两项基于社区的随机试验设计，旨在评估尼泊尔农村地区孕妇流感免疫接种对孕妇及其婴儿呼吸道疾病的影响以及生殖结局。
Designs of two randomized, community-based trials to assess the impact of influenza immunization during pregnancy on respiratory illness among pregnant women and their infants and reproductive outcomes in rural Nepal.
作者信息
Tielsch James M, Steinhoff Mark, Katz Joanne, Englund Janet A, Kuypers Jane, Khatry Subarna K, Shrestha Laxman, LeClerq Steven C
机构信息
Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.
Global Health Center, Cincinnati Children's Medical Center, Cincinnati, OH, USA.
出版信息
BMC Pregnancy Childbirth. 2015 Feb 20;15:40. doi: 10.1186/s12884-015-0470-y.
BACKGROUND
Among the most important causes of illness and death in both pregnant women and their newborn infants are respiratory infections including influenza. Pregnant women in North America have a 4 to 5 fold excess rate of hospitalization compared to non-pregnant women. Rates of infant hospitalization associated with influenza are much higher than in their mothers. Fully half of children hospitalized for influenza in the US are in the age group 0-5 months, a group where no vaccine is licensed. Data on influenza are much fewer in low income countries where the risks of serious morbidity and mortality are much higher. A recent trial in Bangladesh suggested that influenza immunization in pregnant women could have important protective effects against influenza in both mothers and their infants. These trials were designed to provide additional evidence about the effect of influenza vaccination in pregnancy in settings where influenza may circulate for up to ten months/year.
METHODS/DESIGN: We conducted a consecutive pair of community-based, placebo-controlled, randomized trials of influenza vaccination of pregnant women in a rural district in southern Nepal. Two trials were conducted to insure, as much as possible, the match of circulating strains with those included in the vaccine. Eligible women included all who were or became pregnant over a one year period. Each trial included a one year cohort of pregnant women who were individually randomized to the influenza vaccine available at the time of their enrollment or placebo. Exclusions included a history of allergy to vaccine components, prior influenza vaccine receipt, and for the second trial, participation in the first trial. Morbidity was assessed on a weekly basis for women throughout pregnancy and through 180 days post-partum. Infants were followed weekly through 180 days. Primary outcomes included: 1) incidence of influenza like illness in women, 2) incidence of laboratory confirmed influenza illness in infants, and 3) birthweight among newborn infants.
DISCUSSION
We have presented the design and methods of two randomized trials of influenza immunization of pregnant women.
TRIAL REGISTRATION
Clinicaltrials.gov: ( NCT01034254 ).
背景
在孕妇及其新生儿患病和死亡的最重要原因中，包括流感在内的呼吸道感染位列其中。与非孕妇相比，北美的孕妇住院率高出4至5倍。与流感相关的婴儿住院率远高于其母亲。在美国，因流感住院的儿童中有整整一半属于0至5个月龄组，这是一个尚无获批疫苗的年龄组。在严重发病和死亡风险高得多的低收入国家，有关流感的数据要少得多。孟加拉国最近的一项试验表明，孕妇接种流感疫苗可能对母亲及其婴儿预防流感具有重要的保护作用。这些试验旨在为在流感可能每年传播长达10个月的环境中孕期接种流感疫苗的效果提供更多证据。
方法/设计：我们在尼泊尔南部的一个农村地区对孕妇进行了连续两项基于社区的、安慰剂对照的流感疫苗接种随机试验。进行了两项试验以尽可能确保流行毒株与疫苗中所含毒株相匹配。符合条件的妇女包括在一年期间内怀孕或已怀孕的所有妇女。每项试验都纳入了一组为期一年的孕妇，她们被单独随机分配接受入组时可用的流感疫苗或安慰剂。排除标准包括对疫苗成分过敏史、先前接种过流感疫苗，以及在第二项试验中曾参与第一项试验。在整个孕期及产后180天，每周对妇女的发病率进行评估。对婴儿每周随访至180天。主要结局包括：1）妇女中流感样疾病的发病率，2）婴儿中实验室确诊的流感疾病的发病率，以及3）新生儿的出生体重。
讨论
我们介绍了两项孕妇流感免疫随机试验的设计和方法。
试验注册
Clinicaltrials.gov：（NCT01034254）
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