Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine: Results from a double-blinded, randomized Phase I clinical trial in healthy Asian volunteers

Highlights • Phase I clinical trial with a novel VLP influenza vaccine produced in E. coli. • Randomized study with/without alhydrogel, total of 84 subjects. • Vaccine safe and well tolerated. • Vaccine (non-adjuvanted) met all primary and secondary endpoints. • Proof-of-concept for Qbeta VLP as pro...

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Veröffentlicht in:	Vaccine 2014-09, Vol.32 (39), p.5041-5048
Hauptverfasser:	Low, Jenny G.H, Lee, Lawrence S, Ooi, Eng Eong, Ethirajulu, Kantharaj, Yeo, Pauline, Matter, Alex, Connolly, John E, Skibinski, David A.G, Saudan, Philippe, Bachmann, Martin, Hanson, Brendon J, Lu, Qingshu, Maurer-Stroh, Sebastian, Lim, Sam, Novotny-Diermayr, Veronica
Format:	Artikel
Sprache:	eng
Schlagworte:	Adjuvants, Immunologic - administration & dosage Adult Allergy and Immunology Aluminum Hydroxide - administration & dosage Amino acids Antibodies, Viral - blood Antibody Formation Antigens Applied microbiology Asians Biological and medical sciences Clinical trials Double-Blind Method E coli Endpoint Determination Female Fundamental and applied biological sciences. Psychology Glycerol H1N1 HAI Hemagglutination Inhibition Tests Humans Immunization Immunogenicity Influenza Influenza A Virus, H1N1 Subtype Influenza vaccine Influenza Vaccines - therapeutic use Influenza, Human - prevention & control Male Microbiology Middle Aged Miscellaneous Pandemic Pandemics Pharmaceutical industry Phase I Proteins Safety Singapore Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Virus-Like Particle - therapeutic use Virology Virus-like particle VLP Young Adult
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Beschreibung
Zusammenfassung:	Highlights • Phase I clinical trial with a novel VLP influenza vaccine produced in E. coli. • Randomized study with/without alhydrogel, total of 84 subjects. • Vaccine safe and well tolerated. • Vaccine (non-adjuvanted) met all primary and secondary endpoints. • Proof-of-concept for Qbeta VLP as prophylactic vaccine.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2014.07.011