Caplan E S, Hughes T P, O'Donnel S, Levine M M, Hornick R B
J Infect Dis. 1977 Dec;136 Suppl:S484-90. doi: 10.1093/infdis/136.supplement_3.s484.
Monovalent influenza A/Victoria/3/75 whole-virus vaccines prepared by Merck Sharp and Dohme (West Point, Pa.) and Merrell-National Laboratories (Cincinnati, Ohio) and split-virus vaccines prepared by Parke, Davis and Company (Detroit, Mich.) and Wyeth Laboratories (Philadelphia, Pa.) containing 200, 400, and 800 chick cell-agglutinating units per dose were compared with a placebo in double-blind trials in which 208 adults participated. Titers of hemagglutination-inhibiting antibody of greater than or equal to 1:20 were found in greater than 80% of the volunteers 21 days after vaccination. Seroconversion, defined as a fourfold or greater increase in antibody titer, occurred more frequently among seronegative volunteers than among seropositive volunteers. The geometric mean titers obtained with the whole-virus or split-virus vaccines were not significantly different. Reaction rates had no relation to seroconversion, nor did seronegative subjects have more reactions than seropositive subjects. Local reactions from all vaccines increased with increasing dose. Significantly more overall reactions, "bothersome" reactions, and febrile reactions occurred in the recipients of whole-virus vaccine. Of nine volunteers who reported temperatures of greater than 100 F, one had received split-virus vaccine, seven had received whole-virus vaccine, and one had received the placebo. Most systemic reactions were mild, and all were self-limited.
在一项有208名成年人参与的双盲试验中，将默克夏普&多贺美公司（宾夕法尼亚州西点）和梅里尔-国家实验室（俄亥俄州辛辛那提）制备的单价甲型/维多利亚/3/75全病毒疫苗，以及帕克-戴维斯公司（密歇根州底特律）和惠氏实验室（宾夕法尼亚州费城）制备的含每剂200、400和800鸡胚细胞凝集单位的裂解病毒疫苗与一种安慰剂进行了比较。接种疫苗21天后，超过80%的志愿者血凝抑制抗体效价大于或等于1:20。血清转化定义为抗体效价升高四倍或更多，血清阴性志愿者中血清转化的发生率高于血清阳性志愿者。全病毒疫苗或裂解病毒疫苗获得的几何平均效价没有显著差异。反应率与血清转化无关，血清阴性受试者的反应也不比血清阳性受试者多。所有疫苗的局部反应随剂量增加而增加。全病毒疫苗接种者出现的总体反应、“令人烦恼”的反应和发热反应明显更多。在报告体温高于100华氏度的9名志愿者中，1人接种了裂解病毒疫苗，7人接种了全病毒疫苗，1人接种了安慰剂。大多数全身反应都很轻微，而且都是自限性的。
