Edwards K M, Dupont W D, Westrich M K, Plummer W D, Palmer P S, Wright P F
Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee 37232-2581.
J Infect Dis. 1994 Jan;169(1):68-76. doi: 10.1093/infdis/169.1.68.
A double-blind, randomized controlled trial over 5 years compared the safety, immunogenicity, and efficacy of cold-adapted and inactivated influenza A vaccines in 5210 normal subjects. Both vaccines were well tolerated. Inactivated vaccine significantly increased hemagglutination inhibition antibody titers. Significant titer rises were also noted after cold-adapted vaccine but of lesser magnitude than with inactivated vaccine. The efficacy of inactivated vaccine in preventing culture-positive influenza was 76% (95% confidence interval [CI], 58%-87%) for H1N1 disease and 74% (95% CI, 52%-86%) for H3N2; for cold-adapted vaccine, 85% (95% CI, 70%-92%) and 58% (95% CI, 29%-75%), respectively. The efficacy of inactivated vaccine in preventing a four-fold rise in antibody titer over the influenza season was 69% (95% CI, 61%-76%) for H1N1 and 73% (95% CI, 65%-79%) for H3N2; for cold-adapted vaccine, 54% (95% CI, 44%-62%) and 32% (95% CI, 17%-44%), respectively. Cold-adapted and inactivated influenza vaccines are safe and effective for preventing influenza A disease.
一项为期5年的双盲随机对照试验比较了5210名正常受试者中冷适应甲型流感疫苗和灭活甲型流感疫苗的安全性、免疫原性及有效性。两种疫苗耐受性均良好。灭活疫苗显著提高了血凝抑制抗体滴度。冷适应疫苗接种后也观察到抗体滴度显著升高，但幅度小于灭活疫苗。灭活疫苗预防H1N1疾病培养阳性流感的有效性为76%（95%置信区间[CI]，58%-87%），预防H3N2的有效性为74%（95%CI，52%-86%）；冷适应疫苗的有效性分别为85%（95%CI，70%-92%）和58%（95%CI，29%-75%）。灭活疫苗预防流感季节抗体滴度升高四倍的有效性，H1N1为69%（95%CI，61%-76%），H3N2为73%（95%CI，65%-79%）；冷适应疫苗的有效性分别为54%（95%CI，44%-62%）和32%（95%CI，17%-44%）。冷适应和灭活流感疫苗对预防甲型流感疾病安全有效。
