Division of Geriatrics, Department of Medicine and Center for the Study of Aging, Duke University School of Medicine, Durham, North Carolina.
Geriatric Research Education and Clinical Center, Durham Veterans Affairs Health Care System, Durham, North Carolina.
JAMA Netw Open. 2024 Oct 1;7(10):e2440817. doi: 10.1001/jamanetworkopen.2024.40817.
Quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) and adjuvanted recombinant zoster vaccine (RZV) contain novel adjuvants. Data are limited on the comparative safety, reactogenicity, and health-related quality of life (HRQOL) effects of the simultaneous administration of these vaccines.
To compare the safety and reactogenicity after simultaneous doses of RZV and aIIV4 administration (opposite arms) with simultaneous doses of RZV with quadrivalent high-dose inactivated influenza vaccine [HD-IIV4]).
DESIGN, SETTING, AND PARTICIPANTS: This randomized blinded clinical trial was conducted during the 2021-2022 and 2022-2023 influenza seasons at 2 centers in the US among community-dwelling adults aged 65 years or older. Analysis was performed on an intention-to-treat basis.
Simultaneous intramuscular administration of RZV dose 1 and aIIV4 or HD-IIV4 in opposite arms after age stratification (65-69 and ≥70 years) and randomization.
The primary outcome was the proportions of participants with 1 or more severe solicited reactions during days 1 to 8, using a noninferiority test (10% noninferiority margin). Additional measures included serious adverse events and adverse events of clinical interest during days 1 to 43 of the study period.
A total of 267 adults (median age, 71 years [range, 65-92 years]; 137 men [51.3%]) were randomized; 130 received simultaneous RZV and aIIV4, and 137 received simultaneous RZV and HD-IIV4. The proportion of patients reporting 1 or more severe reactions after simultaneous administration of RZV and aIIV4 (15 of 115 [11.5%]) was noninferior compared with simultaneous RZV and HD-IIV4 (17 of 119 [12.5%]) (absolute difference, -1.0% [95% CI, -8.9% to 7.1%]). There were no significant differences in the number of serious adverse events or adverse events of clinical interest between the groups.
In this clinical trial of simultaneous doses of RZV and aIIV4 compared with simultaneous doses of RZV and HD-IIV4, overall safety findings were similar between groups. From a safety standpoint, this study supports the simultaneous administration of RZV and aIIV4 among older adults.
ClinicalTrials.gov Identifier: NCT05007041.
四价佐剂灭活流感疫苗（aIIV4）和佐剂重组带状疱疹疫苗（RZV）含有新型佐剂。关于同时接种这些疫苗的安全性、反应原性和健康相关生活质量（HRQOL）影响的数据有限。
比较 RZV 和 aIIV4 （对侧臂）同时给药与 RZV 与四价高剂量灭活流感疫苗[HD-IIV4]同时给药的安全性和反应原性。
设计、地点和参与者：这项随机、双盲临床试验在美国的两个中心进行，在 2021-2022 年和 2022-2023 年流感季节期间，纳入了社区居住的 65 岁或以上的成年人。分析采用意向治疗原则。
在年龄分层（65-69 岁和≥70 岁）和随机分组后，同时在对侧臂肌内注射 RZV 剂量 1 和 aIIV4 或 HD-IIV4。
主要结局是在第 1 天至第 8 天期间，使用非劣效性检验（10%非劣效性边界）评估参与者中 1 个或多个严重不良事件的比例。其他测量指标包括研究期间第 1 天至第 43 天的严重不良事件和临床相关不良事件。
共有 267 名成年人（中位年龄 71 岁[范围，65-92 岁]；137 名男性[51.3%]）被随机分组；130 名接受了 RZV 和 aIIV4 同时给药，137 名接受了 RZV 和 HD-IIV4 同时给药。接受 RZV 和 aIIV4 同时给药的患者报告 1 个或多个严重不良反应的比例（115 例中有 15 例[11.5%]）与接受 RZV 和 HD-IIV4 同时给药的患者相似（119 例中有 17 例[12.5%]）（绝对差值，-1.0%[95%CI，-8.9%至 7.1%]）。两组之间严重不良事件或临床相关不良事件的数量无显著差异。
在这项比较 RZV 和 aIIV4 同时给药与 RZV 和 HD-IIV4 同时给药的临床试验中，两组的总体安全性发现相似。从安全性角度来看，这项研究支持老年人同时接种 RZV 和 aIIV4。
ClinicalTrials.gov 标识符：NCT05007041。
