Reactogenicity, safety and immunogenicity of a protein-based pneumococcal vaccine in Gambian children aged 2–4 years: A phase II randomized study
| Autor: | Martin O. C. Ota, Archibald Worwui, Aderonke Odutola, Patrick K. Owiafe, Brian Greenwood, Kurt Dobbelaere, Magali Traskine, Ezra O. Ogundare, Vincent Verlant, Dorota Borys, Martin Antonio, Mark R. Alderson |
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| Rok vydání: | 2015 |
| Předmět: |
safety
Male 0301 basic medicine pneumococcal vaccine Hydrolases pneumococcal protein Immunology immunogenicity medicine.disease_cause Pneumococcal Infections Pneumococcal Vaccines 03 medical and health sciences 0302 clinical medicine Bacterial Proteins Streptococcus pneumoniae medicine Humans Immunology and Allergy 030212 general & internal medicine Pharmacology Vaccines Conjugate Pneumolysin Reactogenicity business.industry Immunogenicity Vaccination Toxoid medicine.disease Research Papers Antibodies Bacterial Virology Gambian children Pneumococcal infections 030104 developmental biology Pneumococcal vaccine Child Preschool Streptolysins Female Gambia business |
| Zdroj: | Human Vaccines & Immunotherapeutics |
| ISSN: | 2164-554X 2164-5515 |
| DOI: | 10.1080/21645515.2015.1111496 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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