Malaria Research and Training Center, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako, P,O, Box 1805, Bamako, Mali.
BMC Public Health. 2011 Nov 23;11:882. doi: 10.1186/1471-2458-11-882.
Pneumonia is still the leading cause of death among children in Africa, and pneumococcal serotypes 1 and 5 are frequently isolated from African children with invasive pneumococcal disease below the age of 5 years. The immunogenicity, safety and reactogenicity of 3-dose primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in infants in Mali and Nigeria.
In an open, randomized, controlled study, 357 infants received DTPw-HBV/Hib and OPV primary vaccination with (PHiD-CV group) or without (control group) PHiD-CV co-administration at 6, 10 and 14 weeks of age. Pneumococcal antibody responses and opsonophagocytic activity (OPA) were measured and adverse events (AEs) recorded.
One month post-dose 3, ≥ 97.2% of PHiD-CV-vaccinated infants had an antibody concentration ≥ 0.2 μg/mL for each vaccine pneumococcal serotype except for 6B (82.0%) and 23F (87.6%) versus < 10% in the control group except for serotypes 14 (35.7%) and 19F (22.5%). For each vaccine serotype, ≥ 93.3% of PHiD-CV recipients had an OPA titre ≥ 8, except for serotypes 1 (87.6%) and 6B (85.4%), compared to < 10% in the control group, except for serotypes 7F (42.9%), 9V (24.1%) and 14 (24.5%). Anti-protein D geometric mean antibody concentrations were 3791.8 and 85.4 EL.U/mL in the PHiD-CV and control groups, respectively. Overall incidences of solicited and unsolicited AEs were similar between groups.
In sub-Saharan African infants, PHiD-CV was immunogenic for all vaccine pneumococcal serotypes and protein D. Vaccine tolerability was generally comparable between the PHiD-CV and control groups.
ClinicalTrials.gov identifier: NCT00678301.
肺炎仍然是非洲儿童死亡的主要原因，在 5 岁以下患有侵袭性肺炎球菌病的非洲儿童中，经常分离到血清型 1 和 5 的肺炎球菌。在马里和尼日利亚的婴儿中评估了三剂原发性接种 10 价肺炎球菌无型流感嗜血杆菌蛋白 D 结合疫苗（PHiD-CV）的免疫原性、安全性和反应原性。
在一项开放、随机、对照研究中，357 名婴儿在 6、10 和 14 周龄时接受 DTPw-HBV/Hib 和 OPV 基础免疫接种，同时给予（PHiD-CV 组）或不给予（对照组）PHiD-CV 联合接种。测量肺炎球菌抗体反应和调理吞噬活性（OPA），并记录不良事件（AE）。
在第 3 剂后 1 个月，≥97.2%的 PHiD-CV 疫苗接种婴儿的每种疫苗肺炎球菌血清型的抗体浓度≥0.2μg/mL，除 6B（82.0%）和 23F（87.6%）外，对照组中每种疫苗血清型的抗体浓度均<10%，除血清型 14（35.7%）和 19F（22.5%）外。对于每种疫苗血清型，≥93.3%的 PHiD-CV 受种者的 OPA 滴度≥8，除血清型 1（87.6%）和 6B（85.4%）外，对照组中每种疫苗血清型的 OPA 滴度均<10%，除血清型 7F（42.9%）、9V（24.1%）和 14（24.5%）外。PHiD-CV 和对照组的抗蛋白 D 几何平均抗体浓度分别为 3791.8 和 85.4 EL.U/mL。两组间的一般不良事件的发生率相似。
在撒哈拉以南非洲婴儿中，PHiD-CV 对所有疫苗肺炎球菌血清型和蛋白 D 均具有免疫原性。疫苗的耐受性在 PHiD-CV 组和对照组之间总体上相当。
ClinicalTrials.gov 标识符：NCT00678301。
