration of safety) a standard dose of the vaccine. In this immunogenicity subgroup of the larger study, 560 healthy adults were included, distributed among the three age groups (160 participants aged 18-55 years, of whom 100 received the COVID-19 vaccine; 160 aged 56-69 years, of whom 120 received the COVID-19 vaccine, and 240 aged ≥70 years, of whom 200 received the COVID-19 vaccine). 280 (51%) of 552 analysed participants were female and the median age in the 18-55 years group was 43•0 years (IQR 33•6-48•0), in the 56-69 years group was 60•0 years (57•5-63•0), and in the 70 years and older group was 73•0 years (71•0-76•0). For 7 days after each dose, participants completed diary cards for solicited local and systemic adverse events. Serious adverse events were recorded and will be monitored for 1 year. Severity of reactions and adverse events was graded as mild, moderate, or severe, depending on their effect on daily activities. Immune responses were measured using assays of anti-spike protein IgG and neutralising antibody titres for humoral immunity and IFN-γ enzyme-linked immunospot (ELISpot) for cell-mediated immunity.

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Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals

Cited by 39 publications

References 29 publications

Vaccines for older adults

Vaccines for older adults

Considering Frailty in SARS-CoV-2 Vaccine Development: How Geriatricians Can Assist

Age and frailty in COVID-19 vaccine development

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