Odutola A, Ota M O, Ogundare E O, Antonio M, Owiafe P, Worwui A, Greenwood B, Alderson M, Traskine M, Verlant V, Dobbelaere K, Borys D
a Medical Research Council Unit ; Banjul , The Gambia.
b London School of Hygiene & Tropical Medicine ; London , UK.
Hum Vaccin Immunother. 2016;12(2):393-402. doi: 10.1080/21645515.2015.1111496.
Pneumococcal conjugate vaccines (PCVs) have been successful in preventing invasive pneumococcal disease but effectiveness has been challenged by replacement of vaccine serotypes with non-vaccine serotypes. Vaccines targeting common pneumococcal protein(s) found in most/all pneumococci may overcome this limitation. This phase II study assessed safety and immunogenicity of a new protein-based pneumococcal vaccine containing polysaccharide conjugates of 10 pneumococcal serotypes combined with pneumolysin toxoid(dPly) and pneumococcal histidine triad protein D(PhtD) (PHiD-CV/dPly/PhtD-30) in African children. 120 Gambian children (2-4 years, not previously vaccinated against Streptococcus pneumoniae) randomized (1:1) received a single dose of PHiD-CV/dPly/PhtD-30 or PCV13. Adverse events occurring over 4 d post-vaccination were reported, and blood samples obtained pre- and 1-month post-vaccination. Serious adverse events were reported for 6 months post-vaccination. Solicited local and systemic adverse events were reported at similar frequency in each group. One child (PHiD-CV/dPly/PhtD-30 group) reported a grade 3 local reaction to vaccination. Haematological and biochemical parameters seemed similar pre- and 1-month post-vaccination in each group. High pre-vaccination Ply and PhtD antibody concentrations were observed in each group, but only increased in PHiD-CV/dPly/PhtD-30 vaccinees one month post-vaccination. One month post-vaccination, for each vaccine serotype ≥96.2% of PHiD-CV/dPly/PhtD-30 vaccinees had serotype-specific polysaccharide antibody concentrations ≥0.20µg/mL except serotypes 6B (80.8%) and 23F (65.4%), and ≥94.1% had OPA titres of ≥8 except serotypes 1 (51.9%), 5 (38.5%) and 6B (78.0%), within ranges seen in PCV13-vaccinated children. A single dose of PHiD-CV/dPly/PhtD-30 vaccine, administered to Gambian children aged 2-4 y not previously vaccinated with a pneumococcal vaccine, was well-tolerated and immunogenic.
肺炎球菌结合疫苗（PCV）已成功预防侵袭性肺炎球菌疾病，但疫苗血清型被非疫苗血清型取代对其有效性构成了挑战。针对大多数/所有肺炎球菌中常见的肺炎球菌蛋白的疫苗可能会克服这一局限性。这项II期研究评估了一种新的基于蛋白的肺炎球菌疫苗的安全性和免疫原性，该疫苗含有10种肺炎球菌血清型的多糖结合物，与肺炎溶素类毒素（dPly）和肺炎球菌组氨酸三联体蛋白D（PhtD）（PHiD-CV/dPly/PhtD-30）联合使用，用于非洲儿童。120名冈比亚儿童（2至4岁，以前未接种过肺炎链球菌疫苗）随机分组（1:1），分别接受一剂PHiD-CV/dPly/PhtD-30或PCV13。报告了接种疫苗后4天内发生的不良事件，并在接种前和接种后1个月采集血样。报告了接种疫苗后6个月内的严重不良事件。每组中，局部和全身主动报告的不良事件发生率相似。一名儿童（PHiD-CV/dPly/PhtD-30组）报告了3级疫苗接种局部反应。每组接种前和接种后1个月的血液学和生化参数似乎相似。每组接种前Ply和PhtD抗体浓度较高，但仅在接种PHiD-CV/dPly/PhtD-30疫苗的儿童接种后1个月有所增加。接种后1个月，对于每种疫苗血清型，除6B血清型（80.8%）和23F血清型（65.4%）外，≥96.2%的接种PHiD-CV/dPly/PhtD-30疫苗的儿童血清型特异性多糖抗体浓度≥0.20µg/mL，除1血清型（51.9%）、5血清型（38.5%）和6B血清型（78.0%）外，≥94.1%的儿童OPA滴度≥8，这些范围与接种PCV13的儿童相似。对2至4岁、以前未接种过肺炎球菌疫苗的冈比亚儿童接种一剂PHiD-CV/dPly/PhtD-30疫苗后，耐受性良好且具有免疫原性。
