孕妇流感疫苗接种及其对婴儿的保护。

Influenza vaccination of pregnant women and protection of their infants.

机构信息

From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit (S.A.M., C.L.C., L.K., A.H., S.J., P.V.A., N.N., K.P.K., M.C.N.), the Department of Science and Technology-National Research Foundation, Vaccine-Preventable Diseases (S.A.M., C.L.C., L.K., A.H., S.J., P.V.A., N.N., M.C.N.), and the Perinatal HIV Research Unit (A.V.), University of the Witwatersrand, the National Institute for Communicable Diseases, the National Health Laboratory Service, Centre for Vaccines and Immunology (S.A.M., F.T., M.V.), Johannesburg, and the Department of Medical Virology, University of Pretoria, Pretoria (M.V.) - all in South Africa; the School of Medicine and Children's Hospital, University of Colorado (A.W.), the Department of Pediatrics, Medicine and Pathology, University of Colorado School of Medicine (E.A.F.S.), and the Center for Global Health, Department of Epidemiology, Colorado School of Public Health (E.A.F.S.) - all in Aurora, Colorado; the Department of Medicine and Department of Global Health, University of Washington (J.R.O.), and the Vaccine Access and Delivery Global Program, PATH (J.R.O., K.M.N.) - both in Seattle; and the Hubert Department of Global Health, Rollins School of Public Health, and the Division of Infectious Diseases, School of Medicine, Emory University, Atlanta (K.P.K.).

出版信息

N Engl J Med. 2014 Sep 4;371(10):918-31. doi: 10.1056/NEJMoa1401480.

DOI:10.1056/NEJMoa1401480

PMID:25184864

Abstract

BACKGROUND

There are limited data on the efficacy of vaccination against confirmed influenza in pregnant women with and those without human immunodeficiency virus (HIV) infection and protection of their infants.

METHODS

We conducted two double-blind, randomized, placebo-controlled trials of trivalent inactivated influenza vaccine (IIV3) in South Africa during 2011 in pregnant women infected with HIV and during 2011 and 2012 in pregnant women who were not infected. The immunogenicity, safety, and efficacy of IIV3 in pregnant women and their infants were evaluated until 24 weeks after birth. Immune responses were measured with a hemagglutination inhibition (HAI) assay, and influenza was diagnosed by means of reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assays of respiratory samples.

RESULTS

The study cohorts included 2116 pregnant women who were not infected with HIV and 194 pregnant women who were infected with HIV. At 1 month after vaccination, seroconversion rates and the proportion of participants with HAI titers of 1:40 or more were higher among IIV3 recipients than among placebo recipients in both cohorts. Newborns of IIV3 recipients also had higher HAI titers than newborns of placebo recipients. The attack rate for RT-PCR-confirmed influenza among both HIV-uninfected placebo recipients and their infants was 3.6%. The attack rates among HIV-uninfected IIV3 recipients and their infants were 1.8% and 1.9%, respectively, and the respective vaccine-efficacy rates were 50.4% (95% confidence interval [CI], 14.5 to 71.2) and 48.8% (95% CI, 11.6 to 70.4). Among HIV-infected women, the attack rate for placebo recipients was 17.0% and the rate for IIV3 recipients was 7.0%; the vaccine-efficacy rate for these IIV3 recipients was 57.7% (95% CI, 0.2 to 82.1).

CONCLUSIONS

Influenza vaccine was immunogenic in HIV-uninfected and HIV-infected pregnant women and provided partial protection against confirmed influenza in both groups of women and in infants who were not exposed to HIV. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov numbers, NCT01306669 and NCT01306682.).

摘要

背景

关于接种流感疫苗对感染和未感染人类免疫缺陷病毒（HIV）的孕妇及其婴儿的有效性和保护作用的数据有限。

方法

我们在南非开展了两项关于三价灭活流感疫苗（IIV3）的双盲、随机、安慰剂对照试验，一项在 2011 年进行，研究对象为感染 HIV 的孕妇，另一项在 2011 年和 2012 年进行，研究对象为未感染 HIV 的孕妇。评估了 IIV3 对孕妇及其婴儿的免疫原性、安全性和疗效，直至婴儿出生后 24 周。采用血凝抑制（HAI）试验检测免疫反应，采用逆转录-聚合酶链反应（RT-PCR）检测呼吸道样本诊断流感。

结果

研究队列包括 2116 名未感染 HIV 的孕妇和 194 名感染 HIV 的孕妇。接种后 1 个月，IIV3 组的血清转化率和 HAI 滴度≥1:40 的参与者比例均高于安慰剂组。IIV3 组新生儿的 HAI 滴度也高于安慰剂组新生儿。未感染 HIV 的安慰剂组孕妇及其婴儿的 RT-PCR 确诊流感发病率为 3.6%。未感染 HIV 的 IIV3 组孕妇及其婴儿的发病率分别为 1.8%和 1.9%，相应的疫苗有效率分别为 50.4%（95%可信区间[CI]，14.5 至 71.2）和 48.8%（95%CI，11.6 至 70.4）。在感染 HIV 的妇女中，安慰剂组的发病率为 17.0%，IIV3 组的发病率为 7.0%；这些 IIV3 组的疫苗有效率为 57.7%（95%CI，0.2 至 82.1）。