Chernyshova T F, Mishina A I, Pavlova L I, Pokrovskaia N Ia, Sokolova T V
Zh Mikrobiol Epidemiol Immunobiol. 1987 May(5):54-8.
In the controlled trial carried out among children aged 1-4 years, the safety, reactogenicity and immunological potency of group A meningococcal polysaccharide vaccine produced at the Gabrichevskiĭ Research Institute of Epidemiology and Microbiology (Moscow) were studied. The vaccine under test was introduced in two doses containing 15 and 25 micrograms of meningococcal polysaccharide. Both doses were shown to be safe, faintly reactogenic and immunologically potent. Systemic reactions were manifested by a transient rise in temperature to subfebrile levels in 19% and to 37.8-38.2 degrees C in 4.7% of the vaccinees. The temperature dropped to the normal level by the end of the first day following vaccination. At the site of injection skin hyperemia up to 2-3 cm in diameter was registered in 74% and up to 5-6 cm in diameter, in 6% of the vaccinees. Hyperemia disappeared on day 2 after vaccination. The production of antibodies to group A meningococcal polysaccharide occurred in response to both doses under test, and the elevated antibody level (in comparison to the initial one) was retained perceptibly longer in response to a dose of 25 micrograms; this dose, considering its low reactogenicity, was chosen as the optimal dose for children of the above age group.
在对1至4岁儿童进行的对照试验中,研究了加布里切夫斯基流行病学和微生物学研究所(莫斯科)生产的A群脑膜炎球菌多糖疫苗的安全性、反应原性和免疫效力。受试疫苗分两剂接种,每剂含15微克和25微克脑膜炎球菌多糖。两剂疫苗均显示安全、反应原性轻微且免疫效力良好。全身反应表现为19%的接种者体温短暂升至低热水平,4.7%的接种者体温升至37.8 - 38.2摄氏度。接种后第一天结束时体温降至正常水平。74%的接种者注射部位出现直径达2 - 3厘米的皮肤充血,6%的接种者直径达5 - 6厘米。接种后第2天充血消失。对受试的两剂疫苗均产生了针对A群脑膜炎球菌多糖的抗体,与25微克剂量相比,对15微克剂量的反应中,抗体水平升高后明显维持时间更长;考虑到其低反应原性,25微克这一剂量被选为上述年龄组儿童的最佳剂量。