Straus S E, Wald A, Kost R G, McKenzie R, Langenberg A G, Hohman P, Lekstrom J, Cox E, Nakamura M, Sekulovich R, Izu A, Dekker C, Corey L
Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892, USA.
J Infect Dis. 1997 Nov;176(5):1129-34. doi: 10.1086/514103.
To determine the safety, immunogenicity, and efficacy of a recombinant herpes simplex virus type 2 glycoprotein D and B vaccine in the treatment of recurrent genital herpes, a randomized, placebo-controlled trial was held at two referral centers. Healthy patients with 4-14 recurrences per year received injections of both glycoproteins in MF59 adjuvant or of MF59 alone at 0, 2, 12, and 14 months. For 18 study months, the rate and number of recurrences, the duration and severity of the first confirmed recurrence, vaccine immunogenicity, and rates of local and systemic reactions were determined. The monthly rate of recurrences was not significantly improved, but the duration and severity of the first study outbreak was reduced significantly by vaccination. Glycoprotein-specific and neutralizing antibodies were boosted by vaccination for the duration of the study. This vaccine is safe and immunogenic and ameliorated an observed first postvaccination genital recurrence, but it does not reduce recurrence frequency.
为确定重组2型单纯疱疹病毒糖蛋白D和B疫苗治疗复发性生殖器疱疹的安全性、免疫原性和疗效，在两个转诊中心进行了一项随机、安慰剂对照试验。每年复发4 - 14次的健康患者在0、2、12和14个月时接受MF59佐剂中两种糖蛋白的注射或仅注射MF59。在18个研究月期间，确定复发率和复发次数、首次确诊复发的持续时间和严重程度、疫苗免疫原性以及局部和全身反应率。每月复发率没有显著改善，但接种疫苗后首次研究发作的持续时间和严重程度显著降低。在研究期间，接种疫苗可增强糖蛋白特异性和中和抗体。这种疫苗是安全且具有免疫原性的，并且改善了接种疫苗后首次观察到的生殖器复发情况，但并未降低复发频率。
