Kanra G, Ceyhan M, Ozmert E
Hacettepe University Faculty of Medicine, Pediatric Infectious Disease Unit, Ankara, Turkey.
Pediatr Int. 2000 Dec;42(6):674-7. doi: 10.1046/j.1442-200x.2000.01300.x.
The present study was conducted to evaluate the safety and immunogenicity of live attenuated varicella vaccine (Oka-strain) in 9-month-old infants.
One hundred and fourteen infants were vaccinated once with live attenuated varicella vaccine (Valrix; SmithKline Beecham Biologicals, Rixensart, Belgium) containing a mean virus titer of 10(4.0) plaque-forming units (p.f.u.) per dose. Signs and/or symptoms after vaccination were followed for 42 days. Home visits were made to detect solicited local reactions (0-3 days) and solicited general reactions (0-21 days), as well as unsolicited reactions. Specific varicella antibodies were determined by an indirect immunofluorescence method. The geometric mean titer and seroconversion rate were calculated.
Signs and/or symptoms were reported in 47.4% (54/114) of cases following vaccination. The only local symptom reported was pain on digital pressure at the injection site and this was reported in 28.1% (32/114) of infants. General symptoms were reported in 38.6% (44/114) of cases. The most frequently reported findings were fever (27.2%), which was mostly mild, restlessness (20.2%) and cough (11.4%). Only four unsolicited symptoms were reported and they were all unrelated to vaccination. No serious adverse event was reported. Of the 109 infants included in the immunogenicity analysis, 105 were seronegative and four were seropositive for antibodies against varicella before vaccination. The vaccine elicited seroconversion in 97.1% of initially seronegative cases. The post-vaccination geometric mean titer for these infants was 30.9 geometric mean titer (GMT).
The vaccine was found to be safe and immunogenic when given to infants as young as 9 months of age. This may be of clinical significance during outbreaks of varicella and especially for developing countries.
本研究旨在评估减毒活水痘疫苗（Oka株）在9月龄婴儿中的安全性和免疫原性。
114名婴儿接种一次减毒活水痘疫苗（Varilrix；比利时里克森萨特史克必成生物制品公司），每剂平均病毒滴度为10(4.0) 蚀斑形成单位（p.f.u.）。接种疫苗后的体征和/或症状随访42天。进行家访以检测预期的局部反应（0 - 3天）和预期的全身反应（0 - 21天）以及非预期反应。采用间接免疫荧光法测定特异性水痘抗体。计算几何平均滴度和血清转化率。
接种疫苗后47.4%（54/114）的病例报告了体征和/或症状。报告的唯一局部症状是注射部位指压疼痛，28.1%（32/114）的婴儿出现此症状。38.6%（44/114）的病例报告了全身症状。最常报告的症状是发热（27.2%），大多为轻度，烦躁不安（20.2%）和咳嗽（11.4%）。仅报告了4例非预期症状，且均与接种疫苗无关。未报告严重不良事件。在纳入免疫原性分析的109名婴儿中，105名接种疫苗前水痘抗体血清学阴性，4名血清学阳性。该疫苗在97.1%的初始血清学阴性病例中引发了血清转化。这些婴儿接种疫苗后的几何平均滴度为30.9几何平均滴度（GMT）。
发现该疫苗在给9月龄婴儿接种时是安全且具有免疫原性的。这在水痘暴发期间可能具有临床意义，特别是对于发展中国家。
