Phadke M A, Kulkarni M V, Sovani V B, Lokeshwar M R, Venkataraman R
Department of Pediatrics, B.J. Medical College, Pune.
Indian Pediatr. 1997 Sep;34(9):779-83.
To assess the immunogenicity in Indian infants to Haemophilus influenzae b oligosaccharide conjugate vaccine (HbOC).
Prospective multicenter study.
Pediatric Out Patient Department of general hospitals in Pune and Mumbai.
124 full term healthy infants brought for routine DPT/OPV immunization.
Infants were administered 3 doses of 0.5 ml of HbOC, on the same day as their DPT/OPV immunization, injected intramuscularly on the limb opposite to that where DPT vaccine was administered. Data on local reactions and general symptoms was collected for three days after every dose. The children had their blood collected for assay of anti PRP (polyribosil ribitol phosphate) antibody titers, along with the first injection and one month after the third injection. One hundred and three infants completed the study protocol with two blood collections.
The initial geometric mean titers (GMT) of 0.124 mcg/ml rose by 37 times to 4.552 mcg/ml. Ninety eight children (95.1%) had a final titer of > or = 0.15 mcg/ml, the minimum level associated with protection, and 77 children (74.8%) had a final level of > or = 1.0 mcg/ml, a level associated with long term protection.
HbOC is immunogenic in Indian infants when used as per the locally recommended DPT/OPV immunization schedule.
评估b型流感嗜血杆菌寡糖结合疫苗（HbOC）在印度婴儿中的免疫原性。
前瞻性多中心研究。
浦那和孟买综合医院的儿科门诊部。
124名前来进行常规白喉-百日咳-破伤风疫苗/口服脊髓灰质炎疫苗免疫接种的足月健康婴儿。
在婴儿接种白喉-百日咳-破伤风疫苗/口服脊髓灰质炎疫苗的同一天，给婴儿肌内注射3剂0.5毫升HbOC，注射部位在接种白喉-百日咳-破伤风疫苗肢体的对侧。每剂接种后三天收集局部反应和一般症状的数据。在首次注射时以及第三次注射后一个月采集儿童血液，用于检测抗PRP（多核糖基核糖醇磷酸）抗体滴度。103名婴儿完成了两次血液采集的研究方案。
初始几何平均滴度（GMT）为0.124微克/毫升，上升了37倍，达到4.552微克/毫升。98名儿童（95.1%）的最终滴度≥0.15微克/毫升，这是与保护相关的最低水平，77名儿童（74.8%）的最终水平≥1.0微克/毫升，这是与长期保护相关的水平。
按照当地推荐的白喉-百日咳-破伤风疫苗/口服脊髓灰质炎疫苗免疫接种程序使用时，HbOC在印度婴儿中具有免疫原性。
