TOPLINE:
The adjuvanted recombinant subunit herpes zoster vaccine showed a favorable short-term safety and tolerability profile in people living with HIV (PLWH), with participants showing excellent adherence to the two-dose schedule.
METHODOLOGY:
- This prospective real-world study monitored vaccination-related adverse events (AEs) after each dose of the adjuvanted recombinant subunit herpes zoster vaccine in PLWH aged 18 years or older.
- A total of 237 PLWH (84.81% men) received at least one dose of the vaccine across six centers in Spain between June 2022 and February 2024.
- Participants recorded AEs for 10 days after each dose, along with their duration and any treatments used, and healthcare professionals later reviewed the events through a follow-up phone call.
- The primary outcome was the occurrence of AEs within 10 days after each dose, along with their duration and any treatments required to alleviate them.
- Secondary outcomes were assessing factors associated with AEs and their potential impact on adherence to the two-dose schedule.
TAKEAWAY:
- Overall, 82.7% of participants reported AEs after either dose, with local pain being the most common event: 65.82% of participants after the first dose and 52.97% after the second dose.
- Any local or systemic reactions that interfered with daily activities (grade 3 AEs) were uncommon, and no cases of Guillain-Barré syndrome were detected; reported AEs were consistent with the ones listed in the vaccine’s official technical data sheet.
- The average duration of local AEs was longer than that of systemic AEs, and participants who needed treatment had significantly longer durations for both local and systemic events (P < .001 for both).
- Demographic and clinical factors, including age, sex, CD4 cell count, and concurrent immunosuppressive therapy, were not linked to higher odds of AEs; the adherence rate was excellent, with 99.60% of the participants completing the two-dose schedule.
IN PRACTICE:
“Our study demonstrates a more favorable reactogenicity profile compared to previously published data, along with an optimal adherence rate to the two-dose vaccination schedule. These findings may be highly valuable for informing and reassuring patients about the safety of vaccination,” the authors wrote.
SOURCE:
The study was led by Matilde Zornoza Moreno, Prevention and Health Protection Service, Murcia Health Department, Murcia, Spain. It was published online on April 19, 2026, in Vaccine.
LIMITATIONS:
The sample size was relatively modest and was calculated to assess the prevalence of vaccine-related AEs rather than to determine potential associations across all analyzed variables. Data on AEs were captured by telephone follow-up rather than clinical examination.
DISCLOSURES:
This study received no specific financial support from public, commercial, or nonprofit funding agencies. Several authors disclosed participating in teaching activities or receiving financial support to attend educational events funded by GSK; one author reported serving as consultant on advisory boards for GSK.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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