Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1

Highlights • We performed the first in man study with a live replication-deficient delNS1-trivalent vaccine. • Significant antibody titers to influenza strains contained in the vaccine were induced. • Seroconversion occurred most frequently in participants who were seronegative before vaccination. •...

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Veröffentlicht in:	Vaccine 2013-12, Vol.31 (52), p.6194-6200
Hauptverfasser:	Mössler, Christina, Groiss, Franz, Wolzt, Michael, Wolschek, Markus, Seipelt, Joachim, Muster, Thomas
Format:	Artikel
Sprache:	eng
Schlagworte:	Administration, Intranasal Adolescent Adult adults Allergy and Immunology antibodies Antibodies, Viral - blood Applied microbiology Biological and medical sciences Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - pathology Female Fundamental and applied biological sciences. Psychology Good Manufacturing Practice headache Healthy Volunteers Humans Immune response Immunization Immunogenicity Influenza Influenza A Virus, H1N1 Subtype - genetics Influenza A Virus, H1N1 Subtype - immunology Influenza A Virus, H3N2 Subtype - genetics Influenza A Virus, H3N2 Subtype - immunology Influenza B virus - genetics Influenza B virus - immunology Influenza Vaccines - administration & dosage Influenza Vaccines - adverse effects Influenza Vaccines - immunology Influenza virus Intranasal Live-attenuated Male Microbiology Miscellaneous NS1 Orthomyxoviridae Placebos - administration & dosage Reverse genetics Rhinitis seroprevalence Trivalent vaccination Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Attenuated - administration & dosage Vaccines, Attenuated - immunology Viral infections Viral Nonstructural Proteins - deficiency Virology
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Beschreibung
Zusammenfassung:	Highlights • We performed the first in man study with a live replication-deficient delNS1-trivalent vaccine. • Significant antibody titers to influenza strains contained in the vaccine were induced. • Seroconversion occurred most frequently in participants who were seronegative before vaccination. • A single intranasal dose was well tolerated and safe in healthy male and female participants. • No vaccine virus could be re-isolated in volunteers after immunization.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2013.10.061