Quinnan G V, Schooley R, Dolin R, Ennis F A, Gross P, Gwaltney J M
Rev Infect Dis. 1983 Jul-Aug;5(4):748-57. doi: 10.1093/clinids/5.4.748.
Four hundred twenty-six volunteers aged 16 to 83 years were given experimental doses of inactivated monovalent [A/USSR/77 (H1N1)] and trivalent [A/USSR/77 (H1N1), A/Texas/77 (H3N2), B/Hong Kong/72] influenza vaccines as part of a double-blinded, placebo-controlled, national collaborative study. Local reactions at inoculation sites occurred in less than 6.6% of volunteers. Systemic reactions, generally consisting of low-grade fever, myalgia, or headache, lasting less than 24 hr, did not occur more frequently in vaccinees than in placebo recipients. Vaccines containing lower doses of the A/Texas/77 (H3N2) hemagglutinin (8-10 micrograms) and B/Hong Kong/72 hemagglutinin (6-9 micrograms) produced hemagglutinin-inhibiting (HAI) antibody responses equivalent to those produced by higher doses (15-28 and 19-28 micrograms, respectively) in all age groups. Single injections of vaccines containing lower doses of A/USSR/77 (H1N1) hemagglutinin (4-7 micrograms) induced titers of HAI antibody of greater than 1:40 in 93% of volunteers greater than or equal to 26 years of age but in only 58% of volunteers less than 26 years of age. In this latter group, two injections containing higher doses (10-19 micrograms) induced better antibody responses. Vaccines containing approximately 6-15 micrograms of hemagglutinin of each antigen can be expected to be well tolerated and to induce good HAI antibody responses in a one- or two-dose regimen, depending on the age group.
作为一项双盲、安慰剂对照的全国性合作研究的一部分,426名年龄在16至83岁之间的志愿者接种了实验剂量的单价[甲型/苏联/77(H1N1)]和三价[甲型/苏联/77(H1N1)、甲型/得克萨斯/77(H3N2)、乙型/香港/72]流感疫苗。接种部位的局部反应发生在不到6.6%的志愿者身上。全身反应一般包括低热、肌痛或头痛,持续时间不到24小时,在接种疫苗者中出现的频率并不高于安慰剂接受者。含有较低剂量的甲型/得克萨斯/77(H3N2)血凝素(8 - 10微克)和乙型/香港/72血凝素(6 - 9微克)的疫苗在所有年龄组中产生的血凝素抑制(HAI)抗体反应与较高剂量(分别为15 - 28微克和19 - 28微克)产生的反应相当。单次注射含有较低剂量的甲型/苏联/77(H1N1)血凝素(4 - 7微克)的疫苗,在93%年龄大于或等于26岁的志愿者中诱导出大于1:40的HAI抗体滴度,但在年龄小于26岁的志愿者中只有58%。在后者组中,两次注射较高剂量(10 - 19微克)诱导出更好的抗体反应。根据年龄组的不同,预计含有每种抗原约6 - 15微克血凝素的疫苗在单剂量或两剂量方案中耐受性良好,并能诱导良好的HAI抗体反应。