A population database analysis to estimate the varicella vaccine effectiveness in children < 14 years in a high vaccination coverage area from 2004 to 2022

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2024-09-26 DOI:10.1016/j.vaccine.2024.126387

Elisa Barbieri , Silvia Cocchio , Patrizia Furlan , Antonio Scamarcia , Luigi Cantarutti , Daniele Dona' , Carlo Giaquinto , Vincenzo Baldo

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Abstract

Introduction

In the Veneto Region of Italy, universal varicella vaccination (VV) started in 2007 with a two-dose schedule at 12–15 months and 5–6 years of age achieving 90 % coverage in 2019. The study aimed at evaluating the vaccine effectiveness (VE) in children using a primary-care database

Methods

This retrospective analysis used Pedianet, a comprehensive database of 73 family paediatricians in the Veneto Region. Incidence rates (IR) of varicella were evaluated in children aged <14 years enrolled since birth, between January 2004 to April 2022. Cases were classified as breakthrough if happening beyond 42 days post-VV. Complications and prescription were evaluated. Subject were followed up from 2004 or the enrollment date, until the end of assistance/study or the first or second VV dose. Kaplan-Meier curves and log-rank tests were used to compare the varicella incidence by vaccination status. Hazard ratios of varicella infection, adjusted (aHRs) for sex, vaccinal status, age group, prematurity and socioeconomic status were estimated with Cox's regression. VE for one and two VV doses was defined as 1-aHR*.

Results

36,498 children, followed for 233,508 person-years from 2004 to 2022 experienced 1006 cases of varicella (13 complicated and 35 breakthrough). Younger children had a higher risk of experiencing varicella compared to children aged >7 years, irrespective of their vaccination status. Indeed, the IR increased from 5.5 to 19.5 × 1000 person-years and from 1.1 to 5.4 × 1000 person-years in unvaccinated and vaccinated children aged <12 months versus those aged 5–6 years, respectively. Varicella VE was 83.4 % and 94.7 % in those vaccinated with one and two doses. After six years, the cumulative probability of experiencing varicella was 10.7 % for unvaccinated subjects, and 2.5 % and 0.4 % for those vaccinated with one and two-doses (log-rank test, p < 0.001).

Conclusions

Two-dose schedule VV is effective in drastically reduce varicella episodes. Breakthrough varicella episodes remain rare events.

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人口数据库分析：估算 2004 年至 2022 年疫苗接种高覆盖率地区 14 岁以下儿童接种水痘疫苗的效果

导言意大利威尼托大区从 2007 年开始普及水痘疫苗接种 (VV)，在 12-15 个月和 5-6 岁时各接种两剂，到 2019 年达到 90% 的覆盖率。这项研究旨在利用初级保健数据库评估儿童接种疫苗的有效性（VE）。方法这项回顾性分析使用了威尼托大区 73 个家庭儿科医生的综合数据库 Pedianet。对 2004 年 1 月至 2022 年 4 月期间出生的 14 岁儿童的水痘发病率（IR）进行了评估。水痘后超过 42 天的病例被归类为突破性病例。并对并发症和处方进行了评估。受试者从 2004 年或注册日期开始接受随访，直至援助/研究结束或第一次或第二次静脉注射结束。卡普兰-梅耶曲线和对数秩检验用于比较不同疫苗接种情况下的水痘发病率。根据性别、疫苗接种情况、年龄组、早产儿和社会经济状况调整后的水痘感染危险比（aHRs）采用 Cox 回归法进行估算。结果从 2004 年到 2022 年，36498 名儿童在 233508 人年的随访中感染了 1006 例水痘（13 例复杂性水痘和 35 例突破性水痘）。与 7 岁儿童相比，年龄较小的儿童发生水痘的风险更高，无论其疫苗接种情况如何。事实上，未接种疫苗和接种疫苗的 12 个月儿童与 5-6 岁儿童相比，IR 分别从 5.5 × 1000 人年增加到 19.5 × 1000 人年，从 1.1 × 1000 人年增加到 5.4 × 1000 人年。接种一剂和两剂疫苗的儿童的水痘 VE 分别为 83.4% 和 94.7%。六年后，未接种者发生水痘的累积概率为 10.7%，接种一剂和两剂者分别为 2.5% 和 0.4%（log-rank 检验，p <0.001）。结论两剂水痘疫苗可有效减少水痘发病，但突破性水痘发病仍然很少见。

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

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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