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Immunogenicity of an oral rotavirus vaccine administered with prenatal nutritional support in Niger: A cluster randomized clinical trial.
PLOS Medicine ( IF 15.8 ) Pub Date : 2021-08-10 , DOI: 10.1371/journal.pmed.1003720
Sheila Isanaka 1, 2 , Souna Garba 3 , Brian Plikaytis 4 , Monica Malone McNeal 5 , Ousmane Guindo 3 , Céline Langendorf 1 , Eric Adehossi 6 , Iza Ciglenecki 7 , Rebecca F Grais 1
Affiliation  

BACKGROUND Nutritional status may play a role in infant immune development. To identify potential boosters of immunogenicity in low-income countries where oral vaccine efficacy is low, we tested the effect of prenatal nutritional supplementation on immune response to 3 doses of a live oral rotavirus vaccine. METHODS AND FINDINGS We nested a cluster randomized trial within a double-blind, placebo-controlled randomized efficacy trial to assess the effect of 3 prenatal nutritional supplements (lipid-based nutrient supplement [LNS], multiple micronutrient supplement [MMS], or iron-folic acid [IFA]) on infant immune response (n = 53 villages and 1,525 infants with valid serology results: 794 in the vaccine group and 731 in the placebo group). From September 2015 to February 2017, participating women received prenatal nutrient supplement during pregnancy. Eligible infants were then randomized to receive 3 doses of an oral rotavirus vaccine or placebo at 6-8 weeks of age (mean age: 6.3 weeks, 50% female). Infant sera (pre-Dose 1 and 28 days post-Dose 3) were analyzed for anti-rotavirus immunoglobulin A (IgA) using enzyme-linked immunosorbent assay (ELISA). The primary immunogenicity end point, seroconversion defined as ≥3-fold increase in IgA, was compared in vaccinated infants among the 3 supplement groups and between vaccine/placebo groups using mixed model analysis of variance procedures. Seroconversion did not differ by supplementation group (41.1% (94/229) with LNS vs. 39.1% (102/261) with multiple micronutrients (MMN) vs. 38.8% (118/304) with IFA, p = 0.91). Overall, 39.6% (n = 314/794) of infants who received vaccine seroconverted, compared to 29.0% (n = 212/731) of infants who received placebo (relative risk [RR]: 1.36; 95% confidence interval [CI]: 1.18, 1.57, p < 0.001). This study was conducted in a high rotavirus transmission setting. Study limitations include the absence of an immune correlate of protection for rotavirus vaccines, with the implications of using serum anti-rotavirus IgA for the assessment of immunogenicity and efficacy in low-income countries unclear. CONCLUSIONS This study showed no effect of the type of prenatal nutrient supplementation on immune response in this setting. Immune response varied depending on previous exposure to rotavirus, suggesting that alternative delivery modalities and schedules may be considered to improve vaccine performance in high transmission settings. TRIAL REGISTRATION ClinicalTrials.gov NCT02145000.

中文翻译:

在尼日尔进行产前营养支持的口服轮状病毒疫苗的免疫原性:一项集群随机临床试验。

背景营养状况可能在婴儿免疫发育中起作用。为了在口服疫苗效力低的低收入国家识别潜在的免疫原性增强剂,我们测试了产前营养补充对 3 剂口服轮状病毒活疫苗的免疫反应的影响。方法和发现 我们在一项双盲、安慰剂对照的随机疗效试验中嵌套了一项整群随机试验,以评估 3 种产前营养补充剂(基于脂质的营养补充剂 [LNS]、多种微量营养素补充剂 [MMS] 或铁-叶酸 [IFA])对婴儿免疫反应的影响(n = 53 个村庄和 1,525 名具有有效血清学结果的婴儿:疫苗组 794 名,安慰剂组 731 名)。2015年9月至2017年2月,参与的妇女在怀孕期间接受了产前营养补充剂。然后,符合条件的婴儿在 6-8 周龄时随机接受 3 剂口服轮状病毒疫苗或安慰剂(平均年龄:6.3 周,50% 为女性)。使用酶联免疫吸附测定 (ELISA) 分析婴儿血清(给药前 1 天和给药 3 后 28 天)的抗轮状病毒免疫球蛋白 A(IgA)。主要免疫原性终点,血清转化定义为 IgA 增加 ≥ 3 倍,使用方差混合模型分析程序在 3 个补充剂组和疫苗/安慰剂组之间的疫苗接种婴儿中进行比较。不同补充剂组的血清转化率没有差异(LNS 为 41.1% (94/229),多种微量营养素 (MMN) 为 39.1% (102/261),IFA 为 38.8% (118/304),p = 0.91)。总的来说,39。6% (n = 314/794) 接受疫苗的婴儿出现血清转化,而接受安慰剂的婴儿为 29.0% (n = 212/731)(相对风险 [RR]:1.36;95% 置信区间 [CI]:1.18) , 1.57, p < 0.001)。本研究是在轮状病毒高传播环境中进行的。研究局限性包括轮状病毒疫苗缺乏免疫相关保护,在低收入国家使用血清抗轮状病毒 IgA 评估免疫原性和功效的意义尚不清楚。结论 本研究表明,在这种情况下,产前营养补充类型对免疫反应没有影响。免疫反应因先前接触轮状病毒而异,这表明可以考虑替代递送方式和时间表来提高高传播环境中的疫苗性能。
更新日期:2021-08-10
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