Department of Science and Technology, University of Witwatersrand, Johannesburg, South Africa.
S Afr Med J. 2011 Nov 28;101(12):879-83.
To assess the immunogenicity and safety of a pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Hib polysaccharide-conjugate vaccine booster.
DESIGN, SETTING AND PARTICIPANTS: A DTaP-IPV//PRP~T vaccine (Pentaxim, a Sanofi Pasteur AcXim family vaccine) was given to 182 healthy children in South Africa at 18 - 19 months of age following priming with the same vaccine plus a monovalent hepatitis B vaccine at 6, 10 and 14 weeks of age. Outcome measures. Seroprotection (SP) and seroconversion (SC) rates, geometric mean titres (GMTs) and concentrations (GMCs) were assessed before, and 1 month after, the booster dose. Safety was assessed using parental reports.
One month after primary vaccination, at least 94.3% of participants were seroprotected against tetanus (≥ 0.01 IU/ml), diphtheria (≥ 0.01 IU/ml), poliovirus (≥ 8 1/dil) and Haemophilus influenzae type b (Hib) infection (≥ 0.15 µg/ml). Before the booster dose, the SP rates ranged from 65.7% to 100%. One month after the booster dose, SP rates were 97.7% for Hib (anti-PRP titre 1.0 μg/ml), 100.0% for diphtheria (≥ 0.1 IU/ml) and 100% for tetanus (≥ 0.1 IU/ml) and poliovirus types 1, 2, 3 (≥ 8 1/dil). At least 95.7% of participants had 4 fold post-booster increases in anti-pertussis antibody titres. GMTs increased from 11.21 to 465.51 EU/ml and from 12.89 to 520.35 EU/ml for anti-PT and anti-FHA respectively. Anti-PRP GMT increased from 0.35 to 47.01 μg/ml. The DTaP-IPV//PRP~T vaccine booster was well tolerated, with fever ≥ 39.0°C in only 1.7% of participants.
Antibody persistence following priming was satisfactory. The pentavalent DTaP-IPV//PRP~T vaccine booster was highly immunogenic and well tolerated.
评估五价白喉、破伤风、无细胞百日咳、灭活脊髓灰质炎、b 型流感嗜血杆菌多糖结合疫苗加强剂的免疫原性和安全性。
设计、地点和参与者：在南非，182 名健康儿童在 18-19 个月龄时，在接受过同样的疫苗加单剂乙型肝炎疫苗（6、10 和 14 周龄）接种后，接种了 DTaP-IPV//PRP~T 疫苗（Pentaxim，赛诺菲巴斯德公司的 AcXim 系列疫苗）。结果测量。在加强剂量之前和之后 1 个月，评估血清保护率（SP）和血清转化率（SC）率、几何平均滴度（GMT）和浓度（GMC）。使用父母报告评估安全性。
在初次接种后 1 个月，至少 94.3%的参与者对破伤风（≥0.01IU/ml）、白喉（≥0.01IU/ml）、脊髓灰质炎（≥81/dil）和 b 型流感嗜血杆菌（Hib）感染（≥0.15μg/ml）具有血清保护。在加强剂量前，血清保护率范围为 65.7%至 100%。在加强剂量后 1 个月，Hib 的血清保护率为 97.7%（抗 PRP 效价为 1.0μg/ml），白喉为 100.0%（≥0.1IU/ml），破伤风为 100.0%（≥0.1IU/ml），脊髓灰质炎 1 型、2 型、3 型（≥81/dil）。至少 95.7%的参与者在加强后抗百日咳抗体滴度增加了 4 倍。GMT 分别从 11.21 增加到 465.51EU/ml 和从 12.89 增加到 520.35EU/ml，用于抗-PT 和抗-FHA。抗-PRP GMT 从 0.35 增加到 47.01μg/ml。五价 DTaP-IPV//PRP~T 疫苗加强剂具有良好的耐受性，只有 1.7%的参与者发热≥39.0°C。
初次接种后的抗体持续时间令人满意。五价 DTaP-IPV//PRP~T 疫苗加强剂具有高度的免疫原性和良好的耐受性。
