Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Vaccine. 2011 Sep 16;29(40):7042-8. doi: 10.1016/j.vaccine.2011.07.031. Epub 2011 Jul 22.
To evaluate the safety, tolerability, immunogenicity, and viral shedding profiles of a recombinant, live, attenuated human parainfluenza virus type 3 (HPIV3) vaccine, rHPIV3cp45, in healthy HPIV3-seronegative infants 6 to <12 months of age.
In this double-blind, multicenter study, subjects were randomized 2:1 to receive a 10(5)TCID(50) dose of rHPIV3cp45 (n=20) or placebo (n=10) at enrollment and at 2 and 4 months after the first dose. Blood for evaluation of antibody to HPIV3 was collected at baseline and approximately 1 month after each dose. Solicited adverse events (SEs) and unsolicited adverse events (AEs) were collected on days 0-28 after each dose. Nasal wash samples for vaccine virus shedding were collected 3 times after each dose (7-10, 12-18, and 28-34 days post dose) and at unscheduled illness visits. Subjects were followed for 180 days after the last dose.
Vaccine virus was shed by 85% of vaccine recipients after dose 1, by 1 subject after dose 2, and was not shed by any subject after dose 3. The highest titer of shed virus was detected on day 7 after dose 1. The attenuation phenotype and the genotype of the vaccine virus were stable in shed virus. Seroresponse (≥ 4-fold rise in HPIV3 antibody from baseline) occurred in 61% of subjects after dose 1 and in 77% after dose 3. Either seroresponse or shedding occurred in 95% of vaccine subjects. Adverse events were similar in vaccine and placebo recipients.
The safety, shedding, and immunogenicity profiles of rHPIV3cp45 in HPIV3-seronegative infants 6 to <12 months of age support further development of this vaccine.
评估重组、活、减毒人副流感病毒 3 型（HPIV3）疫苗 rHPIV3cp45 在健康的 HPIV3 血清阴性 6 至<12 个月龄婴儿中的安全性、耐受性、免疫原性和病毒脱落情况。
在这项双盲、多中心研究中，受试者按 2:1 的比例随机分组，分别接受 10(5)TCID(50)剂量的 rHPIV3cp45（n=20）或安慰剂（n=10），在首次接种和首次接种后 2 个月和 4 个月时接种。在基线和每次接种后大约 1 个月采集用于评估对 HPIV3 抗体的血样。在每次接种后 0-28 天收集应征不良反应（SE）和未应征不良反应（AE）。在每次接种后 3 次（接种后第 7-10、12-18 和 28-34 天）和非计划疾病就诊时采集鼻洗液样本以检测疫苗病毒脱落。在末次接种后 180 天对受试者进行随访。
疫苗接种者在第 1 次接种后 85%的人有疫苗病毒脱落，1 人在第 2 次接种后有病毒脱落，第 3 次接种后没有人有病毒脱落。接种后第 1 天检测到最高的脱落病毒滴度。脱落病毒的减毒表型和基因型稳定。第 1 次接种后，61%的受试者、第 3 次接种后 77%的受试者出现血清学应答（与基线相比，HPIV3 抗体升高≥4 倍）。95%的疫苗接种者出现血清学应答或病毒脱落。疫苗和安慰剂组的不良事件相似。
rHPIV3cp45 在 HPIV3 血清阴性 6 至<12 个月龄婴儿中的安全性、脱落和免疫原性特征支持进一步开发该疫苗。
