Palache A M, Brands R, van Scharrenburg G J
Solvay Pharmaceuticals, Weesp, The Netherlands.
J Infect Dis. 1997 Aug;176 Suppl 1:S20-3. doi: 10.1086/514169.
A tissue culture method using MDCK cells grown under serum-free conditions was developed to produce an inactivated influenza subunit vaccine. The first clinical data suggest it to be equal to the conventional egg-derived influenza subunit vaccine. In a double-blind controlled trial, 2 groups (n = 57 each) of adult volunteers were immunized with experimental bivalent influenza subunit vaccine derived from either MDCK cells or hens' eggs. Each vaccine contained 15 microg of hemagglutinin of influenza A/Taiwan/1/186 (H1N1) and 15 microg of hemagglutinin of B/Panama/45/90. No clinically relevant adverse reactions were observed in either vaccine group, and the incidence of systemic and local vaccine reactions was comparable in both groups. Standard hemagglutination inhibition antibody titers were determined using both MDCK- and egg-derived test antigens. The data reveal that both vaccines are safe and well-tolerated and meet the criteria for immunogenicity as stated in the European Community's "Harmonisation of Requirements for Influenza Vaccines."
开发了一种使用在无血清条件下培养的MDCK细胞的组织培养方法来生产灭活流感亚单位疫苗。首批临床数据表明其效果等同于传统的鸡蛋源流感亚单位疫苗。在一项双盲对照试验中，两组（每组n = 57）成年志愿者分别接种了源自MDCK细胞或鸡蛋的实验性二价流感亚单位疫苗。每种疫苗均含有15微克甲型流感病毒/台湾/1/186（H1N1）血凝素和15微克乙型流感病毒/巴拿马/45/90血凝素。两个疫苗组均未观察到临床相关不良反应，且两组全身和局部疫苗反应的发生率相当。使用源自MDCK细胞和鸡蛋的测试抗原来测定标准血凝抑制抗体滴度。数据显示两种疫苗均安全且耐受性良好，并符合欧洲共同体“流感疫苗要求协调”中所述的免疫原性标准。
