Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.

IF 0.9 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE Pub Date : 2024-01-01 DOI:10.3233/JRS-230049

Jacob Puliyel, Brian S Hooker

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引用次数: 0

Abstract

Background: The self-controlled case series (SCCS) is often used to monitor vaccine safety. The evaluation of intussusception after the rotavirus vaccine is complicated because the baseline rate varies with age. Time-varying baseline risk adjustments with data from unexposed cohorts are utilised. Self-controlled risk interval (SCRI), with a shorter observation period, can also mitigate the problem by studying a control period close to the risk period.

Objective: An Indian rotavirus vaccine has previously been studied using SCCS. The risk of intussusception in the high-risk windows (21 days after vaccination) was comparable to the background risk. The aim was to re-analyse data of an existing SCCS study using alternate statistical methods to examine vaccine safety.

Methods: We examined the mean age of intussusception in the vaccinated and the unvaccinated. We performed an SCRI analysis of the surveillance data from the SCCS study, limiting the observation period to 180 days. We analysed the time-to-intussusception from the last vaccination. Finally, we performed an SCCS analysis, excluding unvaccinated cases from the analysis.

Results: We found that the mean age of intussusception was significantly lower in the vaccinated (205 days) compared to the unvaccinated (223 days) (p-value 0.0026). The Incident Risk Ratio (IRR) on SCRI analysis was 1.62 (95% CI 1.07-2.44). There were significantly more intussusceptions in the first 30 days after vaccination compared to the next 30-day window. (92 vs 63 p-value = 0.009). We found that excluding unvaccinated infants from the SCCS analysis demonstrated significantly increased risk for the risk period 1-21 days after the 3rd dose (IRR 2.47, 95% CI 1.70-3.59). The risks of intussusception were missed in traditional SCCS analysis using unvaccinated infants as controls.

Conclusion: Traditional risk adjustments using data from unexposed cohorts in SCCS may not be appropriate for investigating the risk of intussusception where vaccination lowers the mean age of intussusception.

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轮状病毒疫苗安全性的自控风险间隔研究：研究结果和影响。

背景：自控病例系列（SCCS）通常用于监测疫苗的安全性。轮状病毒疫苗接种后肠梗阻的评估比较复杂，因为基线发病率随年龄而变化。利用未暴露人群的数据对时变基线风险进行调整。观察期较短的自控风险间隔期（SCRI）也可以通过研究接近风险期的对照期来缓解这一问题：目的：此前曾使用 SCCS 对印度轮状病毒疫苗进行过研究。高风险窗口期（接种疫苗后 21 天）发生肠套叠的风险与背景风险相当。我们的目的是使用其他统计方法重新分析现有 SCCS 研究的数据，以检查疫苗的安全性：我们研究了接种疫苗和未接种疫苗儿童肠套叠的平均发病年龄。我们对 SCCS 研究的监测数据进行了 SCRI 分析，将观察期限制为 180 天。我们分析了从最后一次接种疫苗到发生肠套叠的时间。最后，我们进行了 SCCS 分析，将未接种疫苗的病例排除在分析之外：结果：我们发现，接种疫苗者的肠套叠平均发生年龄（205 天）明显低于未接种者（223 天）（P 值为 0.0026）。根据 SCRI 分析得出的发病风险比为 1.62（95% CI 1.07-2.44）。接种后前 30 天内发生的肠套叠明显多于后 30 天。(92 vs 63 p-值 = 0.009）。我们发现，从 SCCS 分析中排除未接种疫苗的婴儿后，第 3 次接种后 1-21 天的风险期的风险明显增加（IRR 2.47，95% CI 1.70-3.59）。以未接种疫苗的婴儿为对照组进行的传统 SCCS 分析漏掉了肠套叠的风险：结论：在接种疫苗会降低肠套叠发生的平均年龄的情况下，使用 SCCS 中未暴露队列的数据进行传统的风险调整可能不适合调查肠套叠的风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-

CiteScore

2.20

自引率

17.60%

发文量

102

期刊介绍： The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed. This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety.