黄热病和伤寒联合免疫接种的比较试验

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为评价冻干黄热病17D(YF)减毒活疫苗和液体伤寒Vi多糖(ViPS)菌苗联合免疫的效果,作者将209名志愿者分成4组。A组单独接种YF疫苗,B组于不同部位同时接种YF疫苗和ViPS菌苗,C组接种以液体ViPS菌苗为稀释剂的YF疫苗(联合疫苗),D组单独接种ViPS菌苗。接种方法为一侧或双侧上臂三角肌区皮下注射,剂量均为0.5ml。对志愿者于接种疫苗当天进行体检和采血。接种后7天再次体检。以局部红晕和硬结大小(直径,cm)打分,0分(无反应),1分(0.5~1.5cm),2分(2~3cm),3分(>3cm)。以注射局部疼痛程度打分,0分(无痛感),1分(压痛),2分(影响运动),3分(影响睡眠)。据此计分,最大的平均局部症状总分(TLSS)为72。于接种疫苗后35天采血,用蚀斑抑制试验(PRT)测定抗YF病毒中和抗体,若蚀斑减少80%则认为血清阳性。用放射免疫试验(RIA)检测特异性抗Vi抗体,免疫后血清抗体水平增高0.15μg/ml以上,判为阳转。 结果表明,各组未见明显的全身症状,并且局部反应轻微,持续时间短。平均TLSS值:A组5.3,B组4.0(YF)/8.4(ViPS),C组9.5,D组6.2。统计学分析表明,与单独接种YF和ViPS疫苗相比,两种疫苗分部位同时接种或接种联合疫苗对局部和全身反应,疫苗的安全性和耐受性均无不良影响。 To evaluate the combined immunization of the 17D (YF) live attenuated vaccine against lyophilized yellow fever and the liquid Vi-Vi vaccine, 209 volunteers were divided into 4 groups. Group A received YF vaccine alone, Group B received both YF vaccine and ViPS vaccine at different sites, Group C received YF vaccine (combination vaccine) diluted with liquid ViPS vaccine, and Group D received ViPS vaccine alone. Inoculation method for one or both sides of the upper arm deltoid subcutaneous injection, the dose was 0.5ml. Volunteers were vaccinated on the day of physical examination and blood sampling. 7 days after inoculation again physical examination. Points were scored on local blush and induration size (diameter, cm), 0 points (no response), 1 point (0.5-1.5 cm), 2 points (2-3 cm), and 3 points (> 3 cm). Score local pain by injection, 0 (no pain), 1 point (tenderness), 2 points (affect exercise), 3 points (affect sleep). Based on this score, the largest mean local symptom score (TLSS) was 72. Blood was collected 35 days after vaccination and the anti-YF virus neutralizing antibody was tested by the plaque inhibition test (PRT) and seropositive if the plaque was reduced by 80%. By radioimmunoassay (RIA) detection of specific anti-Vi antibody, serum antibody levels increased by 0.15μg / ml or more, the sentence was positive. The results showed that no obvious systemic symptoms in each group, and mild local reactions, short duration. Average TLSS values: Group A 5.3, Group B 4.0 (YF) /8.4 (ViPS), Group C 9.5, Group D 6.2. Statistical analysis showed that both vaccine sub-site vaccination or combination vaccination had no adverse effect on local and systemic responses, vaccine safety and tolerability compared with YF and ViPS vaccination alone.
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