Baker Carol J, Rench Marcia A, McInnes Pamela
Departments of Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
Vaccine. 2003 Jul 28;21(24):3468-72. doi: 10.1016/s0264-410x(03)00353-0.
To determine the safety and immunogenicity of group B streptococcal (GBS) type III CPS-TT conjugate vaccine in pregnant women.
Prospective, randomized (2:1, vaccine:placebo), double-blind, placebo-controlled trial in women at 30-32 weeks' gestation and their infants. Immune responses were measured with IgG-specific ELISA assays; killing of III GBS by 1- and 2-month infant sera was assessed by opsonophagocytosis.
Immunization was well-tolerated; maternal and infant outcomes were similar in vaccine and placebo groups. III-TT conjugate elicited good levels of IgG to III CPS that were functionally active against type III GBS through age 2 months.
Maternal immunization with GBS CPS-TT conjugates could prevent maternal, neonatal and young infant GBS disease.
确定B族链球菌（GBS）Ⅲ型结合多糖-破伤风类毒素（CPS-TT）疫苗在孕妇中的安全性和免疫原性。
对妊娠30 - 32周的妇女及其婴儿进行前瞻性、随机（2:1，疫苗:安慰剂）、双盲、安慰剂对照试验。用IgG特异性ELISA检测免疫反应；通过调理吞噬作用评估1个月和2个月婴儿血清对Ⅲ型GBS的杀伤作用。
免疫接种耐受性良好；疫苗组和安慰剂组的母婴结局相似。Ⅲ-TT结合物诱导产生了高水平的针对Ⅲ型CPS的IgG，在2个月龄前对Ⅲ型GBS具有功能活性。
孕妇接种GBS CPS-TT结合物可预防孕妇、新生儿和幼儿的GBS疾病。
