在科伦-波恩队列中，HIV 感染者对佐剂季节性 H1N1 疫苗的接受程度和耐受性。

Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort.

机构信息

University of Cologne, Department of Internal Medicine I, Kerpener Str. 62, 50924 Köln, Germany.

出版信息

Eur J Med Res. 2011 Jul 25;16(7):289-94. doi: 10.1186/2047-783x-16-7-289.

DOI:10.1186/2047-783x-16-7-289

PMID:21813369

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3352000/

Abstract

OBJECTIVE

To evaluate the acceptance and tolerability of the nH1N1 2009 vaccine in HIV-positive individuals.

METHOD

758 patients were included in this prospective study. Different study populations were formed: The Tolerability Study Group consists of HIV-infected patients who visited three outpatient clinics (Cologne, Bonn, Freiburg) during a predefined time period. Patients were offered nH1N1 vaccination. Those accepting were administered a standard dose AS03 adjuvant nH1N1 vaccine. Questionnaires to report side effects occurring within 7 days after immunization were handed out. In a substudy conducted during the same time period, acceptance towards immunization was recorded. This Acceptance Study Group consists of all HIV-infected patients visiting the Cologne clinic. They were offered vaccination. In case of refusal, motivation was recorded.

RESULTS

In the Tolerability Study Group, a total of 475 patient diaries returned in the three study centres could be evaluated, 119 of those (25%) reported no side effects. Distribution of symptoms was as follows: Pain 285/475 patients (60%), swelling 96 (20%), redness 54 (11%), fever 48/475 (10%), muscle/joint ache 173 (36%), headache 127 (27%), and fatigue 210 (44%). Association of side effects with clinical data was calculated for patients in Cologne and Bonn. Incidence of side effects was significantly associated with CDC stages A, B compared to C, and with a detectable viral load (>50 copies/mL). No correlation was noted for CD4 cell count, age, gender or ethnicity. - In the Acceptance Study Group, 538 HIV-infected patients were offered vaccination, 402 (75%) accepted, while 136 (25%) rejected. Main reasons for rejection were: Negative media coverage (35%), indecisiveness with preference to wait until a later date (23%), influenza not seen as personal threat (19%) and scepticism towards immunization in general (10%).

CONCLUSION

A total of 622 HIV-infected patients were vaccinated against nH1N1-influenza in the three study centres. No severe adverse events were reported. The tolerability was in most parts comparable to general population. Acceptance rate towards influenza vaccination was high (75%). Those refusing the immunization mentioned negative media coverage as the major influence on their decision.

摘要

目的

评估甲型 H1N1 2009 流感疫苗在 HIV 阳性个体中的可接受性和耐受性。

方法

本前瞻性研究纳入了 758 例患者。形成了不同的研究人群：耐受性研究组由在规定时间内访问三个门诊（科隆、波恩、弗赖堡）的 HIV 感染患者组成。为患者提供了甲型 H1N1 疫苗接种。接受者给予 AS03 佐剂标准剂量的甲型 H1N1 疫苗。发放了报告接种后 7 天内发生的不良反应的问卷。在同一时期进行的一项子研究中，记录了对免疫接种的接受程度。该接受研究组由所有访问科隆诊所的 HIV 感染患者组成。为他们提供了疫苗接种。如果拒绝，记录拒绝的原因。

结果

在耐受性研究组中，可评估来自三个研究中心的共 475 例患者日记，其中 119 例（25%）报告无不良反应。症状分布如下：疼痛 285/475 例（60%），肿胀 96 例（20%），发红 54 例（11%），发热 48/475 例（10%），肌肉/关节疼痛 173 例（36%），头痛 127 例（27%），疲劳 210 例（44%）。为科隆和波恩的患者计算了不良反应与临床数据的关联。与 C 期相比，A 期和 B 期患者的不良反应发生率显著更高，且与可检测到的病毒载量（>50 拷贝/mL）相关。CD4 细胞计数、年龄、性别或种族与不良反应无相关性。在接受研究组中，538 例 HIV 感染患者被提供疫苗接种，402 例（75%）接受，而 136 例（25%）拒绝。拒绝的主要原因是：负面媒体报道（35%），犹豫不决，倾向于等待以后再接种（23%），流感未被视为个人威胁（19%），以及普遍对免疫接种持怀疑态度（10%）。