Safety, tolerability and immunogenicity of GS-4774, a hepatitis B virus-specific therapeutic vaccine, in healthy subjects: A randomized study
•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...
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| Published in | Vaccine Vol. 32; no. 39; pp. 4925 - 4931 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Kidlington
Elsevier Ltd
03.09.2014
Elsevier Elsevier Limited |
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| Abstract | •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 weekly and monthly immunization.•GS-4774 is being tested in patients with chronic HBV infection.
GS-4774 is a recombinant, heat-killed, yeast-based immunotherapy engineered to express hepatitis B virus (HBV)-specific antigens. GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection. The aim of this study was to assess the safety, tolerability and immunogenicity of GS-4774 in healthy subjects.
This was a randomized, open-label, dose-ascending study. Subjects were allocated to one of three dose groups (n=20 per group) to receive 10, 40 or 80 yeast units (YU; 1YU=107 yeast) of GS-4774 in two immunization regimens (five subcutaneous injections at weekly intervals with one monthly booster or three subcutaneous injections at monthly intervals). T-cell-mediated responses were determined by interferon (IFN)-γ enzyme-linked immunospot (ELISpot) assay and lymphocyte-proliferation assay (LPA).
Adverse events were reported by 39 of 60 (65%) subjects; all were mild or moderate and none was serious. Adverse events occurred most frequently in the highest dose group, 80YU, and the number of individual events was higher after weekly immunization than monthly. The most common adverse events were injection-site reactions. Most (88%) subjects responded to GS-4774 by at least one of the T-cell assays. Following immunization with GS-4774, IFN-γ-producing T-cells specific for HBV antigens were detectable in 30 (51%) subjects. The ELISpot response was observed at all doses, with the highest frequency of responders occurring at the highest dose (10YU: 45%; 40YU: 35%; 80YU: 74%). Proliferative responses to HBV recombinant antigens were observed in 90% subjects; responses were mainly independent of GS-4774 dose and immunization regimen.
GS-4774 was safe and well-tolerated in healthy subjects with injection-site reactions being the most frequently reported adverse events. With both weekly and monthly regimens, GS-4774 provided HBV-specific immune responses at all doses evaluated. Further evaluation of GS-4774 is ongoing in patients with chronic HBV infection.
Clinical trial registry: Clinicaltrials.gov (NCT01779505) |
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| AbstractList | Highlights•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 weekly and monthly immunization. •GS-4774 is being tested in patients with chronic HBV infection. •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 weekly and monthly immunization.•GS-4774 is being tested in patients with chronic HBV infection. GS-4774 is a recombinant, heat-killed, yeast-based immunotherapy engineered to express hepatitis B virus (HBV)-specific antigens. GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection. The aim of this study was to assess the safety, tolerability and immunogenicity of GS-4774 in healthy subjects. This was a randomized, open-label, dose-ascending study. Subjects were allocated to one of three dose groups (n=20 per group) to receive 10, 40 or 80 yeast units (YU; 1YU=107 yeast) of GS-4774 in two immunization regimens (five subcutaneous injections at weekly intervals with one monthly booster or three subcutaneous injections at monthly intervals). T-cell-mediated responses were determined by interferon (IFN)-γ enzyme-linked immunospot (ELISpot) assay and lymphocyte-proliferation assay (LPA). Adverse events were reported by 39 of 60 (65%) subjects; all were mild or moderate and none was serious. Adverse events occurred most frequently in the highest dose group, 80YU, and the number of individual events was higher after weekly immunization than monthly. The most common adverse events were injection-site reactions. Most (88%) subjects responded to GS-4774 by at least one of the T-cell assays. Following immunization with GS-4774, IFN-γ-producing T-cells specific for HBV antigens were detectable in 30 (51%) subjects. The ELISpot response was observed at all doses, with the highest frequency of responders occurring at the highest dose (10YU: 45%; 40YU: 35%; 80YU: 74%). Proliferative responses to HBV recombinant antigens were observed in 90% subjects; responses were mainly independent of GS-4774 dose and immunization regimen. GS-4774 was safe and well-tolerated in healthy subjects with injection-site reactions being the most frequently reported adverse events. With both weekly and monthly regimens, GS-4774 provided HBV-specific immune responses at all doses evaluated. Further evaluation of GS-4774 is ongoing in patients with chronic HBV infection. Clinical trial registry: Clinicaltrials.gov (NCT01779505) GS-4774 is a recombinant, heat-killed, yeast-based immunotherapy engineered to express hepatitis B virus (HBV)-specific antigens. GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection. The aim of this study was to assess the safety, tolerability and immunogenicity of GS-4774 in healthy subjects.BACKGROUNDGS-4774 is a recombinant, heat-killed, yeast-based immunotherapy engineered to express hepatitis B virus (HBV)-specific antigens. GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection. The aim of this study was to assess the safety, tolerability and immunogenicity of GS-4774 in healthy subjects.This was a randomized, open-label, dose-ascending study. Subjects were allocated to one of three dose groups (n=20 per group) to receive 10, 40 or 80 yeast units (YU; 1YU=10(7) yeast) of GS-4774 in two immunization regimens (five subcutaneous injections at weekly intervals with one monthly booster or three subcutaneous injections at monthly intervals). T-cell-mediated responses were determined by interferon (IFN)-γ enzyme-linked immunospot (ELISpot) assay and lymphocyte-proliferation assay (LPA).DESIGNThis was a randomized, open-label, dose-ascending study. Subjects were allocated to one of three dose groups (n=20 per group) to receive 10, 40 or 80 yeast units (YU; 1YU=10(7) yeast) of GS-4774 in two immunization regimens (five subcutaneous injections at weekly intervals with one monthly booster or three subcutaneous injections at monthly intervals). T-cell-mediated responses were determined by interferon (IFN)-γ enzyme-linked immunospot (ELISpot) assay and lymphocyte-proliferation assay (LPA).Adverse events were reported by 39 of 60 (65%) subjects; all were mild or moderate and none was serious. Adverse events occurred most frequently in the highest dose group, 80YU, and the number of individual events was higher after weekly immunization than monthly. The most common adverse events were injection-site reactions. Most (88%) subjects responded to GS-4774 by at least one of the T-cell assays. Following immunization with GS-4774, IFN-γ-producing T-cells specific for HBV antigens were detectable in 30 (51%) subjects. The ELISpot response was observed at all doses, with the highest frequency of responders occurring at the highest dose (10YU: 45%; 40YU: 35%; 80YU: 74%). Proliferative responses to HBV recombinant antigens were observed in 90% subjects; responses were mainly independent of GS-4774 dose and immunization regimen.RESULTSAdverse events were reported by 39 of 60 (65%) subjects; all were mild or moderate and none was serious. Adverse events occurred most frequently in the highest dose group, 80YU, and the number of individual events was higher after weekly immunization than monthly. The most common adverse events were injection-site reactions. Most (88%) subjects responded to GS-4774 by at least one of the T-cell assays. Following immunization with GS-4774, IFN-γ-producing T-cells specific for HBV antigens were detectable in 30 (51%) subjects. The ELISpot response was observed at all doses, with the highest frequency of responders occurring at the highest dose (10YU: 45%; 40YU: 35%; 80YU: 74%). Proliferative responses to HBV recombinant antigens were observed in 90% subjects; responses were mainly independent of GS-4774 dose and immunization regimen.GS-4774 was safe and well-tolerated in healthy subjects with injection-site reactions being the most frequently reported adverse events. With both weekly and monthly regimens, GS-4774 provided HBV-specific immune responses at all doses evaluated. Further evaluation of GS-4774 is ongoing in patients with chronic HBV infection.CONCLUSIONSGS-4774 was safe and well-tolerated in healthy subjects with injection-site reactions being the most frequently reported adverse events. With both weekly and monthly regimens, GS-4774 provided HBV-specific immune responses at all doses evaluated. Further evaluation of GS-4774 is ongoing in patients with chronic HBV infection.Clinicaltrials.gov (NCT01779505).CLINICAL TRIAL REGISTRYClinicaltrials.gov (NCT01779505). GS-4774 is a recombinant, heat-killed, yeast-based immunotherapy engineered to express hepatitis B virus (HBV)-specific antigens. GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection. The aim of this study was to assess the safety, tolerability and immunogenicity of GS-4774 in healthy subjects.This was a randomized, open-label, dose-ascending study. Subjects were allocated to one of three dose groups (n=20 per group) to receive 10, 40 or 80 yeast units (YU; 1YU=107 yeast) of GS-4774 in two immunization regimens (five subcutaneous injections at weekly intervals with one monthly booster or three subcutaneous injections at monthly intervals). T-cell-mediated responses were determined by interferon (IFN)-γ enzyme-linked immunospot (ELISpot) assay and lymphocyte-proliferation assay (LPA).Adverse events were reported by 39 of 60 (65%) subjects; all were mild or moderate and none was serious. Adverse events occurred most frequently in the highest dose group, 80YU, and the number of individual events was higher after weekly immunization than monthly. The most common adverse events were injection-site reactions. Most (88%) subjects responded to GS-4774 by at least one of the T-cell assays. Following immunization with GS-4774, IFN-γ-producing T-cells specific for HBV antigens were detectable in 30 (51%) subjects. The ELISpot response was observed at all doses, with the highest frequency of responders occurring at the highest dose (10YU: 45%; 40YU: 35%; 80YU: 74%). Proliferative responses to HBV recombinant antigens were observed in 90% subjects; responses were mainly independent of GS-4774 dose and immunization regimen.GS-4774 was safe and well-tolerated in healthy subjects with injection-site reactions being the most frequently reported adverse events. With both weekly and monthly regimens, GS-4774 provided HBV-specific immune responses at all doses evaluated. Further evaluation of GS-4774 is ongoing in patients with chronic HBV infection.Clinical trial registry: Clinicaltrials.gov (NCT01779505) GS-4774 is a recombinant, heat-killed, yeast-based immunotherapy engineered to express hepatitis B virus (HBV)-specific antigens. GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection. The aim of this study was to assess the safety, tolerability and immunogenicity of GS-4774 in healthy subjects. This was a randomized, open-label, dose-ascending study. Subjects were allocated to one of three dose groups (n=20 per group) to receive 10, 40 or 80 yeast units (YU; 1YU=10(7) yeast) of GS-4774 in two immunization regimens (five subcutaneous injections at weekly intervals with one monthly booster or three subcutaneous injections at monthly intervals). T-cell-mediated responses were determined by interferon (IFN)-γ enzyme-linked immunospot (ELISpot) assay and lymphocyte-proliferation assay (LPA). Adverse events were reported by 39 of 60 (65%) subjects; all were mild or moderate and none was serious. Adverse events occurred most frequently in the highest dose group, 80YU, and the number of individual events was higher after weekly immunization than monthly. The most common adverse events were injection-site reactions. Most (88%) subjects responded to GS-4774 by at least one of the T-cell assays. Following immunization with GS-4774, IFN-γ-producing T-cells specific for HBV antigens were detectable in 30 (51%) subjects. The ELISpot response was observed at all doses, with the highest frequency of responders occurring at the highest dose (10YU: 45%; 40YU: 35%; 80YU: 74%). Proliferative responses to HBV recombinant antigens were observed in 90% subjects; responses were mainly independent of GS-4774 dose and immunization regimen. GS-4774 was safe and well-tolerated in healthy subjects with injection-site reactions being the most frequently reported adverse events. With both weekly and monthly regimens, GS-4774 provided HBV-specific immune responses at all doses evaluated. Further evaluation of GS-4774 is ongoing in patients with chronic HBV infection. Clinicaltrials.gov (NCT01779505). Background GS-4774 is a recombinant, heat-killed, yeast-based immunotherapy engineered to express hepatitis B virus (HBV)-specific antigens. GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection. The aim of this study was to assess the safety, tolerability and immunogenicity of GS-4774 in healthy subjects. Design This was a randomized, open-label, dose-ascending study. Subjects were allocated to one of three dose groups (=20 per group) to receive 10, 40 or 80 yeast units (YU; 1YU=107 yeast) of GS-4774 in two immunization regimens (five subcutaneous injections at weekly intervals with one monthly booster or three subcutaneous injections at monthly intervals). T-cell-mediated responses were determined by interferon (IFN)- gamma enzyme-linked immunospot (ELISpot) assay and lymphocyte-proliferation assay (LPA). Results Adverse events were reported by 39 of 60 (65%) subjects; all were mild or moderate and none was serious. Adverse events occurred most frequently in the highest dose group, 80YU, and the number of individual events was higher after weekly immunization than monthly. The most common adverse events were injection-site reactions. Most (88%) subjects responded to GS-4774 by at least one of the T-cell assays. Following immunization with GS-4774, IFN- gamma -producing T-cells specific for HBV antigens were detectable in 30 (51%) subjects. The ELISpot response was observed at all doses, with the highest frequency of responders occurring at the highest dose (10YU: 45%; 40YU: 35%; 80YU: 74%). Proliferative responses to HBV recombinant antigens were observed in 90% subjects; responses were mainly independent of GS-4774 dose and immunization regimen. Conclusions GS-4774 was safe and well-tolerated in healthy subjects with injection-site reactions being the most frequently reported adverse events. With both weekly and monthly regimens, GS-4774 provided HBV-specific immune responses at all doses evaluated. Further evaluation of GS-4774 is ongoing in patients with chronic HBV infection. Clinical trial registry: Clinicaltrials.gov (NCT01779505) Background GS-4774 is a recombinant, heat-killed, yeast-based immunotherapy engineered to express hepatitis B virus (HBV)-specific antigens. GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection. The aim of this study was to assess the safety, tolerability and immunogenicity of GS-4774 in healthy subjects. Design This was a randomized, open-label, dose-ascending study. Subjects were allocated to one of three dose groups (n=20 per group) to receive 10, 40 or 80 yeast units (YU; 1YU=107yeast) of GS-4774 in two immunization regimens (five subcutaneous injections at weekly intervals with one monthly booster or three subcutaneous injections at monthly intervals). T-cell-mediated responses were determined by interferon (IFN)-γ enzyme-linked immunospot (ELISpot) assay and lymphocyte-proliferation assay (LPA). Results Adverse events were reported by 39 of 60 (65%) subjects; all were mild or moderate and none was serious. Adverse events occurred most frequently in the highest dose group, 80YU, and the number of individual events was higher after weekly immunization than monthly. The most common adverse events were injection-site reactions. Most (88%) subjects responded to GS-4774 by at least one of the T-cell assays. Following immunization with GS-4774, IFN-γ-producing T-cells specific for HBV antigens were detectable in 30 (51%) subjects. The ELISpot response was observed at all doses, with the highest frequency of responders occurring at the highest dose (10YU: 45%; 40YU: 35%; 80YU: 74%). Proliferative responses to HBV recombinant antigens were observed in 90% subjects; responses were mainly independent of GS-4774 dose and immunization regimen. Conclusions GS-4774 was safe and well-tolerated in healthy subjects with injection-site reactions being the most frequently reported adverse events. With both weekly and monthly regimens, GS-4774 provided HBV-specific immune responses at all doses evaluated. Further evaluation of GS-4774 is ongoing in patients with chronic HBV infection. Clinical trial registry: Clinicaltrials.gov (NCT01779505) |
| Author | Gaggar, Anuj Subramanian, G. Mani Coeshott, Claire Shen, Gong Apelian, David Armstrong, Brian R. Rodell, Timothy McHutchison, John G. |
| Author_xml | – sequence: 1 givenname: Anuj surname: Gaggar fullname: Gaggar, Anuj email: anuj.gaggar@gilead.com organization: Gilead Sciences, Inc., Foster City, CA, USA – sequence: 2 givenname: Claire surname: Coeshott fullname: Coeshott, Claire organization: GlobeImmune, Inc., Louisville, CO, USA – sequence: 3 givenname: David surname: Apelian fullname: Apelian, David organization: GlobeImmune, Inc., Louisville, CO, USA – sequence: 4 givenname: Timothy surname: Rodell fullname: Rodell, Timothy organization: GlobeImmune, Inc., Louisville, CO, USA – sequence: 5 givenname: Brian R. surname: Armstrong fullname: Armstrong, Brian R. organization: QST Consultations, Ltd., Allendale, MI, USA – sequence: 6 givenname: Gong surname: Shen fullname: Shen, Gong organization: Gilead Sciences, Inc., Foster City, CA, USA – sequence: 7 givenname: G. Mani surname: Subramanian fullname: Subramanian, G. Mani organization: Gilead Sciences, Inc., Foster City, CA, USA – sequence: 8 givenname: John G. surname: McHutchison fullname: McHutchison, John G. organization: Gilead Sciences, Inc., Foster City, CA, USA |
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| ContentType | Journal Article |
| Copyright | 2014 The Authors The Authors 2015 INIST-CNRS Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved. Copyright Elsevier Limited Sep 3, 2014 |
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| Keywords | Healthy subjects Vaccine HBV GS-4774 Hepatitis A virus Picornaviridae Orthohepadnavirus Hepatovirus Virus Immunogenicity Hepadnaviridae Immunotherapy Hepatitis B virus |
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| Snippet | •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... Highlights•GS-4774 is being developed as a therapeutic vaccine for chronic HBV infection. •GS-4774 consists of yeast cells that express well-conserved regions... GS-4774 is a recombinant, heat-killed, yeast-based immunotherapy engineered to express hepatitis B virus (HBV)-specific antigens. GS-4774 is being developed as... Background GS-4774 is a recombinant, heat-killed, yeast-based immunotherapy engineered to express hepatitis B virus (HBV)-specific antigens. GS-4774 is being... |
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| SubjectTerms | 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 |
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| Title | Safety, tolerability and immunogenicity of GS-4774, a hepatitis B virus-specific therapeutic vaccine, in healthy subjects: A randomized study |
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