Safety, reactogenicity and immunogenicity of a novel pneumococcal protein-based vaccine in adults: A phase I/II randomized clinical study

Highlights • First safety study of six novel pneumococcal protein-containing vaccine formulations. • Formulations contained dPly alone or dPly and PhtD, alone or with 10 PS-conjugates. • All formulations used as two- or three-dose series in healthy adults were well-tolerated. • All formulations were...

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Veröffentlicht in:	Vaccine 2014-11, Vol.32 (50), p.6838-6846
Hauptverfasser:	Leroux-Roels, Geert, Maes, Cathy, De Boever, Fien, Traskine, Magali, Rüggeberg, Jens U, Borys, Dorota
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Adult Allergy and Immunology Antibodies, Bacterial - blood Antigens Applied microbiology Bacterial Proteins - immunology Bacteriology Biological and medical sciences Confidence intervals Double-Blind Method dPly Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - pathology Female Fundamental and applied biological sciences. Psychology Haemophilus influenzae Healthy Volunteers Humans Hydrolases - immunology Immunization Immunogenicity Male Microbiology Miscellaneous PhtD Placebos - administration & dosage Pneumococcal protein-containing vaccine Pneumococcal Vaccines - administration & dosage Pneumococcal Vaccines - adverse effects Pneumococcal Vaccines - immunology Pneumolysin Pneumonia Proteins Saccharides Streptococcus infections Streptococcus pneumoniae Streptococcus pneumoniae - immunology Streptolysins - immunology Studies Vaccination - adverse effects Vaccination - methods Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Young Adult
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Zusammenfassung:	Highlights • First safety study of six novel pneumococcal protein-containing vaccine formulations. • Formulations contained dPly alone or dPly and PhtD, alone or with 10 PS-conjugates. • All formulations used as two- or three-dose series in healthy adults were well-tolerated. • All formulations were immunogenic for protein antigens. • PS-conjugate-containing formulations were also immunogenic for the PS-conjugates.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2014.02.052