Kilbourne E D, Couch R B, Kasel J A, Keitel W A, Cate T R, Quarles J H, Grajower B, Pokorny B A, Johansson B E
Department of Microbiology and Immunology, New York Medical College, Valhalla 10595, USA.
Vaccine. 1995 Dec;13(18):1799-803. doi: 10.1016/0264-410x(95)00127-m.
The immunogenicity and toxicity of a purified influenza virus (N2) neuraminidase vaccine (NAV) were investigated in 88 human subjects aged 18-40, and compared to response to a conventional trivalent influenza vaccine, Fluogen (Parke-Davis). NAV doses ranged from 2.6 to 69.9 micrograms and were given intramuscularly. Serologic neuraminidase-inhibiting (NI) and neuraminidase-specific ELISA responses in this N2-primed population were roughly proportional to the dose administered. Maximal response was seen in 14-21 days and NI antibody titers persisted unabated for the 6-month post-vaccination follow-up period. All doses were well tolerated with respect to local and systemic reactions. NI tests performed with the putative (1975) priming N2 antigen demonstrated anamnestic response but did not reveal responses not already shown with the homologous (1992) antigen. Response to this purified, non-adjuvanted preparation encourages continuing investigation of the induction of infection-permissive immunity with influenza virus neuraminidase.
在88名年龄在18至40岁的人类受试者中研究了纯化流感病毒（N2）神经氨酸酶疫苗（NAV）的免疫原性和毒性，并与传统三价流感疫苗Fluogen（帕尔克-戴维斯公司生产）的反应进行比较。NAV剂量范围为2.6至69.9微克，通过肌肉注射给药。在这个以N2为初始免疫的人群中，血清学神经氨酸酶抑制（NI）和神经氨酸酶特异性ELISA反应大致与给药剂量成正比。最大反应在14至21天出现，并且在疫苗接种后的6个月随访期内，NI抗体滴度持续未减。所有剂量在局部和全身反应方面耐受性良好。用假定的（1975年）初始免疫N2抗原进行的NI试验显示出回忆反应，但未揭示用同源（1992年）抗原未显示出的反应。对这种纯化的、无佐剂制剂的反应鼓励继续研究流感病毒神经氨酸酶诱导允许感染免疫的情况。
