Healthy VolunteersPhase 1NCT01779505
A Phase 1a Trial Assessing the Safety, Tolerability, and Immunogenicity of GS-4774 (GI-13020) at Various Dose Levels and Regimens in Healthy Adults
A Phase 1 study testing GS-4774 in people with Healthy Volunteers, run by Gilead Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GS-4774
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
- History of autoimmune disease
- History of organ transplantation
- Concurrent and chronic therapy with immunosuppressive drugs including systemic corticosteroids
- Receipt of investigational drugs or vaccines within 30 days or 5 half lives, whichever is longer, prior to first injection with the study drug
- Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
- Receipt of allergy shots within the preceding 7 days or expected to receive allergy shots during the study and 7 days following completion of study
- Receipt of biologics
- Negative histamine response on scratch test at screening
- High risk for noncompliance with the protocol
- Alcohol and/or IV drug abuse within the past year
- Positive urine drug test at screen visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Multi-Arm, Dose Escalation, Phase 1a Trial Assessing the Safety, Tolerability, and Immunogenicity of GI-13020; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Hepatitis B Virus X, Surface and Core Antigens, at Various Dose Levels and Regimens in Healthy Adults.
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.
Read the detailed description
HBV specific T cell responses have been shown to have a positive association with infection status in patients with chronic HBV, with the weakest T cell responses in patients with untreated chronic active infection and the strongest T cell responses in patients who have achieved seroconversion or cure (4). We have generated a Tarmogen expressing well conserved regions of the HBV X, S, and core antigens (GS-4774). GS-4774 is immunogenic in murine models and has also been used to stimulate human immune cell samples ex vivo to elicit HBV specific T cell responses which could predict the immune responses in patients dosed with GS-4774. GS-4774 will be evaluated in this healthy volunteer study to assess its safety, tolerability, and ability to elicit HBV specific T cell responses. In the future GS-4774 could be used in combination with HBV antivirals, such as tenofovir disoproxil fumarate, in an attempt to improve HBsAg seroconversion (cure) rates in patients with chronic HBV infection.
- Conditions
- Healthy Volunteers
- Being tested
- GS-4774
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-4774Biological
Also called GI-13020
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.
| Study group | Role | What they receive |
|---|---|---|
| GS-4774 at 10 yeast units (YU) | Experimental | 10 YU of GS-4774 given either weekly or monthly Receives: Biological: GS-4774 |
| GS-4774 at 40 YU | Experimental | 40 YU of GS-4774 given either weekly or monthly Receives: Biological: GS-4774 |
| GS-4774 at 80YU | Experimental | 80 YU of GS-4774 given either weekly or monthly Receives: Biological: GS-4774 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Immunogenicity of various doses and dosing regimens of GS-4774
Frequency and magnitude of antigen specific immune responses by enzyme-linked immunosorbent spot (ELISpot) assay for cytokine production, to include interferon gamma (IFNγ) Frequency and magnitude of antigen specific immune responses by lymphocyte proliferation assay (LPA) Frequency and magnitude of anti-Saccharomyces cerevisiae antibody (ASCA) responses Pentamer staining for HBV specific T cells Frequency of regulatory T cells (Treg) responses
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779505
- Sponsor's protocol ID
- GI-13020-01
- Status last verified
- Jan 2014
- First submitted
- 24 Jan 2013
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25045824
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multi-Arm, Dose Escalation, Phase 1a Trial Assessing the Safety, Tolerability, and Immunogenicity of GI-13020; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Hepatitis B Virus X, Surface and Core Antigens, at Various Dose Levels and Regimens in Healthy Adults.
- ClinicalTrials.gov ID
- NCT01779505
- Acronym / sponsor ID
- GI-13020-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HBV specific T cell responses have been shown to have a positive association with infection status in patients with chronic HBV, with the weakest T cell responses in patients with untreated chronic active infection and the strongest T cell responses in patients who have achieved seroconversion or cure (4). We have generated a Tarmogen expressing well conserved regions of the HBV X, S, and core antigens (GS-4774). GS-4774 is immunogenic in murine models and has also been used to stimulate human immune cell samples ex vivo to elicit HBV specific T cell responses which could predict the immune responses in patients dosed with GS-4774. GS-4774 will be evaluated in this healthy volunteer study to assess its safety, tolerability, and ability to elicit HBV specific T cell responses. In the future GS-4774 could be used in combination with HBV antivirals, such as tenofovir disoproxil fumarate, in an attempt to improve HBsAg seroconversion (cure) rates in patients with chronic HBV infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GS-4774 at 10 yeast units (YU) | Experimental | Biological: GS-477410 YU of GS-4774 given either weekly or monthly |
| GS-4774 at 40 YU | Experimental | Biological: GS-477440 YU of GS-4774 given either weekly or monthly |
| GS-4774 at 80YU | Experimental | Biological: GS-477480 YU of GS-4774 given either weekly or monthly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-4774Also: GI-13020GS-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. | Biological | GS-4774 at 10 yeast units (YU), GS-4774 at 40 YU, GS-4774 at 80YU |
Primary outcome
Safety of GS-4774 at various doses
Time frame: 6 months
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
1 secondary outcome
Immunogenicity of various doses and dosing regimens of GS-4774
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
- Derived from this study: PubMed 25045824Gaggar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-4774 in people with Healthy Volunteers, run by Gilead Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of GS-4774 at various doses (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2014.