NCT01779505

Brief Summary

This trial will be test the safety, tolerability, and immunogenicity of GS-4774 (GI-13020) in various doses and dosing regimens in healthy adults at one center in the US. Subjects will be enrolled into 3 arms using a dose escalation scheme and randomized into one of two dosing regimen cohorts. There will be 10 subjects per arm/cohort (total of 60 subjects to achieve 48 evaluable subjects enrolled), with study completion in 9-12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2013

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 8, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

January 24, 2013

Last Update Submit

January 6, 2014

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Safety of GS-4774 at various doses

    Frequency of serious adverse events Frequency and severity of common non-serious adverse events Frequency of discontinuations of therapy due to adverse events Common laboratory assessments (chemistry, hematology, urinalysis) Dose Limiting Toxicities

    6 months

Secondary Outcomes (1)

  • Immunogenicity of various doses and dosing regimens of GS-4774

    6 months

Study Arms (3)

GS-4774 at 10 yeast units (YU)

EXPERIMENTAL

10 YU of GS-4774 given either weekly or monthly

Biological: GS-4774

GS-4774 at 40 YU

EXPERIMENTAL

40 YU of GS-4774 given either weekly or monthly

Biological: GS-4774

GS-4774 at 80YU

EXPERIMENTAL

80 YU of GS-4774 given either weekly or monthly

Biological: GS-4774

Interventions

GS-4774BIOLOGICAL

GS-4774 is a recombinant yeast-based biological product engineered to express HBV antigens. The product is a heat-killed yeast (S. cerevisiae) containing a chimera of HBV X, Score, and Core antigens.

Also known as: GI-13020
GS-4774 at 10 yeast units (YU)GS-4774 at 40 YUGS-4774 at 80YU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed, written, informed consent from the subject before any study-specific procedures are performed
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study
  • If female, negative pregnancy test and for women of childbearing potential willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication
  • Male or female aged ≥ 18 years at the time of first dose
  • Negative scratch test (immediate hypersensitivity, immunoglobulin E (IgE) mediated) to S. cerevisiae

You may not qualify if:

  • Hospitalization in the last 6 months
  • No medicine adjustments in the last 6 months
  • History of anaphylaxis from any cause
  • History of hepatitis B virus (HBV) infection as evidenced by detection of HBV Surface and Core antigens
  • History of vaccination with HBV prophylactic vaccine or positive for antibody to HBV Surface and Core antigens
  • Known exposure to HBV within the past 6 weeks
  • Increased alpha fetoprotein (AFP) at screening
  • History of hepatitis C virus (HCV) infection or positive HCV antibody, Herpes zoster, shingles or any other chronic viral infection
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
  • Known history of HIV infection or positive HIV antibody test at screening
  • History of demyelinating disease such as Guillain-Barre Syndrome
  • History of Bell's Palsy
  • Immunosuppression as a result of underlying illness or treatment
  • History of cancer within the last 5 years with the exception of localized basal or squamous cell carcinoma or Stage 1A cervical cancer
  • History of Crohn's disease or ulcerative colitis
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Phoenix, Arizona, 85283, United States

Location

Related Publications (1)

  • Gaggar A, Coeshott C, Apelian D, Rodell T, Armstrong BR, Shen G, Subramanian GM, McHutchison JG. Safety, tolerability and immunogenicity of GS-4774, a hepatitis B virus-specific therapeutic vaccine, in healthy subjects: a randomized study. Vaccine. 2014 Sep 3;32(39):4925-31. doi: 10.1016/j.vaccine.2014.07.027. Epub 2014 Jul 18.

    PMID: 25045824DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 30, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 8, 2014

Record last verified: 2014-01

Locations

US(1)