Karron R A, Steinhoff M C, Subbarao E K, Wilson M H, Macleod K, Clements M L, Fries L F, Murphy B R
Department of International Health, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, MD 21205, USA.
Pediatr Infect Dis J. 1995 Jan;14(1):10-6. doi: 10.1097/00006454-199501000-00002.
A safe and effective influenza vaccine is needed to prevent serious influenza illness in infants younger than 6 months of age. The purpose of this study was to determine whether two doses of the cold-adapted (ca) influenza A reassortant vaccine would be safe and immunogenic in this age group. In the first part of this study, infants received two doses of 10(5) or 10(6) 50% tissue culture-infectious dose (TCID50) of the ca influenza vaccine separately from routine immunizations. In the second part of this study two 10(6) TCID50 doses of the ca influenza vaccine were given with routine immunizations at 2 and 4 or 2 and 6 months of age. The ca influenza vaccine was well-tolerated by participants in both parts of this study. Two doses of the ca influenza vaccine were immunogenic in infants who received them separately from routine immunizations; 83% of vaccinees developed protective titers of serum hemagglutination-inhibition (HAI) antibody. In contrast, when the ca vaccine was administered with routine immunizations, protective HAI antibody titers were induced in only 20% of those immunized at 2 and 4 months of age and 50% of those immunized at 2 and 6 months of age. There were no statistically significant associations between HAI antibody response to ca influenza vaccination and dose schedule, presence of passively acquired maternal HAI antibody, ethnic group or breast-feeding status. Young age at the time of first immunization, however, appeared to correlate with decreased response to the hemagglutinin antigen of the influenza A virus.(ABSTRACT TRUNCATED AT 250 WORDS)
需要一种安全有效的流感疫苗来预防6个月以下婴儿的严重流感疾病。本研究的目的是确定两剂冷适应（ca）甲型流感重组疫苗在该年龄组中是否安全且具有免疫原性。在本研究的第一部分，婴儿分别接受两剂10(5)或10(6) 50%组织培养感染剂量（TCID50）的ca流感疫苗，与常规免疫分开进行。在本研究的第二部分，在2个月和4个月或2个月和6个月龄时，将两剂10(6) TCID50的ca流感疫苗与常规免疫一起接种。本研究两部分的参与者对ca流感疫苗耐受性良好。两剂ca流感疫苗在与常规免疫分开接种的婴儿中具有免疫原性；83%的接种者产生了血清血凝抑制（HAI）抗体的保护性滴度。相比之下，当ca疫苗与常规免疫一起接种时，在2个月和4个月龄接种的人中只有20%诱导出保护性HAI抗体滴度，在2个月和6个月龄接种的人中只有50%诱导出保护性HAI抗体滴度。对ca流感疫苗的HAI抗体反应与剂量方案、被动获得的母体HAI抗体的存在、种族或母乳喂养状况之间没有统计学上的显著关联。然而，首次免疫时年龄较小似乎与对甲型流感病毒血凝素抗原的反应降低相关。（摘要截短于250字）
