Safety and immunogenicity of the novel H4:IC31 tuberculosis vaccine candidate in BCG-vaccinated adults: Two phase I dose escalation trials

Highlights • H4:IC31 vaccination was well tolerated with an acceptable safety profile. • H4:IC31 vaccination elicited persistent antigen-specific CD4+ T cell responses. • H4:IC31 triggered T cell expansion, IFNγ production and multifunctional Th1 cells. • Optimal antigen-adjuvant doses were 5, 15, o...

Ausführliche Beschreibung

Gespeichert in:

Bibliographische Detailangaben
Veröffentlicht in:	Vaccine 2017-03, Vol.35 (12), p.1652-1661
Hauptverfasser:	Norrby, Maria, Vesikari, Timo, Lindqvist, Lars, Maeurer, Markus, Ahmed, Raija, Mahdavifar, Shahnaz, Bennett, Sean, McClain, J. Bruce, Shepherd, Barbara M, Li, Daner, Hokey, David A, Kromann, Ingrid, Hoff, Søren T, Andersen, Peter, de Visser, Adriëtte W, Joosten, Simone A, Ottenhoff, Tom H.M, Andersson, Jan, Brighenti, Susanna
Format:	Artikel
Sprache:	eng
Schlagworte:	Acyltransferases - administration & dosage Acyltransferases - adverse effects Acyltransferases - immunology Adult Allergy and Immunology Antigens Antigens, Bacterial - administration & dosage Antigens, Bacterial - adverse effects Antigens, Bacterial - immunology Bacterial Proteins - administration & dosage Bacterial Proteins - adverse effects Bacterial Proteins - immunology CD4-Positive T-Lymphocytes - immunology Clinical trial Clinical trials Double-Blind Method Drug Combinations Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - pathology Family medical history Finland Health care Healthy Volunteers Human Humans Immunity Immunization Immunogenicity Injection Mycobacterium Neutrophils Oligodeoxyribonucleotides - administration & dosage Oligodeoxyribonucleotides - adverse effects Oligopeptides - administration & dosage Oligopeptides - adverse effects Placebos - administration & dosage Proteins Safety Studies Sweden Treatment Outcome Tuberculosis Tuberculosis - prevention & control Tuberculosis Vaccines - administration & dosage Tuberculosis Vaccines - adverse effects Tuberculosis Vaccines - immunology Urine Vaccine Vaccines
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!

Beschreibung
Zusammenfassung:	Highlights • H4:IC31 vaccination was well tolerated with an acceptable safety profile. • H4:IC31 vaccination elicited persistent antigen-specific CD4+ T cell responses. • H4:IC31 triggered T cell expansion, IFNγ production and multifunctional Th1 cells. • Optimal antigen-adjuvant doses were 5, 15, or 50 μg of H4 plus 500 nmol of IC31.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2017.01.055