Evaluation of safety and efficacy as an adjuvant for the chitosan-based vaccine delivery vehicle ViscoGel in a single-blind randomised Phase I/IIa clinical trial

• Published in: Vaccine 2014-10, Vol.32 (45), p.5967-5974
• Main Authors: Neimert-Andersson, Theresa, Binnmyr, Jonas, Enoksson, Mattias, Langebäck, Joakim, Zettergren, Louise, Hällgren, Anne-Charlotte, Franzén, Henry, Lind Enoksson, Sara, Lafolie, Pierre, Lindberg, Alf, Al-Tawil, Nabil, Andersson, Mats, Singer, Peter, Grönlund, Hans, Gafvelin, Guro
• Format: Article
• Language: English
• Subjects: Adjuvant; Adjuvants, Immunologic - adverse effects; Adjuvants, Immunologic - pharmacology; Adult; Allergy and Immunology; Antibodies, Bacterial - blood; Antigens; Applied microbiology; Bacteriology; Biological and medical sciences; Chitosan; Chitosan - chemistry; Clinical trial; Clinical trials; Drug dosages; Female; Fundamental and applied biological sciences. Psychology; Good Manufacturing Practice; Haemophilus Infections - prevention & control; Haemophilus influenzae type B; Haemophilus Vaccines - therapeutic use; Humans; Hydrogels; Hydrogels - adverse effects; Hydrogels - pharmacology; Immunity, Cellular; Injection; Interferon-gamma - immunology; Male; Medicin och hälsovetenskap; Microbiology; Middle Aged; Miscellaneous; Particle size; Safety engineering; Single-Blind Method; Vaccine; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Conjugate - therapeutic use; Young Adult
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2014.08.057

Highlights • ViscoGel is safe and well tolerated after one intramuscular injection in man. • ViscoGel impacts on the cell-mediated response to the model vaccine Act-HIB. • ViscoGel prevents an Act-HIB induced inhibition of an IFN-γ response. • Act-HIB + ViscoGel induces similar antibody responses as Act-HIB alone.