在埃塞俄比亚开展的一项前瞻性多中心研究，研究内容是乙肝出生剂量疫苗联合或不联合乙肝免疫球蛋白在预防乙肝病毒母婴传播方面的作用。

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2024-10-19 DOI:10.1016/j.vaccine.2024.126461

Mebrihit Arefaine , Asgeir Johannessen , Tilahun Teklehaymanot , Adane Mihret , Dawit Hailu Alemayehu , Mahlet Osman , Andargachew Mulu , Nega Berhe

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引用次数: 0

摘要

背景：从历史上看，乙型肝炎病毒（HBV）的母婴传播（MTCT）在非洲并不常见，这导致非洲大陆对出生剂量接种 HBV 疫苗持勉强态度。由于随机试验不符合伦理道德，因此需要真实的数据来评估 HBV 出生剂量疫苗在非洲的效果：方法：2019 年 1 月至 2021 年 5 月，在埃塞俄比亚开展了一项针对乙型肝炎表面抗原（HBsAg）阳性孕妇及其婴儿的多中心、前瞻性观察研究。作为常规产前护理和/或分娩的一部分，对孕妇进行了 HBsAg 和 HIV 筛查，HBsAg 阳性、HIV 阴性的孕妇被纳入研究。建议接种 HBV 出生剂量疫苗和乙型肝炎免疫球蛋白 (HBIg)，但并非所有新生儿都接种，因为这不是国家政策。不过，所有婴儿都在 6、10 和 14 周大时接种了五价 HBV 疫苗。疫苗接种情况根据产房记录和婴儿疫苗接种证书进行确认。婴儿在 9 个月大时接受 HBsAg 检测，检测结果呈阳性即为母婴传播的证据：在 290 名 HBsAg 阳性的孕妇中，有 168 对母婴在 9 个月的随访中返回并被纳入本次分析。在 112 名接种了含 HBIg 出生剂量疫苗的婴儿中，有 2 人（1.8%）在 9 个月大时 HBsAg 阳性；在 23 名仅接种了出生剂量疫苗的婴儿中，有 2 人（8.7%）在 9 个月大时 HBsAg 阳性；而在 33 名既未接种疫苗也未接种 HBIg 的婴儿中，有 8 人（24.2%）在出生时 HBsAg 阳性（P = 0.002）。高母体病毒载量（>200,000 IU/ml；调整赔率比 [AOR] 10.4；95 % 置信区间 [CI]1.2-92.1）和未接种 HBV 出生剂量疫苗或 HBIg（AOR 29.2；95 % CI 4.0-211.3）是母婴传播的独立预测因素：在埃塞俄比亚，接种或不接种HBIg的出生剂量HBV疫苗可显著降低HBV母婴传播的风险。当务之急是提高出生剂量 HBV 疫苗的覆盖率。

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A prospective, multicenter study of hepatitis B birth-dose vaccine with or without hepatitis B immunoglobulin in preventing mother-to-child transmission of hepatitis B virus in Ethiopia

Background

Historically, mother-to-child transmission (MTCT) of hepatitis B virus (HBV) was considered uncommon in Africa, leading to a reluctant attitude to birth-dose HBV vaccination on the continent. As a randomized trial would be unethical, real-life data are needed to assess the effect of HBV birth-dose vaccine in Africa.

Methods

A multicenter, prospective, observational study of hepatitis B surface antigen (HBsAg)-positive pregnant women and their infants was carried out in Ethiopia, from January 2019 to May 2021. Pregnant women were screened for HBsAg and HIV as part of routine antenatal care and/or delivery, and HBsAg-positive HIV-negative pregnant women were included in the study. HBV birth-dose vaccine and hepatitis B immunoglobulin (HBIg) were recommended but not all newborns received it as it was not national policy. All infants, however, received the pentavalent HBV vaccine at 6, 10, and 14 weeks of age. Vaccination status was confirmed from delivery ward charts and infant vaccination certificates. Infants were tested for HBsAg at 9 months of age and a positive result was taken as evidence of MTCT.

Findings

Of 290 HBsAg-positive pregnant women, 168 mother/infant pairs returned for their 9-month follow-up visit and were included in this analysis. Two of 112 (1.8 %) infants who received birth-dose vaccine with HBIg, and 2 of 23 (8.7 %) who received birth-dose vaccine alone were HBsAg positive at nine months of age, compared to 8 of 33 (24.2 %) who received neither vaccine nor HBIg at birth (p = 0.002). High maternal viral load (>200,000 IU/ml; adjusted odds ratio [AOR] 10.4; 95 % confidence interval [CI] 1.2–92.1) and not receiving HBV birth-dose vaccine nor HBIg (AOR 29.2; 95 % CI 4.0–211.3) were independent predictors of MTCT.

Interpretation

Birth-dose HBV vaccine with or without HBIg significantly reduced the risk of MTCT of HBV in Ethiopia. Improved coverage of birth-dose HBV vaccine should be an urgent priority.

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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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