Greenberg David P, Walker Robert E, Lee Min-Shi, Reisinger Keith S, Ward Joel I, Yogev Ram, Blatter Mark M, Yeh Sylvia H, Karron Ruth A, Sangli Chithra, Eubank Lane, Coelingh Kathleen L, Cordova Julie M, August Marilyn J, Mehta Harshvardhan B, Chen Wendy, Mendelman Paul M
University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.
J Infect Dis. 2005 Apr 1;191(7):1116-22. doi: 10.1086/428092. Epub 2005 Feb 22.
A phase 2 trial was conducted to assess in young infants the safety, tolerability, infectivity, and immunogenicity of multiple doses of an intranasal vaccine using bovine parainfluenza virus type 3 (bPIV3).
One hundred ninety-two healthy 2-month-old infants were randomized 1 : 1 : 1 to receive 1x10(5) median tissue culture infective dose (TCID(50)) bPIV3 vaccine, 1x10(6) TCID(50) bPIV3 vaccine, or placebo at 2, 4, 6, and 12-15 months of age. Safety information was collected by use of diary sheets and telephone interviews. Nasal wash and serum specimens were collected for assessment of infectivity and immunogenicity.
The safety profiles of both dosages of bPIV3 were similar to that of placebo, with the exception of fever with temperature of >/=38.1 degrees C after dose 2 only, occurring in 34% of the 1x10(5) TCID(50) group, 35% of the 1x10(6) TCID(50) group, and 12% of the placebo group (P<.01). No vaccine-related serious adverse events were reported. The cumulative vaccine infectivity (isolation of bPIV3 and/or bPIV3 seroconversion) after dose 3 was similar in the 2 vaccine groups (87% in the 1x10(5) TCID(50) group and 77% in the 1x10(6) TCID(50) group) (P=.46). Seroconversion rates after dose 3, assessed by means of hemagglutination inhibition assay, after adjustment for decrease in maternal antibody titers, were 67% in the 1x10(5) TCID(50) group, 57% in the 1x10(6) TCID(50) group, and 12% in the placebo group (P<.01). Isolation of bPIV3 was common after dose 1, dose 2, or dose 3, but only 1 of 51 participants in the vaccine groups had bPIV3 isolated after dose 4.
Multiple doses of bPIV3 vaccine were well tolerated and immunogenic in young infants.
开展了一项2期试验，以评估多剂量鼻内接种牛副流感病毒3型（bPIV3）疫苗在幼儿中的安全性、耐受性、感染性和免疫原性。
192名健康的2月龄婴儿按1:1:1随机分组，在2、4、6和12 - 15月龄时分别接受1×10⁵半数组织培养感染剂量（TCID₅₀）的bPIV3疫苗、1×10⁶TCID₅₀的bPIV3疫苗或安慰剂。通过使用日记表和电话访谈收集安全信息。收集鼻洗液和血清标本以评估感染性和免疫原性。
两种剂量bPIV3的安全性概况与安慰剂相似，但仅在第2剂后出现体温≥38.1℃的发热情况，在1×10⁵TCID₅₀组中占34%，1×10⁶TCID₅₀组中占35%，安慰剂组中占12%（P<0.01）。未报告与疫苗相关的严重不良事件。第3剂后，两个疫苗组的累积疫苗感染性（bPIV3分离和/或bPIV3血清转化）相似（1×10⁵TCID₅₀组为87%，1×10⁶TCID₅₀组为77%）（P = 0.46）。通过血凝抑制试验评估，在调整母体抗体滴度下降后，第3剂后的血清转化率在1×10⁵TCID₅₀组中为67%，1×10⁶TCID₅₀组中为57%，安慰剂组中为12%（P<0.01）。在第1剂、第2剂或第3剂后bPIV3分离很常见，但疫苗组51名参与者中只有1人在第4剂后分离出bPIV3。
多剂量bPIV3疫苗在幼儿中耐受性良好且具有免疫原性。
