PMID- 34115324 OWN - NLM STAT- MEDLINE DCOM- 20220420 LR - 20220531 IS - 1179-1942 (Electronic) IS - 0114-5916 (Print) IS - 0114-5916 (Linking) VI - 44 IP - 7 DP - 2021 Jul TI - Safety Profile of the Adjuvanted Recombinant Zoster Vaccine in Immunocompromised Populations: An Overview of Six Trials. PG - 811-823 LID - 10.1007/s40264-021-01076-w [doi] AB - INTRODUCTION: The adjuvanted recombinant zoster vaccine (RZV) has demonstrated high efficacy against herpes zoster in older adults and immunocompromised populations. We present comprehensive safety data from six clinical trials in immunocompromised populations (autologous hematopoietic stem cell transplant and renal transplant recipients, patients with hematologic malignancies, patients with solid tumors, and human immunodeficiency virus-infected adults) who are at an increased risk of herpes zoster. METHODS: In all trials, immunocompromised adults >/= 18 years of age were administered RZV or placebo. Safety was evaluated in the total vaccinated cohort. Solicited adverse events (AEs) were collected for 7 days and unsolicited AEs for 30 days after each dose. Serious AEs, fatal serious AEs, and potential immune-mediated diseases were collected from dose 1 until 12 months post-last dose or study end. Data were pooled for solicited AEs; unsolicited AEs, (fatal) serious AEs, and potential immune-mediated diseases were analyzed for each individual trial. All AEs were analyzed for sub-strata of adults 18-49 years of age and >/= 50 years of age. RESULTS: In total, 1587 (RZV) and 1529 (placebo) adults were included in the pooled total vaccinated cohort. Solicited AEs were more common after RZV than placebo, were generally more common in the younger age stratum, and were mostly mild to moderate and resolved within 3 days (median duration). Unsolicited AEs and serious AEs were in line with underlying diseases and therapies. Across studies, the percentage of adults reporting one or more unsolicited AE was comparable between RZV and placebo, irrespective of age stratum. The percentage of adults reporting one or more serious AE, fatal serious AE, or potential immune-mediated diseases was generally similar for RZV and placebo, irrespective of age stratum. Overall, no safety concerns were identified. CONCLUSIONS: Recombinant zoster vaccine has a clinically acceptable safety profile. With the previously published vaccine efficacy and immunogenicity results, these data support a favorable benefit-risk profile of RZV vaccination in immunocompromised populations who are at an increased risk of herpes zoster. FAU - Lopez-Fauqued, Marta AU - Lopez-Fauqued M AD - GSK, Avenue Fleming 20, 1300, Wavre, Belgium. FAU - Co-van der Mee, Maribel AU - Co-van der Mee M AD - GSK, Avenue Fleming 20, 1300, Wavre, Belgium. FAU - Bastidas, Adriana AU - Bastidas A AD - GSK, Avenue Fleming 20, 1300, Wavre, Belgium. AD - Current affiliation: Mithra Pharmaceuticals, Flemalle, Belgium. FAU - Beukelaers, Pierre AU - Beukelaers P AD - GSK, Avenue Fleming 20, 1300, Wavre, Belgium. FAU - Dagnew, Alemnew F AU - Dagnew AF AD - GSK, Rockville, MD, USA. AD - Bill & Melinda Gates Medical Research Institute, Cambridge, MA, USA. FAU - Fernandez Garcia, Juan Jose AU - Fernandez Garcia JJ AD - GSK, Rixensart, Belgium. FAU - Schuind, Anne AU - Schuind A AD - GSK, Rockville, MD, USA. AD - PATH, Washington DC, WA, USA. FAU - Tavares-da-Silva, Fernanda AU - Tavares-da-Silva F AUID- ORCID: 0000-0003-2411-8065 AD - GSK, Avenue Fleming 20, 1300, Wavre, Belgium. fernanda.tavares@gsk.com. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20210611 PL - New Zealand TA - Drug Saf JT - Drug safety JID - 9002928 RN - 0 (Herpes Zoster Vaccine) RN - 0 (Vaccines, Synthetic) SB - IM MH - Adult MH - Clinical Trials as Topic MH - *Herpes Zoster/prevention & control MH - *Herpes Zoster Vaccine/adverse effects MH - Herpesvirus 3, Human MH - Humans MH - *Immunocompromised Host MH - Vaccines, Synthetic/adverse effects PMC - PMC8217041 OAB - Varicella zoster virus leads to chickenpox after primary infection and herpes zoster upon reactivation of the latent virus. Older adults and immunocompromised people, whose immune system is impaired because of the age-related decline in immunity and their underlying disease and/or treatment, respectively, are at an increased risk of herpes zoster and its complications. Recombinant zoster vaccine has been approved to prevent herpes zoster and its complications in adults aged >/= 50 years in over 30 countries. In Europe, the vaccine has recently received approval to expand its use in adults aged 18 years or older who are at an increased risk of herpes zoster. We present an overview of the safety data from six clinical trials in immunocompromised patients vaccinated with recombinant zoster vaccine. We found that solicited adverse events were more common after the vaccine than placebo but that these were mild to moderate in intensity. Furthermore, the frequency of unsolicited adverse events was similar between the vaccine and placebo, and most of the reported adverse events and severe adverse events (e.g., infections or tumors) could be attributed to the pre-existent diseases and/or therapies. As such, no safety concern was identified following the review of the available clinical data. This overview, together with the published efficacy data in the prevention of herpes zoster and the vaccine immunogenicity, provides useful medical information and supports the use of the recombinant zoster vaccine in an immunocompromised population at an increased risk of herpes zoster. OABL- eng COIS- Maribel Co-van der Mee, Pierre Beukelaers, Juan Jose Fernandez Garcia, and Fernanda Tavares-da-Silva are employed by the GSK group of companies. Marta Lopez-Fauqued, Juan Jose Fernandez Garcia, Adriana Bastidas, Alemnew F. Dagnew, and Anne Schuind were employees of the GSK group of companies during the design, initiation, conduct of the study and/or interpretation of the data. During the conduct of the study, Pierre Beukelaers, Juan Jose Fernandez Garcia, and Fernanda Tavares-da-Silva report personal fees from the GSK group of companies. Adriana Bastidas, Pierre Beukelaers, Alemnew F. Dagnew, Anne Schuind, and Fernanda Tavares-da-Silva hold shares in the GSK group of companies. EDAT- 2021/06/12 06:00 MHDA- 2022/04/21 06:00 PMCR- 2021/06/11 CRDT- 2021/06/11 12:28 PHST- 2021/04/23 00:00 [accepted] PHST- 2021/06/12 06:00 [pubmed] PHST- 2022/04/21 06:00 [medline] PHST- 2021/06/11 12:28 [entrez] PHST- 2021/06/11 00:00 [pmc-release] AID - 10.1007/s40264-021-01076-w [pii] AID - 1076 [pii] AID - 10.1007/s40264-021-01076-w [doi] PST - ppublish SO - Drug Saf. 2021 Jul;44(7):811-823. doi: 10.1007/s40264-021-01076-w. Epub 2021 Jun 11.