Fractional Doses of Inactivated Poliovirus Vaccine in Oman.
Fractional Doses of Inactivated Poliovirus Vaccine in Oman.
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DOI：
10.1056/nejmoa0909383
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发表时间：
2010-06-24
影响因子：
158.5
通讯作者：
Sutter, Roland W.
中科院分区：
文献类型：
--
作者：
Mohammed, Ali Jafer;AlAwaidy, Salah;Sutter, Roland W.
背景资料：我们对阿曼的婴儿接种部分剂量的灭活脊髓灰质炎病毒疫苗进行了临床试验，以评估使疫苗在发展中国家使用的可负担性的策略。方法：我们比较了部分剂量的灭活脊髓灰质炎病毒疫苗（0.1ml，代表全剂量的五分之一），使用无针喷射注射器装置皮内给药，在免疫原性和反应原性方面，肌肉注射全剂量疫苗。婴儿在出生时被随机分配，在2、4和6个月时接受部分剂量或全剂量的灭活脊髓灰质炎病毒疫苗。我们还管理了一个挑战剂量的单价1型口服脊髓灰质炎病毒疫苗在7个月，并收集粪便样本之前和7天后，管理的挑战dose.Results：共400名婴儿进行了随机化，其中373（93.2%）符合研究要求。未检测到组间的显著基线差异。完成三剂方案后30天，分次剂量组中1型、2型和3型脊髓灰质炎病毒的血清转换率分别为97.3%、95.7%和97.9%，而全剂量组中所有血清型的血清转换率均为100（2型脊髓灰质炎病毒的比较P=0.01; 1型和3型脊髓灰质炎病毒的结果不显著）。分次剂量组的中位滴度明显低于全剂量组（P
Background: We conducted a clinical trial of fractional doses of inactivated poliovirus vaccine administered to infants in Oman, in order to evaluate strategies for making the vaccine affordable for use in developing countries.Methods: We compared fractional doses of inactivated poliovirus vaccine (0.1 ml, representing one fifth of a full dose) given intradermally with the use of a needle-free jet injector device, with full doses of vaccine given intramuscularly, with respect to immunogenicity and reactogenicity. Infants were randomly assigned at birth to receive either a fractional dose or a full dose of inactivated poliovirus vaccine at 2, 4, and 6 months. We also administered a challenge dose of monovalent type 1 oral poliovirus vaccine at 7 months and collected stool samples before and 7 days after administration of the challenge dose.Results: A total of 400 infants were randomized, of whom 373 (93.2%) fulfilled the study requirements. No significant baseline differences between the groups were detected. Thirty days after completion of the three-dose schedule, the rates of seroconversion to types 1, 2, and 3 poliovirus were 97.3%, 95.7%, and 97.9%, respectively, in the fractional-dose group, as compared with 100% seroconversion to all serotypes in the full-dose group (P=0.01 for the comparison with respect to type 2 poliovirus; results with respect to types 1 and 3 poliovirus were not significant). The median titers were significantly lower in the fractional-dose group than in the full-dose group (P