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Characterisation of Human B Cell Maturation in Response to Vaccination (BVAC)

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ClinicalTrials.gov Identifier: NCT03535779
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Lucy Garvey, Imperial College Healthcare NHS Trust

Study Description
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Brief 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. Eights participants will be allocated to group 1 and eights participants to group 2 depending on their immunisation regime.

Condition or disease Intervention/treatment
Hepatitis B Biological: Hepatitis B Biological: Tetanus Toxoid

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Characterisation of Human B Cell Maturation in Response to Vaccination
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : March 13, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1
Healthy volunteers receiving Tetanus (Td/IVP) vaccine were enrolled onto the study for 1 month with no additional follow up visits.
 Biological: Tetanus Toxoid
The Tetanus vaccine, also known as tetanus toxoid (Td/IVP), is an inactive vaccine used to prevent tetanus in the population
Other Name: Td/IVP
Group 2
Healthy volunteers receiving the Hepatitis B (HBsAg) vaccine were enrolled onto the study for 2 months with no additional follow up visits.
 Biological: Hepatitis B
The Hepatitis B virus, is a double stranded DNA virus that prevents Hepatitis B in the population
Other Name: HBsAg


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy and male and female volunteers aged between 18 and 55 years old.
Criteria

Inclusion Criteria:

  1. Healthy male and female volunteers aged between 18 and 55 years scheduled to receive routine vaccination for HBsAg or booster immunisation with Td/IPV
  2. Previously naïve to HBsAg vaccination
  3. Available for the duration of the study
  4. Willing and able to give written informed consent

Exclusion Criteria:

  1. Is currently participating in another clinical trial with an investigational or non-investigational drug or device
  2. Unable to read and/or speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent
  3. Unlikely to comply with protocol
  4. Has a condition which in the opinion of the investigator is not suitable for participation in the trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535779


Locations
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United Kingdom
Dr Lucy Garvey
Paddington, United Kingdom
Sponsors and Collaborators
Imperial College London
More Information
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Additional Information:

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Responsible Party: Lucy Garvey, Consultant HIV/GU Medicine, Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT03535779    
Other Study ID Numbers: 16SM3542
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 1 year from when the study was officially closed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
 Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human