Belshe Robert B, Newman Frances K, Tsai Theodore F, Karron Ruth A, Reisinger Keith, Roberton Don, Marshall Helen, Schwartz Richard, King James, Henderson Frederick W, Rodriguez William, Severs Joseph M, Wright Peter F, Keyserling Harry, Weinberg Geoffrey A, Bromberg Kenneth, Loh Richard, Sly Peter, McIntyre Peter, Ziegler John B, Hackell Jill, Deatly Anne, Georgiu Alice, Paschalis Maribel, Wu Shin-Lu, Tatem Joanne M, Murphy Brian, Anderson Edwin
Division of Infectious Diseases and Immunology, Saint Louis University, St. Louis, Missouri, USA.
J Infect Dis. 2004 Feb 1;189(3):462-70. doi: 10.1086/381184. Epub 2004 Jan 20.
A phase 2 evaluation of live attenuated parainfluenza type 3 (PIV3)-cold passage mutant 45 (cp45) vaccine was conducted in 380 children 6-18 months old; 226 children (59%) were seronegative for PIV3. Of the 226 seronegative children, 114 received PIV3-cp45 vaccine, and 112 received placebo. No significant difference in the occurrence of adverse events (i.e., runny nose, cough, or temperature > or =38 degrees C) was noted during the 14 days after vaccination. There was no difference between groups in the occurrence of acute otitis media or serous otitis media. Paired serum samples were available for 109 of the seronegative vaccine recipients and for 110 of the seronegative placebo recipients; 84% of seronegative vaccine recipients developed a > or =4-fold increase in antibody titers. The geometric mean antibody titer after vaccination was 1 : 25 in the vaccine group and <1 : 4 in the placebo group. PIV3-cp45 vaccine was safe and immunogenic in seronegative children and should be evaluated for efficacy in a phase 3 field trial.
对380名6至18个月大的儿童进行了3型副流感病毒（PIV3）冷传代突变体45（cp45）减毒活疫苗的2期评估；226名儿童（59%）PIV3血清学阴性。在226名血清学阴性儿童中，114名接受了PIV3-cp45疫苗，112名接受了安慰剂。接种疫苗后14天内，不良事件（即流鼻涕、咳嗽或体温≥38摄氏度）的发生率无显著差异。两组在急性中耳炎或浆液性中耳炎的发生率上无差异。109名血清学阴性的疫苗接种者和110名血清学阴性的安慰剂接受者可获得配对血清样本；84%的血清学阴性疫苗接种者抗体滴度升高≥4倍。疫苗组接种疫苗后的几何平均抗体滴度为1:25，安慰剂组<1:4。PIV3-cp45疫苗在血清学阴性儿童中安全且具有免疫原性，应在3期现场试验中评估其疗效。
