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

• Published in: Vaccine Vol. 32; no. 39; pp. 5041 - 5048
• Main Authors: 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: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 03-09-2014; Elsevier; Elsevier Limited
• Subjects: 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; Singapore; USA, California; hemagglutination inhibition; ribonucleic acid; medical dictionary for regulatory authorities; RNA; hemagglutinin; sodium dodecyl sulfate-polyacrylamide gel electrophoresis; Pandemic; cGMP; MHC; major histocompatibility complex; current good manufacturing practices; VLP; Influenza vaccine; Asians; AE; SE-HPLC; MedDRA; adverse event; H1N1; HAI; SDS-PAGE; Virus-like particle; size exclusion high-performance liquid chromatography; Phase I; Influenza; HA; Virus like particle; Orthomyxoviridae; Vaccine; Infection; Virus; Influenzavirus A; Immunogenicity; Influenza A virus; Viral disease; Phase I trial; Influenzavirus A(H1N1)
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2014.07.011

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.