Virtanen M, Peltola H, Paunio M, Heinonen O P
National Research and Development Center for Welfare and Health, Hospital for Children and Adolescents, Helsinki, Finland.
Pediatrics. 2000 Nov;106(5):E62. doi: 10.1542/peds.106.5.e62.
Revaccination policies adopted in many countries to control measles have raised various safety issues including those concerning the second vaccine dose. We performed a prospective, double-blind, crossover trial among twins receiving a measles-mumps-rubella (MMR) vaccine.
The study comprised 1162 monozygous and heterozygous twins, each of whom randomly received placebo and then vaccine, or vice versa, 3 weeks apart, at 14 to 83 months of age. Most of the oldest children had previously been vaccinated against measles, and one half of the remainder of children had had the disease. Symptoms and signs were recorded daily on structured forms. Statistical methods included a complex analysis of the vaccine attributability of the symptoms and conditional logistic regression.
Vaccination-attributable events occurred in 6% overall. At 14 to 18 months of age, reactions developed between days 6 and 14, peaking at day 10. The clearest vaccine-attributable effect was fever exceeding 101.3 degrees F (38. 5 degrees C; odds ratio: 3.28; 95% confidence interval: 2.23-4.82; P <.001), but the same trend was found for rash, arthralgia, conjunctivitis, staying in bed, drowsiness, and irritability. At 6 years of age, systemic reactions occurred 5 to 15 times less frequently, only arthralgia being associated with vaccination. Zygocity, gender, history of allergy, or infections did not modify reactions. Instead, respiratory symptoms developed within days postinjection to a level of 15% to 20% without subsequent decline and with no difference between vaccinees and placebo recipients.
Vaccination was avoided during infections, but many small children became mildly ill within a week or so with no relation to vaccination (the healthy vaccinee effect). MMR vaccine was virtually nonreactogenic when given at 6 years of age. vaccine, measles, mumps, rubella, reactogenicity, adverse events, zygocity, healthy vaccinee effect.
许多国家为控制麻疹而采取的再次接种疫苗政策引发了各种安全问题，包括与第二剂疫苗有关的问题。我们对接受麻疹-腮腺炎-风疹（MMR）疫苗接种的双胞胎进行了一项前瞻性、双盲、交叉试验。
该研究包括1162对同卵和异卵双胞胎，他们在14至83个月大时，每隔3周随机接受安慰剂，然后接种疫苗，或者反之。大多数年龄最大的儿童以前已接种过麻疹疫苗，其余儿童中有一半曾患过麻疹。每天用结构化表格记录症状和体征。统计方法包括对症状的疫苗归因进行复杂分析和条件逻辑回归。
总体上，疫苗接种归因事件发生率为6%。在14至18个月大时，反应在第6至14天出现，在第10天达到峰值。最明显的疫苗归因效应是发热超过101.3华氏度（38.5摄氏度；优势比：3.28；95%置信区间：2.23 - 4.82；P <.001），但皮疹、关节痛、结膜炎、卧床、嗜睡和易怒也呈现相同趋势。在6岁时，全身反应发生频率低5至15倍，只有关节痛与疫苗接种有关。合子性、性别、过敏史或感染史并未改变反应情况。相反，注射后数天内呼吸道症状发生率达到15%至20%，且无后续下降，疫苗接种者和安慰剂接受者之间无差异。
感染期间避免接种疫苗，但许多幼儿在一周左右出现轻度疾病，与疫苗接种无关（健康疫苗接种者效应）。MMR疫苗在6岁接种时几乎无反应原性。疫苗、麻疹、腮腺炎、风疹、反应原性、不良事件、合子性、健康疫苗接种者效应
