National Allergy Research Centre, Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Hellerup, Denmark.
Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.
Contact Dermatitis. 2022 Nov;87(5):430-438. doi: 10.1111/cod.14180. Epub 2022 Jul 19.
BACKGROUND: Aluminium-adsorbed vaccines may in some children cause severely itching nodules at the injection site, known as vaccination granulomas. OBJECTIVE: To investigate vaccine-, child- and maternal-level risk factors for the development of vaccination granulomas following immunization with aluminium-adsorbed vaccines. METHODS: A Danish population-based cohort study with 553 932 children born in Denmark from 1 January 2009 to 31 December 2018, vaccinated with an aluminium-adsorbed vaccine during the first year of life, followed until 31 December 2020. Poisson regression was used to estimate granuloma rate ratios according to the type of adjuvant, accumulated dose of aluminium, timing of vaccination appointments, sex, gestational age, having siblings with granulomas, maternal age and maternal ethnicity. RESULTS: We identified 1901 vaccination granuloma cases (absolute risk, 0.34%). Among vaccine level factors, revaccination (third vs. first vaccination appointment, adjusted rate ratio [RR] 1.26, 95% confidence interval [CI] 1.03-1.55), the specific adjuvant used (aluminium phosphate vs. hydroxide, RR 0.58, 95% CI 0.48-0.70) and dosage (≥1.0 mg vs. <1.0 mg, RR 1.34, 95% CI 1.19-1.52) were associated with risk of granulomas; the timing of vaccination appointments was not. Among child-level factors, female sex (vs. males, RR 1.12, 95% CI, 1.02-1.22), prematurity (vs. term birth, RR 0.71, 95% CI, 0.54-0.93) and having sibling(s) with granulomas (vs. no siblings with granulomas, RR 46.15, 95% CI, 33.67-63.26) were associated with risk of granulomas. Among maternal-level factors, non-Danish ethnicity (vs. Danish, RR 0.51, 95% CI, 0.42-0.63) and young maternal age (<20 years vs. 20-39 years, RR 0.46, 95% CI 0.25-0.83) were associated with risk of granulomas. CONCLUSIONS: Several risk factors for vaccination granulomas at the vaccine, child and maternal levels, were identified. Reducing the dose of aluminium or replacing aluminium hydroxide with aluminium phosphate could reduce the risk of granulomas. However, this must be balanced against the potential for reduced immunogenicity.
背景：含铝佐剂疫苗在某些儿童中可能会在注射部位引起严重瘙痒结节，称为疫苗肉芽肿。
目的：研究接种含铝疫苗后疫苗、儿童和产妇水平的危险因素与接种后发生疫苗肉芽肿的关系。
方法：这是一项丹麦基于人群的队列研究，纳入了 2009 年 1 月 1 日至 2018 年 12 月 31 日期间在丹麦出生的 553932 名儿童，他们在生命的第一年接受了含铝疫苗接种，并随访至 2020 年 12 月 31 日。采用泊松回归估计根据佐剂类型、铝累积剂量、接种预约时间、性别、胎龄、是否有兄弟姐妹患有肉芽肿、产妇年龄和产妇种族的肉芽肿发生率比。
结果：共发现 1901 例疫苗肉芽肿病例（绝对风险，0.34%）。在疫苗水平的因素中，复种（第 3 次 vs. 第 1 次接种预约，调整后的发生率比 [RR] 1.26，95%置信区间 [CI] 1.03-1.55）、具体佐剂的使用（磷酸铝 vs. 氢氧化物，RR 0.58，95%CI 0.48-0.70）和剂量（≥1.0mg vs. <1.0mg，RR 1.34，95%CI 1.19-1.52）与肉芽肿风险相关；接种预约时间无相关性。在儿童水平的因素中，女性（vs. 男性，RR 1.12，95%CI，1.02-1.22）、早产（vs. 足月出生，RR 0.71，95%CI，0.54-0.93）和有兄弟姐妹患有肉芽肿（vs. 没有兄弟姐妹患有肉芽肿，RR 46.15，95%CI，33.67-63.26）与肉芽肿风险相关。在产妇水平的因素中，非丹麦族裔（vs. 丹麦族裔，RR 0.51，95%CI，0.42-0.63）和产妇年龄较小（<20 岁 vs. 20-39 岁，RR 0.46，95%CI 0.25-0.83）与肉芽肿风险相关。
结论：确定了疫苗、儿童和产妇水平的几种疫苗肉芽肿危险因素。减少铝的剂量或用磷酸铝替代氢氧化物可能会降低肉芽肿的风险。然而，这必须与潜在的免疫原性降低相平衡。
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