Vaccination success rate and reaction profile with diluted and undiluted smallpox vaccine - A randomized controlled trial
Vaccination success rate and reaction profile with diluted and undiluted smallpox vaccine - A randomized controlled trial
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DOI：
10.1001/jama.292.10.1205
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发表时间：
2004-09-08
影响因子：
120.7
通讯作者：
Edwards, KM
中科院分区：
文献类型：
--
作者：
Talbot, TR;Stapleton, JT;Edwards, KM
需要额外的天花疫苗剂量来增加目前美国国家储备。安万特巴斯德天花疫苗（APSV）最初是在20世纪50年代由纽约卫生局的牛痘菌株制成的冷冻制剂，似乎与冻干疫苗一样有效，但稀释剂量的APSV的有效性尚不清楚。目的比较不同APSV稀释剂的接种成功率及反应谱。设计、环境和参与者：在2002年10月9日至2003年2月24日期间，来自3个学术医疗中心的340名年龄在18至32岁之间的健康未接种牛痘的成年人接种了3种APSV稀释剂（未稀释、1:5和1:10）中的一种。每3 ~ 5天随访一次志愿者，直至接种部位愈合，进行绷带更换、疫苗反应评估和不良事件评估，随后进行1 ~ 2个月的临床评估和6个月的电话访谈。成功接种疫苗，定义为接种后6至11天接种部位出现囊泡或脓疱，以及局部和全身对疫苗接种的反应。结果340名志愿者接种疫苗（疫苗剂量：未稀释，n=113； 1:5稀释，n=114； 1:10稀释，n=113）。接种疫苗后，99.4%（95%置信区间[CI]， 97.9%-99.9%）的志愿者成功接种疫苗。稀释组之间的成功率无差异（未稀释，100.0%;95% CI, 96.8%-100.0%； 1:5稀释，98.2%;95% CI, 93.8%-99.8%； 1:10稀释，100.0%,95% CI, 96.8%-100.0%； P=33）。总体而言，99.7%的志愿者在接种部位报告了至少一种局部症状，61.8%患有腋窝淋巴结病，15.0%出现卫星性病变，7.6%在接种部位以外出现皮疹。21.5%出现发烧。3个稀释组的局部或全身反应均无差异（P < 0.05）。由于疫苗相关症状，总共有25%的志愿者错过了预定的工作。结论：即使在稀释剂量下，APSV也是一种有效的天花疫苗，允许扩大目前的储存。然而，反应原性并没有随着疫苗的稀释而降低，而且与其他天花疫苗一样，可能影响日常活动。
Context Additional smallpox vaccine doses are needed to augment current US national stockpile. Aventis Pasteur smallpox vaccine (APSV), initially manufactured in the 1950s from the New York Board of Health vaccinia strain in a frozen preparation, appears as effective as lyophilized vaccine but the effectiveness of diluted doses of APSV is unclear.Objective To compare the vaccination success rate and the reaction profile of various APSV dilutions.Design, Setting, and Participants A double-blind, randomized controlled trial of 340 healthy vaccinia-naive adults aged 18 to 32 years from 3 academic medical centers who were vaccinated with 1 of 3 strengths of APSV dilutions (undiluted, 1:5, and 1: 10) between October 9, 2002, and February 24, 2003. Volunteers were followed up every 3 to 5 days until the vaccination site healed for bandage changes, vaccine response assessment, and adverse event evaluation, followed by 1- and 2-month clinic evaluations and 6-month telephone interview.Main Outcome Measures Successful vaccination, defined by presence of a vesicle or pustule at the inoculation site 6 to 11 days postvaccination, and local and systemic reactions to vaccination.Results A total of 340 volunteers were vaccinated (vaccine dose: undiluted, n=113; 1:5 dilution, n=114; and 1:10 dilution, n=113). Following vaccination, 99.4% (95% confidence interval [CI], 97.9%-99.9%) of all volunteers had successful vaccinations. Success rates did not differ between the dilution groups (undiluted, 100.0%; 95% CI, 96.8%-100.0%; 1:5 dilution, 98.2%; 95% CI, 93.8%-99.8%; 1:10 dilution, 100.0% 95% CI, 96.8%-100.0%; P=33). Overall, 99.7% of volunteers reported at least 1 local symptom at the vaccination site, and 61.8% had axillary lymphadenopathy, 15.0% developed satellite lesions, and 7.6% developed a rash away from the vaccination site. Fever developed in 21.5%. No differences were noted in local or systemic reactions between the 3 dilution groups (P>.05 for each comparison). A total of 25% of volunteers missed scheduled duties due to vaccine-related symptoms.Conclusions Even at diluted doses, APSV is an effective smallpox vaccine, allowing for expansion of the current stockpile. However, reactogenicity was not reduced with dilution of the vaccine and, as with other smallpox vaccines, may impair daily activities.