Nutritional status of infants at six months of age following maternal influenza immunization: A randomized placebo-controlled trial in rural Nepal.

Nutritional status of infants at six months of age following maternal influenza immunization: A randomized placebo-controlled trial in rural Nepal.
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DOI:
10.1016/j.vaccine.2017.09.095
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发表时间:
2017-12-04
期刊:
影响因子:
5.5
通讯作者:
Tielsch JM
Tielsch JM
中科院分区:
医学3区
文献类型:
--
作者:
Katz J;Englund JA;Steinhoff MC;Khatry SK;Shrestha L;Kuypers J;Mullany LC;Chu HY;LeClerq SC;Kozuki N;Tielsch JM

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在随机分为疫苗组或安慰剂组的2个年度队列中,母亲接种流感疫苗可使低出生体重降低15%。在6个月大的婴儿中,治疗组的发育迟缓没有差异。在队列2中,疫苗与流行病毒匹配较好,消瘦患病率较低。与安慰剂相比,接种疫苗组的严重消瘦和发育迟缓发生率较低。在南亚的两项随机试验中,母亲接种流感疫苗增加了出生体重,但对婴儿生长的影响尚不清楚。2011年4月至2014年4月,在尼泊尔南部平原Sarlahi地区的两个年度队列中进行了一项全年孕产妇流感免疫的随机安慰剂对照试验。参加试验的妇女所生的婴儿在出生和6个月大时测量了体重、身长和头围。这项研究是为3个主要试验结果提供动力的,但没有为6个月大时的发育迟缓和消瘦提供动力。3693名妇女在妊娠17至34周期间接种了安慰剂或流感疫苗,导致3646名活产婴儿。在存活下来的婴儿中,约72%的婴儿在150至210天之间进行了体重和身高测量。在安慰剂组和疫苗组中,发育迟缓(< - 2 Z评分长度年龄比)的患病率分别为14.8%和13.6%。安慰剂组和疫苗组的发育迟缓< - 3z评分分别为3.2%和2.0% (RR: 0.64 (95% CI: 0.39, 1.04))。在安慰剂组和疫苗组中,消瘦(< - 2 Z评分体重比长度)为10.3%和11.0%。安慰剂组的严重消瘦(< - 3 Z评分体重长度)为3.8%,而疫苗组为2.6% (RR: 0.69 (95% CI: 0.44, 1.07))。流感疫苗对消瘦的影响在队列2中比在队列1中更大(任何消瘦的RR: 0.66(0.44, 0.99)),严重消瘦的RR: 0.45(0.19, 1.09)。在队列2中,这对应于对出生体重的更大影响和与循环病毒更好的疫苗匹配。虽然母亲免疫使低出生体重降低了15%,但在第二队列中,只有6个月时的消瘦具有统计学意义。然而,这项研究在检测公共卫生重要性的降低方面能力不足。试验注册:Clinicaltrials.gov (NCT01034254)。
Maternal influenza vaccination reduced low birthweight by 15% in 2 annual cohorts randomized to vaccine or placebo. There was no difference in stunting among infants 6 months of age by treatment group. Wasting prevalence was lower in cohort 2 where vaccine matched circulating virus better. Severe wasting and stunting was lower in the vaccine group compared to placebo. Maternal influenza vaccination has increased birth weight in two randomized trials in South Asia but the impact on infant growth is unknown. A randomized placebo-controlled trial of year round maternal influenza immunization was conducted in two annual cohorts in Sarlahi District, southern plains of Nepal, from April 2011 through April 2014. Infants born to women enrolled in the trial had weight, length, and head circumference measured at birth and 6 months of age. The study was powered for the 3 primary trial outcomes but not for stunting and wasting at 6 months of age. 3693 women received placebo or influenza vaccine between 17 and 34 weeks gestation, resulting in 3646 live births. About 72% of infants who survived had weight and length measurements between 150 and 210 days of age. Prevalence of stunting (<−2 Z scores length-for-age) was 14.8% in the placebo and 13.6% in the vaccine groups, respectively. Stunting < −3 Z scores was 3.2% versus 2.0% in placebo versus vaccine groups (RR: 0.64 (95% CI: 0.39, 1.04)). Wasting (< −2 Z scores weight for length) was 10.3% versus 11.0% for placebo versus vaccine groups. Severe wasting (< −3 Z scores weight for length) was 3.8% for placebo versus 2.6% for vaccine (RR: 0.69 (95% CI: 0.44, 1.07)). The impact of flu vaccine on wasting was greater in cohort 2 than in cohort 1, (RR: 0.66 (0.44, 0.99) for any wasting), and RR: 0.45 (0.19, 1.09) for severe wasting. This corresponded to a larger impact on birth weight and a better vaccine match with circulating viruses in cohort 2. Although maternal immunization reduced low birth weight by 15%, only wasting at 6 months in the 2nd cohort was statistically significantly difference. However, the study was underpowered to detect reductions of public health importance. Trial Registration: Clinicaltrials.gov (NCT01034254).
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