Shingles Vaccine Safe and Effective for Frail Individuals

Results of a new study focused on the impact of physical frailty on recombinant zoster vaccine (RZV) clinical outcomes concluded that vaccination with recombinant herpes zoster vaccine (Shingrix; GlaxoSmithKline) is both safe and effective for a population that is all too often underrepresented in clinical trials.¹

Underrepresentation of a specific population tends to raise questions about outcomes of interventions in real-world settings, the investigators acknowledged. They noted that frailty is strongly associated with vulnerability to illness and adverse health outcomes, particularly when it comes to herpes zoster (HZ).

“Older adults are at an increased risk of having severe pain during the acute phase, and of developing complications such as postherpetic neuralgia (PHN), which can have a devastating impact on quality of life,” they wrote.1 “Particularly in frail individuals, HZ can lead to an inability to recover the lifestyle, interests, and level of functional activity that existed before HZ, and may also be associated with depression.”

The ZOE-Frailty study, funded by GlaxoSmithKline and published in the Journal of the American Geriatrics Society, analyzed data on frail and near-frail older adults collected during 2 phase 3 randomized trials of the recombinant herpes zoster vaccine. Trial participants in these 2 parent studies were divided into 2 groups: ZOE-50 (participants aged ≥ 50 years) and ZOE-70 (participants aged ≥70 years).¹

The trials were conducted concurrently at the same study sites using the same methods, and the data were pooled. More than 29,000 participants aged 50 years and over were randomized 1:1 to receive 2 doses of RZV or a placebo.¹

ZOE-Frailty investigators created a frailty index to measure the participants’ status by using the accumulation of deficits approach, which was assessed through medical histories and questionnaires recorded before participants received the first dose of the vaccine. The questionnaires included scales for general health, physical and social function, bodily pain, vitality, mental health, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.¹

The study results reveal that Shingrix’s efficacy against HZ was greater than 90% for all frailty subgroups. Additionally, the group receiving RZV demonstrated robust anti-gE antibody and gE-specific CD42+ responses. This indicates that concentrations remained above pre-vaccination levels at least 3 years post-dose 2 in all frailty subgroups. The percentage of participants in this group reporting solicited adverse events tended to decrease with increasing frailty.¹

The investigators also reported that Shingrix was highly effective in reducing the risk of HZ and associated burden of illness for all frailty subgroups.¹

“Vaccines against other infections, such as influenza and pneumococcal disease, are less effective in older or frail individuals, resulting in less benefit,” the investigators reported.1 “In contrast, a 2-dose adjuvanted recombinant zoster vaccine (Shingrix) demonstrated vaccine efficacy in preventing HZ of 97.2% in the pivotal phase 2 ZOE-50 study that enrolled adults ≥50 years, and 91.3% in the pooled ZOE-50 and ZOE-70 analysis, that enrolled adults ≥ 70 years.”

Shingrix received FDA approval in 2017 for use in immunocompetent adults aged 50 years and older. It is administered in 2 doses given 2 to 6 months apart to achieve maximum protection against shingles. Shingrix is the only shingles vaccine available in the United States.

Reference

1. Curran D, Kim JH, Matthews S, et al. Recombinant zoster vaccine is efficacious and safe in frail individuals. The Journal of the American Geriatrics Society. 2020. https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.16917