Mom to baby ID connection in Safety and Immunogenicity of Anti-pneumococcal Vaccines in HIV-infected Pregnant Women

The connection between the mother ID and the baby ID
Study Description
NICHD P1091 was a multi-center, Phase II, randomized, double-blinded, placebo-controlled study of HIV-infected pregnant women on HAART who were in the second or third trimester of pregnancy and of their infants. The study was designed to investigate the safety, reactogenicity, immunogenicity, transplacental antibody transfer, and interference with infant responses to childhood vaccination of maternal vaccination with PCV-10 or PPV-23 by comparison with placebo. Mothers were randomized to receive PCV-10, PPV-23, or placebo in a blinded fashion. They were followed for safety, immunogenicity, and vaccine-specific anti-capsular pneumococcus (PNC) antibody persistence until 24 weeks post-delivery. Women who received placebo were randomized to a second study step and received PCV-10 or PPV-23 at 24 weeks post-delivery. Antibody responses to the vaccine administered 6 months postpartum were measured. All infants received PCV-10 vaccinations per local standard of care. HIV-infected pregnant women on HAART who were in the second or third trimester of pregnancy, with their infants.

母亲标识符与婴儿标识符关联研究

研究概况
NICHD P1091是一项多中心II期随机双盲安慰剂对照临床试验，研究对象为妊娠中晚期且接受高效抗反转录病毒治疗（Highly Active Antiretroviral Therapy，HAART）的HIV感染孕妇及其所分娩的婴儿。本研究旨在对比接种10价肺炎球菌结合疫苗（PCV-10）、23价肺炎球菌多糖疫苗（PPV-23）与安慰剂的孕妇，评估其接种后的安全性、反应原性、免疫原性、胎盘抗体转运情况，以及对婴儿儿童期疫苗接种应答的干扰效应。
受试者采用盲法随机分配至PCV-10组、PPV-23组或安慰剂组。研究人员对受试者进行随访至分娩后24周，以评估疫苗相关安全性、免疫原性及肺炎球菌荚膜抗体（PNC）的持久性。接受安慰剂干预的孕妇将进入第二研究阶段，于分娩后24周随机接种PCV-10或PPV-23，并检测其产后6个月接种疫苗后的抗体应答水平。所有婴儿均按照当地标准护理流程接种PCV-10疫苗。本研究纳入的受试者为妊娠中晚期且接受HAART治疗的HIV感染孕妇及其所分娩的婴儿。