Vittrup Dorthe Maria, Jensen Andreas, Sørensen Jesper Kiehn, Zimakoff Anne Cathrine, Malon Michelle, Charabi Salma, Johansen Marie Ryberg, Simões Eric A F, Kirkby Nikolai Søren, Buus Søren, Svensson Jannet, Stensballe Lone Graff
The Child and Adolescent Department, The University Hospital Herlev, Denmark.
The Child and Adolescent Clinic, The Juliane Marie Centre, The Danish National University Hospital "Rigshospitalet", Denmark.
EClinicalMedicine. 2024 Jan 12;68:102421. doi: 10.1016/j.eclinm.2023.102421. eCollection 2024 Feb.
Measles is a highly contagious viral disease. Vaccinated mothers transfer fewer antibodies during pregnancy, resulting in shortened infant immunity. Earlier primary vaccination might avert the gap in protection.
Healthy 5-7-month-old Danish infants were assigned in a 1:1 ratio to M-M-RVaxPro or placebo (solvent) in a double-blind, randomized trial between April 15, 2019 and November 1, 2021 (ClinicalTrials.govNCT03780179, EudraCT 2016-001901-18). Eligibility criteria were birth weight >1000 g and gestational age ≥32 weeks.Immunogenicity was measured by plaque reduction neutralization test (PRNT) and IgG ELISA before intervention, four weeks after intervention and routine MMR. Reactogenicity data were collected for six weeks and measured by hazard ratios (HR).
647 and 6540 infants participated in the immunogenicity and reactogenicity study, respectively; 87% and 99% completed follow-up. After early MMR, seroprotection rates (SPRs) were 47% (13%) in measles PRNT; 28% (2%), 57% (8%) in mumps and rubella IgG (placebo). For measles PRNT, geometric mean ratio was 4.3 (95% CI: 3.4-5.3) between randomization groups after intervention and 1.5 (95% CI: 1.3-1.9) after routine MMR.Reactogenicity was independent of randomization (HR, 1.0; 95% CI: 0.9-1.1). Severe adverse events occurred in 25 infants (HR, 1.8; 95% CI: 0.8-4.0); none deemed vaccine related.
Early MMR elicited low SPRs but did not negatively impact short-term responses to a subsequent MMR. MMR at 5-7 months was safe and not associated with higher rates of reactogenicity than placebo.
Innovation Fund Denmark.
麻疹是一种高度传染性的病毒性疾病。接种过疫苗的母亲在孕期传递的抗体较少，导致婴儿免疫力缩短。更早进行初次疫苗接种可能避免保护方面的差距。
在2019年4月15日至2021年11月1日期间，将健康的5至7个月大丹麦婴儿按1:1比例分配至M-M-RVaxPro或安慰剂（溶剂）组，进行双盲随机试验（ClinicalTrials.govNCT03780179，EudraCT 2016-001901-18）。入选标准为出生体重>1000克且胎龄≥32周。在干预前、干预后四周和常规麻疹、腮腺炎、风疹联合疫苗（MMR）接种后，通过蚀斑减少中和试验（PRNT）和IgG酶联免疫吸附测定（ELISA）测量免疫原性。收集六周的反应原性数据，并通过风险比（HR）进行测量。
分别有647名和6540名婴儿参与免疫原性和反应原性研究；87%和99%完成随访。早期MMR接种后，麻疹PRNT中的血清保护率（SPR）为47%（13%）；腮腺炎和风疹IgG（安慰剂）中的SPR分别为28%（2%）、57%（8%）。对于麻疹PRNT，干预后随机分组之间的几何平均比为4.3（95%置信区间：3.4-5.3），常规MMR接种后为1.5（95%置信区间：1.3-1.9）。反应原性与随机分组无关（HR，1.0；95%置信区间：0.9-1.1）。25名婴儿发生严重不良事件（HR，1.8；95%置信区间：0.8-4.0）；均认为与疫苗无关。
早期MMR接种引发的SPR较低，但对随后MMR的短期反应没有负面影响。5至7个月时接种MMR是安全的，且与比安慰剂更高的反应原性发生率无关。
丹麦创新基金。
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