Safety, tolerability and immunogenicity of GS-4774, a hepatitis B virus-specific therapeutic vaccine, in healthy subjects: A randomized study

• Published in: Vaccine Vol. 32; no. 39; pp. 4925 - 4931
• Main Authors: Gaggar, Anuj, Coeshott, Claire, Apelian, David, Rodell, Timothy, Armstrong, Brian R., Shen, Gong, Subramanian, G. Mani, McHutchison, John G.
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 03.09.2014; Elsevier; Elsevier Limited
• Subjects: Adult; Aged; Allergy and Immunology; Amino acids; Applied microbiology; Biological and medical sciences; Drug therapy; Female; Fundamental and applied biological sciences. Psychology; GS-4774; HBV; Healthy subjects; Healthy Volunteers; Hepatitis; hepatitis B; Hepatitis B Antibodies - blood; Hepatitis B Vaccines - adverse effects; Hepatitis B Vaccines - immunology; Hepatitis B Vaccines - therapeutic use; Hepatitis B virus; Hepatitis B, Chronic - therapy; Humans; immune response; Immunity, Cellular; Immunization; Immunization, Secondary; Immunogenicity; Immunotherapy; Infections; Injection; injection site; interferon-gamma; Interferon-gamma - immunology; Laboratories; lymphocyte proliferation; Lymphocytes; Male; Microbiology; Middle Aged; Miscellaneous; patients; Peptides; recombinant antigens; Saccharomyces cerevisiae; T-lymphocytes; T-Lymphocytes - immunology; Vaccine; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Vaccines, Synthetic - therapeutic use; Virology; Yeast; Yeasts; Young Adult; Healthy subjects; Vaccine; HBV; GS-4774; Hepatitis A virus; Picornaviridae; Orthohepadnavirus; Hepatovirus; Virus; Immunogenicity; Hepadnaviridae; Immunotherapy; Hepatitis B virus

•GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection.•GS-4774 consists of yeast cells that express well-conserved regions of HBV proteins.•GS-4774 was safe and well-tolerated in healthy subjects at all doses evaluated.•GS-4774 led to HBV-specific immune responses after week...