Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial
Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial
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DOI：
10.1186/1471-2458-11-882
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发表时间：
2011-11-23
影响因子：
4.5
通讯作者：
Schuerman, Lode
中科院分区：
文献类型：
--
作者：
Dicko, Alassane;Odusanya, Olumuyiwa O.;Schuerman, Lode
背景资料：肺炎仍然是非洲儿童死亡的主要原因，肺炎球菌血清型1和5经常从5岁以下患有侵袭性肺炎球菌疾病的非洲儿童中分离出来。在马里和尼日利亚的婴儿中评估了10价肺炎球菌不可分型流感嗜血杆菌蛋白D结合疫苗（PHiD-CV）3剂初次接种的免疫原性、安全性和反应原性。方法：在一项开放、随机、对照研究中，357名婴儿接受了DTPW-HBV/Hib和OPV初次接种，在6周龄、10周龄和14周龄时，在没有PHiD-CV共同施用的情况下（PHiD-CV组）或没有（对照组）PHiD-CV共同施用的情况下进行。测量肺炎球菌抗体应答和调理吞噬活性（OPA）并记录不良事件（AE）。第3次给药后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抗体浓度>= 0.2 μ g/mL，6 B除外血清型14（35.7%）和19 F（22.5%）除外，对照组中血清型23（82.0%）和23 F（87.6%）与< 10%相比。对于每种疫苗血清型，除了血清型1（87.6%）和6 B（85.4%）之外，>= 93.3%的PHiD-CV接受者具有>= 8的OPA滴度，相比之下，对照组中除了血清型7 F（42.9%）、9V（24.1%）和14（24.5%）之外，OPA滴度< 10%。PHiD-CV组和对照组的抗蛋白D几何平均抗体浓度分别为3791.8和85.4 EL.U/mL。组间征集性和非征集性AE的总体发生率相似。结论：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具有免疫原性。PHiD-CV和对照组之间的疫苗耐受性通常相当。
Background: 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.Methods: 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.Results: One month post-dose 3, >= 97.2% of PHiD-CV-vaccinated infants had an antibody concentration >= 0.2 mu g/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.Conclusions: 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.