Hepatitis BBVACNCT03535779
Characterisation of Human B Cell Maturation in Response to Vaccination
An observational study of Hepatitis B, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study is an exploratory single site sample collection study at St Mary's hospital campus, Imperial College London. Sixteen participants scheduled to receive routine immunizations for Td/IPV (group 1) and HBsAg (group 2) will be recruited overall. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Hepatitis B and Tetanus Toxoid
- Type of treatment
- Vaccines
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2017to 13 Mar 2018
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy and male and female volunteers aged between 18 and 55 years old.
Who may be able to join
- Healthy male and female volunteers aged between 18 and 55 years scheduled to receive routine vaccination for HBsAg or booster immunisation with Td/IPV
- Previously naïve to HBsAg vaccination
- Available for the duration of the study
- Willing and able to give written informed consent
Who cannot join
- Is currently participating in another clinical trial with an investigational or non-investigational drug or device
- Unable to read and/or speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent
- Unlikely to comply with protocol
- Has a condition which in the opinion of the investigator is not suitable for participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
This study is an exploratory single site sample collection study at St Mary's hospital campus, Imperial College London. Sixteen participants scheduled to receive routine immunizations for Td/IPV (group 1) and HBsAg (group 2) will be recruited overall. Eights participants will be allocated to group 1 and eights participants to group 2 depending on their immunisation regime.
Read the detailed description
The aim of the study is to characterise the maturation of human B cell response to immunization with vaccines (HBsAg and Td/IPV) known to induce long-term memory responses.
The primary objective is to characterize the number and phenotype of memory B cells induced by routine vaccination. These responses will be used as a comparison to those currently induced in HIV-1 vaccination trials.
The development of an effective HIV-1 vaccine is highly dependent on our understanding of the immune response to HIV-1 infection/vaccination. It is generally accepted that the generation of long-lived neutralising memory B cell antibody responses will be critical for an effective vaccine against HIV-1. Successful vaccines are capable of inducing long-lived B cell memory that can maintain antibodies for decades, typical examples being those induced by Hepatitis B (HBsAg) and tetanus vaccination which generates antibodies with a half-life of greater than 5 years. In contrast, current HIV-1 vaccination typically induces a short-lived B cell response with antibodies waning within a half-life of 6 months. Recent observations have shown that vaccination does not produce a homogenous population of memory B cell but rather a constellation of subsets depending on the type of vaccination.
Investigators are only beginning to understand the varying and important roles of some of these elusive subsets. Therefore understanding potential differential responses of these memory B cell subsets to successful licensed vaccines may prove critical in the creation of novel, effective vaccines to HIV-1.
The field has been energised in recent years by the identification of different memory B cell subsets. Four of these subsets can be characterised through differential expression of surface markers CD27, IgD and IgM, typically: CD27+IgD+IgM+ B cells, CD27+IgD-IgM+ B cells, CD27+IgD+IgM- B cells and CD27+IgD-IgM- IgG+/IgA+/IgE+ B cells (Mroczek ES et al, Front Immunol. 2014;5:96). Understanding how HBsAg and tetanus (as part of the Td/IPV vaccine) modulates antigen specific responses across these four memory B cell subsets will help define how Investigators understand the establishment of long-term immunological memory and may help us understand how Investigators can induce such memory responses with new HIV vaccine candidates. Data from these studies will be used to compare responses elicited by HIV vaccines in current phase I studies and determine potential defects in the maturation of vaccine induced memory.
Investigators therefore wish to obtain blood draws from individuals undergoing routine HBsAg and Td/IPV vaccination. This will allow us to isolate memory B cells circulating in the peripheral blood and characterise the different memory B cell subsets induced by effective licensed vaccines and compare responses to those induced by current HIV-1 vaccination trials, for which Investigators already have samples banked.
- Conditions
- Hepatitis B
- Being tested
- Hepatitis B, Tetanus Toxoid
- 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 BBiological
Also called HBsAg
The Hepatitis B virus, is a double stranded DNA virus that prevents Hepatitis B in the population
Tetanus ToxoidBiological
Also called Td/IVP
The Tetanus vaccine, also known as tetanus toxoid (Td/IVP), is an inactive vaccine used to prevent tetanus in the population
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Healthy volunteers receiving Tetanus (Td/IVP) vaccine were enrolled onto the study for 1 month with no additional follow up visits. Receives: Biological: Tetanus Toxoid | |
| Group 2 | Healthy volunteers receiving the Hepatitis B (HBsAg) vaccine were enrolled onto the study for 2 months with no additional follow up visits. Receives: Biological: Hepatitis B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory B Cells
The primary endpoint will measure the proportion responding B cells in one of four memory B cell subsets (defined by differential expression of CD27, IgD and IgM markers) raised in response to HBsAg and Td/IPV vaccination.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start6 Mar 2017
- Primary completion15 Jun 2017
- Study completion13 Mar 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 Imperial College LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy Garvey, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535779
- Sponsor's protocol ID
- 16SM3542
- Acronym
- BVAC
- Status last verified
- Jun 2018
- First submitted
- 14 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Human B Cell Maturation in Response to Vaccination
- ClinicalTrials.gov ID
- NCT03535779
- Acronym / sponsor ID
- BVAC / 16SM3542
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 24 May 2018 (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.
This study is an exploratory single site sample collection study at St Mary's hospital campus, Imperial College London. Sixteen participants scheduled to receive routine immunizations for Td/IPV (group 1) and HBsAg (group 2) will be recruited overall. Eights participants will be allocated to group 1 and eights participants to group 2 depending on their immunisation regime.
Detailed description
The aim of the study is to characterise the maturation of human B cell response to immunization with vaccines (HBsAg and Td/IPV) known to induce long-term memory responses.
The primary objective is to characterize the number and phenotype of memory B cells induced by routine vaccination. These responses will be used as a comparison to those currently induced in HIV-1 vaccination trials.
The development of an effective HIV-1 vaccine is highly dependent on our understanding of the immune response to HIV-1 infection/vaccination. It is generally accepted that the generation of long-lived neutralising memory B cell antibody responses will be critical for an effective vaccine against HIV-1. Successful vaccines are capable of inducing long-lived B cell memory that can maintain antibodies for decades, typical examples being those induced by Hepatitis B (HBsAg) and tetanus vaccination which generates antibodies with a half-life of greater than 5 years. In contrast, current HIV-1 vaccination typically induces a short-lived B cell response with antibodies waning within a half-life of 6 months. Recent observations have shown that vaccination does not produce a homogenous population of memory B cell but rather a constellation of subsets depending on the type of vaccination.
Investigators are only beginning to understand the varying and important roles of some of these elusive subsets. Therefore understanding potential differential responses of these memory B cell subsets to successful licensed vaccines may prove critical in the creation of novel, effective vaccines to HIV-1.
The field has been energised in recent years by the identification of different memory B cell subsets. Four of these subsets can be characterised through differential expression of surface markers CD27, IgD and IgM, typically: CD27+IgD+IgM+ B cells, CD27+IgD-IgM+ B cells, CD27+IgD+IgM- B cells and CD27+IgD-IgM- IgG+/IgA+/IgE+ B cells (Mroczek ES et al, Front Immunol. 2014;5:96). Understanding how HBsAg and tetanus (as part of the Td/IPV vaccine) modulates antigen specific responses across these four memory B cell subsets will help define how Investigators understand the establishment of long-term immunological memory and may help us understand how Investigators can induce such memory responses with new HIV vaccine candidates. Data from these studies will be used to compare responses elicited by HIV vaccines in current phase I studies and determine potential defects in the maturation of vaccine induced memory.
Investigators therefore wish to obtain blood draws from individuals undergoing routine HBsAg and Td/IPV vaccination. This will allow us to isolate memory B cells circulating in the peripheral blood and characterise the different memory B cell subsets induced by effective licensed vaccines and compare responses to those induced by current HIV-1 vaccination trials, for which Investigators already have samples banked.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: Tetanus ToxoidHealthy volunteers receiving Tetanus (Td/IVP) vaccine were enrolled onto the study for 1 month with no additional follow up visits. |
| Group 2 | – | Biological: Hepatitis BHealthy volunteers receiving the Hepatitis B (HBsAg) vaccine were enrolled onto the study for 2 months with no additional follow up visits. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy and male and female volunteers aged between 18 and 55 years old.
Key inclusion criteria (4 listed)
- Healthy male and female volunteers aged between 18 and 55 years scheduled to receive routine vaccination for HBsAg or booster immunisation with Td/IPV
- Previously naïve to HBsAg vaccination
- Available for the duration of the study
- Willing and able to give written informed consent
Key exclusion criteria (4 listed)
- Is currently participating in another clinical trial with an investigational or non-investigational drug or device
- Unable to read and/or speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent
- Unlikely to comply with protocol
- Has a condition which in the opinion of the investigator is not suitable for participation in the trial
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 BAlso: HBsAgThe Hepatitis B virus, is a double stranded DNA virus that prevents Hepatitis B in the population | Biological | Group 2 |
| Tetanus ToxoidAlso: Td/IVPThe Tetanus vaccine, also known as tetanus toxoid (Td/IVP), is an inactive vaccine used to prevent tetanus in the population | Biological | Group 1 |
Primary outcome
Memory B Cells
Time frame: 12 months
The primary endpoint will measure the proportion responding B cells in one of four memory B cell subsets (defined by differential expression of CD27, IgD and IgM markers) raised in response to HBsAg and Td/IPV 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 20 Jun 2018.
- Individual participant dataSharing planned: Yes
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Chronic Hepatitis B
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?
An observational study of Hepatitis B, run by Imperial College London at 1 site in United Kingdom.
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 4 inclusion and 4 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 20 Jun 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 Kingdom. 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?
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?
Memory B Cells (time frame: 12 months). 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 20 Jun 2018.