Hepatitis BPhase 4HVP01NCT03083158
Immunity to Hepatitis B Vaccine
A Phase 4 study testing Hepatitis B vaccine in people with Hepatitis B and Immunization; Infection, run by University of British Columbia at 1 site in Canada.
Trial summary
Infection and cancer is a major cause of death and morbidity, and may be preventable through vaccination. It is not fully understood at the molecular level why some people respond better than others to vaccines until now the technology to assess this has not been available. This has impaired vaccine development. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Immunization; Infection
- What is being tested?
- Hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2017to 1 Feb 2018
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult, corresponding to one of the study age groups.
- No history of hepatitis B disease.
- No prior receipt of any hepatitis B-containing vaccine.
- Undetectable level of anti-HBs and anti-HBc antibody and HBs antigen at study enrolment (indicating no evidence of prior hepatitis B vaccination or infection).
- Generally good health (stable chronic conditions acceptable), living independently or with minimal assistance (Clinical Frailty score 1-5) and able to attend clinic appointments.
- Willing and able to comply with the requirements of the protocol.
- Has given informed consent for participation in the study.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Individual who is on the delegation log for this study
- History of being a household contact of a known hepatitis B-infected individual.
- Planned administration of any vaccine not specified in the study protocol from 1 month pre- to the 1 month post-1st dose of vaccine.
- Planned receipt of any investigational drug for the duration of the study.
- Confirmed or suspected immunodeficiency.
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- A family history of congenital or hereditary immunodeficiency.
- Receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid) in the 3 months prior to dose 1 of vaccine. Nasal, topical or inhaled steroids are allowed.
- Currently taking any anti-platelet or anti-coagulant medications (does not include daily low-dose aspirin).
- Bleeding disorder or thrombocytopenia, that contraindicates IM injection, blood collection and/or lymph node fine needle aspiration.
- Administration of immunoglobulins within the prior 12 months and/or any other blood products within the prior 3 months or planned during the study period.
- Current pregnancy or planning to become pregnant in the 6 months post-dose 1 vaccination.
- History of allergy to any component of the vaccine.
- Unstable medical condition, as indicated by a requirement for hospitalization or a substantial medication change to stabilize said condition within previous 3 months.
- History of any neurologic disorders or seizures, including a history of Guillain-Barre syndrome.
- Clinical Frailty score of 6-7 (moderately frail or severely frail).
- Scheduled elective surgery or other procedures requiring general anaesthesia from 1 month pre- to the 1 month post-1st dose of vaccine.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Temporary exclusion if acute symptomatic illness in the 7 days prior to planned first vaccine dose - vaccination will be delayed, but participant can remain in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Age-dependent Mechanism of Vaccine-induced Immunity to a Single Dose of Hepatitis B Vaccine Using a Systems Biology Approach - a Demonstration Project
Infection and cancer is a major cause of death and morbidity, and may be preventable through vaccination. It is not fully understood at the molecular level why some people respond better than others to vaccines until now the technology to assess this has not been available. This has impaired vaccine development. The overall goal of the Human Vaccines Project is to understand the 'rules' of how vaccines work. In this demonstration project the investigators will vaccinate healthy adults with hepatitis B vaccine to start to understand better how it works, ultimately helping with rational vaccine design in the future.
- Conditions
- Hepatitis B, Immunization; Infection
- Being tested
- Hepatitis B vaccine
- Medical subject headings
- Hepatitis B, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B vaccineDrug
Also called ENGERIX®-B
1.0 ml (20 micrograms) suspension of hepatitis B surface antigen for intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Older adults, aged 61-80 years Receives: Drug: Hepatitis B vaccine |
| Group 2 | Other | Younger adults, aged 40-60 years Receives: Drug: Hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response to the first dose of hepatitis B vaccine
Anti-HBs antibody level
Measured: 28 days post-vaccination following the first dose of vaccine
Secondary outcomes (7)
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to cellular immune response
Immunophenotyping by flow cytometric analysis of immune cell populations, including antigen-specific T-cell and B-cell responses, and response of immune cells to various stimuli in vitro
Measured: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to transcriptomic response
Gene expression by RNA sequencing of whole blood and single immune cells
Measured: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to proteomic response
Proteomic analysis of plasma and white blood cells
Measured: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to metabalomic response
Metabolomic analysis of plasma
Measured: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to epigenetic response
Epigenetic changes in genome
Measured: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to lymph node response
Immune responses in local lymph node, and comparison with peripheral blood responses
Measured: Pre-vaccine and 14 days following first dose only
Identify the DNA sequence of B- and T- cell receptors following vaccination
DNA sequencing of T- and B- cells
Measured: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start6 Mar 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, J. Craig Venter Institute, The Scripps Research Institute, University of California, San Diego, Institut Pasteur, Human Vaccines Project
- Responsible party
- Principal investigator, Manish Sadarangani, University of British Columbia
- Investigators
- Manish Sadarangani, Principal investigator, University of British ColumbiaTobi Kollmann, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083158
- Sponsor's protocol ID
- H17-00175
- Acronym
- HVP01
- Status last verified
- Nov 2020
- First submitted
- 9 Mar 2017
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Age-dependent Mechanism of Vaccine-induced Immunity to a Single Dose of Hepatitis B Vaccine Using a Systems Biology Approach - a Demonstration Project
- ClinicalTrials.gov ID
- NCT03083158
- Acronym / sponsor ID
- HVP01 / H17-00175
- Conditions
- Hepatitis B, Immunization; Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vanderbilt University, J. Craig Venter Institute, The Scripps Research Institute, University of California, San Diego, Institut Pasteur, Human Vaccines Project
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 17 Mar 2017 (actual)
- 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.
Infection and cancer is a major cause of death and morbidity, and may be preventable through vaccination. It is not fully understood at the molecular level why some people respond better than others to vaccines until now the technology to assess this has not been available. This has impaired vaccine development. The overall goal of the Human Vaccines Project is to understand the 'rules' of how vaccines work. In this demonstration project the investigators will vaccinate healthy adults with hepatitis B vaccine to start to understand better how it works, ultimately helping with rational vaccine design in the future.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: Hepatitis B vaccineOlder adults, aged 61-80 years |
| Group 2 | Other | Drug: Hepatitis B vaccineYounger adults, aged 40-60 years |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy adult, corresponding to one of the study age groups.
- No history of hepatitis B disease.
- No prior receipt of any hepatitis B-containing vaccine.
- Undetectable level of anti-HBs and anti-HBc antibody and HBs antigen at study enrolment (indicating no evidence of prior hepatitis B vaccination or infection).
- Generally good health (stable chronic conditions acceptable), living independently or with minimal assistance (Clinical Frailty score 1-5) and able to attend clinic appointments.
Key exclusion criteria (19 listed)
- Individual who is on the delegation log for this study
- History of being a household contact of a known hepatitis B-infected individual.
- Planned administration of any vaccine not specified in the study protocol from 1 month pre- to the 1 month post-1st dose of vaccine.
- Planned receipt of any investigational drug for the duration of the study.
- Confirmed or suspected immunodeficiency.
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 vaccineAlso: ENGERIX®-B1.0 ml (20 micrograms) suspension of hepatitis B surface antigen for intramuscular injection | Drug | Group 1, Group 2 |
Primary outcome
Antibody response to the first dose of hepatitis B vaccine
Time frame: 28 days post-vaccination following the first dose of vaccine
Anti-HBs antibody level
7 secondary outcomes
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to cellular immune response
Time frame: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to transcriptomic response
Time frame: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to proteomic response
Time frame: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to metabalomic response
Time frame: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to epigenetic response
Time frame: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to lymph node response
Time frame: Pre-vaccine and 14 days following first dose only
Identify the DNA sequence of B- and T- cell receptors following vaccination
Time frame: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination
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 25 Nov 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatitis B
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A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
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Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
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Recruiting
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RecruitingObservational study
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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.
Manish Sadarangani principal investigator
University of British Columbia
Tobi Kollmann principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hepatitis B vaccine in people with Hepatitis B and Immunization; Infection, run by University of British Columbia at 1 site in Canada.
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 7 inclusion and 19 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 25 Nov 2020. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Antibody response to the first dose of hepatitis B vaccine (time frame: 28 days post-vaccination following the first dose of vaccine). 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 25 Nov 2020.