Anderson E L, Kennedy D J, Geldmacher K M, Donnelly J, Mendelman P M
Department of Pediatric, St. Louis University School of Medicine, Missouri, USA.
J Pediatr. 1996 May;128(5 Pt 1):649-53. doi: 10.1016/s0022-3476(96)80130-2.
To evaluate the safety, immunogenicity, and immunologic memory in young infants of a seven-valent (6B, 14, 19F, 23F, 18C, 4, 9V) pneumococcal vaccine conjugated to the outer membrane protein complex of Neisseria meningitidis. VACCINEES: Healthy 2-month-old infants 12- to 15-month-old control infants were recruited from participating private practices.
Infants (n = 25) were vaccinated at 2, 4, and 6 months of age with the conjugated pneumococcal vaccine, followed by a single dose of licensed pneumococcal polysaccharide vaccine (n = 20) at 12 to 15 months of age. Thirteen infants who had not received the investigational pneumococcal conjugate vaccine served as control subjects and were given a single dose of the licensed pneumococcal polysaccharide vaccine at 12 to 15 months of age.
The investigational pneumococcal conjugate vaccine was well tolerated by infants. The vaccine was highly immunogenic in young infants, with significant increases in antibody to all seven serotypes after either two or three injections. At 12 to 15 months of age, infants who had been primed with the investigational pneumococcal conjugate vaccine had a brisk immunologic response to the booster injection of the licensed pneumococcal polysaccharide vaccine. Control infants, who received a single primary injection of the licensed pneumococcal polysaccharide vaccine, had negligible immunologic responses to four of the seven serotypes and low responses to the other three types.
The investigational seven-valent pneumococcal conjugate vaccine administered to young infants was well tolerated and highly immunogenic and provided immunologic memory to an injection of the licensed pneumococcal polysaccharide vaccine.
评估与脑膜炎奈瑟菌外膜蛋白复合物结合的七价（6B、14、19F、23F、18C、4、9V）肺炎球菌疫苗在小婴儿中的安全性、免疫原性和免疫记忆。疫苗接种对象：从参与研究的私人诊所招募健康的2月龄婴儿及12至15月龄的对照婴儿。
25名婴儿在2、4和6月龄接种结合肺炎球菌疫苗，随后在12至15月龄接种一剂已获许可的肺炎球菌多糖疫苗（20名）。13名未接种试验性肺炎球菌结合疫苗的婴儿作为对照，在12至15月龄接种一剂已获许可的肺炎球菌多糖疫苗。
试验性肺炎球菌结合疫苗在婴儿中耐受性良好。该疫苗在小婴儿中具有高度免疫原性，两次或三次注射后，所有七种血清型的抗体均显著增加。在12至15月龄时，用试验性肺炎球菌结合疫苗进行初免的婴儿对已获许可的肺炎球菌多糖疫苗加强注射有快速的免疫反应。接受一剂已获许可的肺炎球菌多糖疫苗初次注射的对照婴儿，对七种血清型中的四种免疫反应可忽略不计，对其他三种血清型反应较低。
给小婴儿接种的试验性七价肺炎球菌结合疫苗耐受性良好且具有高度免疫原性，并为注射已获许可的肺炎球菌多糖疫苗提供了免疫记忆。
