Biosecurity Program, Kirby Institute, Faculty of Medicine, University of New South Wales, Kensington, NSW 2052, Australia.
BMT Services, Children's Hospital at Westmead, Hawkesbury Rd, Westmead, NSW 2145, Australia.
Vaccine. 2019 Sep 3;37(37):5630-5636. doi: 10.1016/j.vaccine.2019.07.072. Epub 2019 Aug 8.
Human Papillomavirus (HPV) causes significant burden of HPV-related diseases, which are more prevalent in immunosuppressed compared to immunocompetent people. We conducted a multi-centre clinical trial to determine the immunogenicity and reactogenicity of HPV vaccine in immunocompromised children. Here we present the immunogenicity results 5 years post vaccination.
We followed up immunocompromised children (5-18 years) with a range of specified underlying conditions who were previously recruited from three Australian paediatric hospitals. Participants received three doses of quadrivalent HPV vaccine (Gardasil Quadrivalent HPV Types 6, 11, 16, 18) and were followed up between 2007 and 2016 (60 months post-vaccination). The immunogenicity primary outcome was seroconversion and geometric mean titres (GMT) of the quadrivalent HPV vaccine serotypes in the study.
Of the 59 original participants, 37 were followed up at 60 months. The proportion of participants who seroconverted were: 86.5%, 89.2%, 89.2%, 91.9% by competitive Luminex immunoassay (cLIA) and 83.8%, 83.8%, 94.6%, 78.4% by total immunoglobulin G assays (IgG) for serotypes 6, 11, 16 and 18 respectively. GMT values ranged from 118 (95%CI: 79-177) for serotype 11, to 373 (95%CI: 215-649) for serotype 16 by cLIA. For IgG, serotype 16 had the highest GMT of 261 (95%CI: 143-477) and serotype 18 had the lowest value of 37 (95%CI: 21-68). All antibody titres were lower in females compared to males but the difference was not statistically significant except for serotype 16. No serious adverse event was reported during this follow-up period.
Our evidence, although limited by small numbers, is reassuring that a three dose schedule of HPV vaccine remains immunogenic in immunocompromised children to five years post vaccination. Large scale studies are required to determine long term protection in immunocompromised children.
NCT02263703 (ClinicalTrials.gov).
人乳头瘤病毒（HPV）会导致与 HPV 相关的疾病，这些疾病在免疫抑制人群中比免疫功能正常人群更为普遍。我们进行了一项多中心临床试验，以确定 HPV 疫苗在免疫抑制儿童中的免疫原性和反应原性。在此，我们报告接种疫苗后 5 年的免疫原性结果。
我们随访了先前从澳大利亚三家儿科医院招募的患有各种特定基础疾病的免疫抑制儿童（5-18 岁）。参与者接受了三剂四价 HPV 疫苗（佳达修四价 HPV 型 6、11、16、18），并在 2007 年至 2016 年期间进行了随访（接种疫苗后 60 个月）。免疫原性主要结局是研究中四价 HPV 疫苗血清型的血清转化率和几何平均滴度（GMT）。
在最初的 59 名参与者中，有 37 名在 60 个月时进行了随访。血清转化率分别为：86.5%、89.2%、89.2%、91.9%，采用竞争 Luminex 免疫测定法（cLIA）；83.8%、83.8%、94.6%、78.4%，采用总免疫球蛋白 G 测定法（IgG），血清型 6、11、16 和 18。cLIA 法检测的血清型 11 的 GMT 值范围为 118（95%CI：79-177），血清型 16 的 GMT 值范围为 373（95%CI：215-649）。对于 IgG，血清型 16 的 GMT 值最高，为 261（95%CI：143-477），血清型 18 的 GMT 值最低，为 37（95%CI：21-68）。与男性相比，女性的所有抗体滴度均较低，但除血清型 16 外，差异无统计学意义。在本随访期间未报告严重不良事件。
尽管我们的证据数量有限，但仍令人放心的是，在免疫抑制儿童中，HPV 疫苗三剂方案在接种疫苗后五年仍具有免疫原性。需要进行大规模研究以确定免疫抑制儿童的长期保护作用。
NCT02263703（ClinicalTrials.gov）。
