Timing of Vaccination With the Non-live DTaP-IPV-Hib Vaccine and Development of Atopic Dermatitis Before 1 Year of Age - a Danish Register Based Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,027,559
- 主要终点
- Atopic dermatitis (AD)
研究概览
简要总结
It has been found that the non-live vaccine against Diphtheria, Tetanus, and Pertussis (DTP) in addition to its disease specific effects may have so called "non-specific effects" with the potential to affect sensitivity towards vaccine unrelated pathogens, resulting in excess mortality(Aaby, Kollmann, & Benn, 2014).
A recent study from Australia found that delayed vaccination with the first dose of Diphtheria, Tetanus, and acellular Pertussis(DTaP)-containing vaccine is associated with reduced risk of atopic dermatitis (aOR: 0.57; 95% CI: 0.34-0.97, P = 0.04) and reduced use of medication against atopic dermatitis (aOR: 0.45; 95% CI: 0.24-0.83, P = 0.01)(Kiraly et al., 2016).
This register based observational study aims to extend the existing knowledge on non-specific effects of non-live vaccines by testing the above finding, that delayed vaccination with Diphtheria, Tetanus, acellular Pertussis - Inactivated Polio vaccine - Haemophilus influenzae type b (DTaP-IPV-Hib) is associated with lower risk of developing atopic dermatitis before 1 year of age in the Danish birth cohorts from 1997-2012.
详细描述
It has been found that the non-live vaccine against Diphtheria, Tetanus, and Pertussis (DTP) in addition to its disease specific effects may have so called non-specific effects with the potential to affect resistance towards vaccine unrelated pathogens, resulting in excess mortality and morbidity(Aaby et al., 2014). These immunomodifying effects may affect development of atopic dermatitis through increased immunological sensitivity(Nilsson, Gruber, Granstrom, Bjorksten, & Kjellman, 1998). A recent study from Australia found that delayed vaccination with the first dose of Diphtheria, Tetanus, and acellular Pertussis(DTaP)-containing vaccine is associated with reduced eczema (aOR: 0.57; 95% CI: 0.34-0.97, P = 0.04) and reduced use of medication against atopic dermatitis (aOR: 0.45; 95% CI: 0.24-0.83, P = 0.01)(Kiraly et al., 2016). The present study aims to test the above finding and investigate the effect of timeliness of vaccination with DTaP-IPV-Hib (with or without PCV) on development of atopic dermatitis before 1 year of age among Danish children born between 1997 and 2012. From 1997 to 2012 children in Denmark were scheduled to receive the 1st, 2nd, and 3rd dose of DTaP-IPV-Hib at 3, 5, and 12 months respectively.
Primary investigation:
Research question 1.a Is delayed vaccination with the first dose of DTaP-IPV-Hib (vaccination at or after 4 months of age) associated with a reduced risk of development of atopic dermatitis from 4 months and until but not including 12 months of age compared with receiving the first dose of DTaP-IPV-Hib before 4 months of age?
Secondary investigations:
Research question 1.b Among children with a timely 1st dose of DTaP-IPV-Hib (vaccination before 4 months of age), is delayed vaccination with the second dose of DTaP-IPV-Hib (vaccination at or after 6 months of age) associated with a reduced risk of development of atopic dermatitis from 6 months and until but not including 12 months of age compared with receiving the second dose of DTaP-IPV-Hib before 6 months of age?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 24 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born in Denmark between between 1 January 1997 - 31 December 2012
排除标准
- •Do not receive 1st dose of DTaP-IPV-Hib before 1 year of age
- •Died before 24 months of age
- •Migrate before 24 months of age
- •Receive any vaccines other than DTaP-IPV-Hib, with or without PCV before 12 months of age
- •Develop Atopic Dermatitis prior to baseline
- •Have missing confounder information
结局指标
主要结局
Atopic dermatitis (AD)
时间窗: RQ1.a+ 1.b: Registered AD from baseline until 12 months of age. RQ2: AD is assessed from baseline (3 months of age) through follow-up (until 8 months of age)
Atopic dermatitis (AD) is categorized according to an algorithm derived and developed from a recent Danish study on the incidence of atopic diseases in Denmark and Sweden (Henriksen et al., 2015). The algorithm uses register information to identify AD including ICD- diagnostic codes from the Danish National Patient Registry(DNPR)(Lynge, Sandegaard, \& Rebolj, 2011) and Anatomical Therapeutic Chemical classification codes(ATC) from the Danish National Prescription Register(Kildemoes, Sorensen, \& Hallas, 2011)
次要结局
- Receipt of medication for atopic dermatitis (only for the primary investigation 1.a)(Receipt of medication for atopic dermatitis from baseline until end of follow-up is assessed at 12 months of age.)