Hepatitis BNCT02055365
Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
A study testing Hepatitis B Vaccine (Recombinant) in people with Hepatitis B, run by Rockefeller University at 1 site in United States.
Trial summary
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity.This study aims to define cellular functions and genes important for the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Hepatitis B Vaccine (Recombinant)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2014to 6 Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer without significant medical problems
- Willing to receive three doses of an FDA-approved Hepatitis B vaccine
Who cannot join
- Male or female < 18 and > 60 years of age
- Received any vaccine within a month prior to study vaccine
- History of Hepatitis B infection
- History of previous Hepatitis B vaccination(s)
- History of Hepatitis C virus (HCV) infection or positive HCV antibody test
- Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
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- Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
- human immunodeficiency virus (HIV) positive
- In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
- Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease
- Is pregnant or lactating
- Currently taking systemic steroids or other immunomodulatory medications including anticancer medications and antiviral medications
- Any clinically significant acute or chronic medical condition requiring care by a primary care provider (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation
- Unable to continue participation for 30 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Official title: Effects of Persistent Innate Immune Activation on Vaccine Efficacy Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity.This study aims to define cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
Read the detailed description
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity. Knowledge of those genes and cellular functions activated by effective vaccination can improve our understanding of how the immune system works and define the features necessary for a successful vaccine response. This study aims to define cellular functions important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators will identify those genes that are activated or suppressed in immune cells at various times after each dose of the HBV vaccine. The investigators will explore these vaccine-induced "gene signatures" to characterize the cellular functions associated with an effective immune response to HBV vaccination. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
- Conditions
- Hepatitis B
- Being tested
- Hepatitis B Vaccine (Recombinant)
- Keywords
- Hepatitis B vaccine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B Vaccine (Recombinant)Biological
Also called Recombivax HB - Merck & Co., Inc.
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B vaccination | Experimental | All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). Receives: Biological: Hepatitis B Vaccine (Recombinant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).
Number of differentially expressed genes at time point versus prevaccination baseline (p<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
Measured: Day 1, Day 3, Week 1, and Week 2
Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).
Number of significantly differentially expressed genes at time point versus prevaccination baseline (FDR<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
Measured: Day 1, Day 3, Week 1, and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study start18 Feb 2014
- Primary completion6 Jan 2015
- Study completion6 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Rosenberg, Rockefeller University
- Investigators
- Brad Rosenberg, MD, PhD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055365
- Sponsor's protocol ID
- BRO-0828
- Status last verified
- Apr 2018
- First submitted
- 3 Feb 2014
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Persistent Innate Immune Activation on Vaccine Efficacy Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02055365
- Acronym / sponsor ID
- BRO-0828
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- 18 Feb 2014 (actual)
- Primary completion
- 6 Jan 2015 (actual)
- Study completion
- 6 Jan 2015 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Posted 5 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity.This study aims to define cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
Detailed description
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity. Knowledge of those genes and cellular functions activated by effective vaccination can improve our understanding of how the immune system works and define the features necessary for a successful vaccine response. This study aims to define cellular functions important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators will identify those genes that are activated or suppressed in immune cells at various times after each dose of the HBV vaccine. The investigators will explore these vaccine-induced "gene signatures" to characterize the cellular functions associated with an effective immune response to HBV vaccination. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B vaccination | Experimental | Biological: Hepatitis B Vaccine (Recombinant)All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteer without significant medical problems
- Willing to receive three doses of an FDA-approved Hepatitis B vaccine
Key exclusion criteria (14 listed)
- Male or female < 18 and > 60 years of age
- Received any vaccine within a month prior to study vaccine
- History of Hepatitis B infection
- History of previous Hepatitis B vaccination(s)
- History of Hepatitis C virus (HCV) infection or positive HCV antibody test
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 |
|---|---|---|
| Hepatitis B Vaccine (Recombinant)Also: Recombivax HB - Merck & Co., Inc.All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). | Biological | Hepatitis B vaccination |
Primary outcome
Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).
Time frame: Day 1, Day 3, Week 1, and Week 2
Number of differentially expressed genes at time point versus prevaccination baseline (p<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).
Time frame: Day 1, Day 3, Week 1, and Week 2
Number of significantly differentially expressed genes at time point versus prevaccination baseline (FDR<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatitis B
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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.
Brad Rosenberg, MD, PhD principal investigator
The Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatitis B Vaccine (Recombinant) in people with Hepatitis B, run by Rockefeller University 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 2 inclusion and 14 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 7 May 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction). (time frame: Day 1, Day 3, Week 1, and Week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2018.