HIV/AIDS Unit, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.
University of Reims Champagne-Ardenne, Reims, France.
BMC Infect Dis. 2024 Mar 19;24(1):329. doi: 10.1186/s12879-024-09192-5.
The burden of herpes zoster (shingles) virus and associated complications, such as post-herpetic neuralgia, is higher in older adults and has a significant impact on quality of life. The incidence of herpes zoster and post-herpetic neuralgia is increased in people living with HIV (PLWH) compared to an age-matched general population, including PLWH on long-term antiretroviral therapy (ART) with no detectable viremia and normal CD4 counts. PLWH - even on effective ART may- exhibit sustained immune dysfunction, as well as defects in cells involved in the response to vaccines. In the context of herpes zoster, it is therefore important to assess the immune response to varicella zoster virus vaccination in older PLWH and to determine whether it significantly differs to that of HIV-uninfected healthy adults or younger PLWH. We aim at bridging these knowledge gaps by conducting a multicentric, international, non-randomised clinical study (SHINGR'HIV) with prospective data collection after vaccination with an adjuvant recombinant zoster vaccine (RZV) in two distinct populations: in PLWH on long-term ART (> 10 years) over 50 years of and age/gender matched controls.
We will recruit participants from two large established HIV cohorts in Switzerland and in France in addition to age-/gender-matched HIV-uninfected controls. Participants will receive two doses of RZV two months apart. In depth-evaluation of the humoral, cellular, and innate immune responses and safety profile of the RZV will be performed to address the combined effect of aging and potential immune deficiencies due to chronic HIV infection. The primary study outcome will compare the geometric mean titer (GMT) of gE-specific total IgG measured 1 month after the second dose of RZV between different age groups of PLWH and between PLWH and age-/gender-matched HIV-uninfected controls.
The SHINGR'HIV trial will provide robust data on the immunogenicity and safety profile of RZV in older PLWH to support vaccination guidelines in this population.
ClinicalTrials.gov NCT05575830. Registered on 12 October 2022. Eu Clinical Trial Register (EUCT number 2023-504482-23-00).
带状疱疹（带状疱疹）病毒及其相关并发症（如带状疱疹后神经痛）的负担在老年人中更高，对生活质量有重大影响。与年龄匹配的普通人群相比，HIV 感染者（PLWH）中带状疱疹和带状疱疹后神经痛的发病率更高，包括长期接受抗逆转录病毒治疗（ART）且无法检测到病毒血症和正常 CD4 计数的 PLWH。PLWH-即使在有效的 ART 下-可能表现出持续的免疫功能障碍，以及参与疫苗反应的细胞缺陷。因此，在带状疱疹的情况下，评估老年人 PLWH 对水痘带状疱疹病毒疫苗的免疫反应并确定其与 HIV 未感染健康成年人或年轻 PLWH 的免疫反应是否有显著差异非常重要。我们旨在通过在瑞士和法国的两个大型既定 HIV 队列中以及年龄/性别匹配的 HIV 未感染对照组中进行前瞻性数据收集，对佐剂重组带状疱疹疫苗（RZV）接种后的多中心、国际、非随机临床研究（SHINGR'HIV）来填补这些知识空白。
我们将从瑞士和法国的两个大型既定 HIV 队列中招募参与者，以及年龄/性别匹配的 HIV 未感染对照组。参与者将接受两剂 RZV，间隔两个月。将深入评估 RZV 的体液、细胞和先天免疫反应以及安全性特征，以解决衰老和慢性 HIV 感染引起的潜在免疫缺陷的综合影响。主要研究结果将比较不同年龄组 PLWH 和 PLWH 与年龄/性别匹配的 HIV 未感染对照组之间第二次 RZV 接种后 1 个月时 gE 特异性总 IgG 的几何平均滴度（GMT）。
SHINGR'HIV 试验将提供关于 RZV 在老年 PLWH 中的免疫原性和安全性特征的可靠数据，以支持该人群的疫苗接种指南。
ClinicalTrials.gov NCT05575830。于 2022 年 10 月 12 日注册。欧盟临床试验注册（EUCT 编号 2023-504482-23-00）。
