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Trial record 2 of 304 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Immunity to Hepatitis B Vaccine (HVP01)

This study is currently recruiting participants.
Verified March 2017 by Manish Sadarangani, University of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT03083158
First Posted: March 17, 2017
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Vanderbilt University
J. Craig Venter Institute
The Scripps Research Institute
University of California, San Diego
Institut Pasteur
Human Vaccines Project
Information provided by (Responsible Party):
Manish Sadarangani, University of British Columbia
  Purpose
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.

Condition Intervention Phase
Hepatitis B Immunization; Infection Drug: Hepatitis B vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Manish Sadarangani, University of British Columbia:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]
    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

  • 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 ]
    Gene expression by RNA sequencing of whole blood and single immune cells

  • 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 ]
    Proteomic analysis of plasma and white blood cells

  • 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 ]
    Metabolomic analysis of plasma

  • 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 ]
    Epigenetic changes in genome

  • 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 ]
    Immune responses in local lymph node, and comparison with peripheral blood responses

  • 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 ]
    DNA sequencing of T- and B- cells


Other Outcome Measures:
  • To correlate the 'omics immune responses measured after the first dose with antibody level after the 1st and 3rd doses [ Time Frame: Days 1, 3, 7 and 14 post-first dose of vaccine and 28 days after the 1st and 3rd doses of vaccine ]
    Correlation of immune endpoints (all secondary endpoints - outcomes 2 to 8) at days 1, 3, 7 and 14 post-first dose of vaccine and anti-HBs antibody level 28 days after the 1st and 3rd doses of vaccine

  • The influence of the gut, skin, buccal and nasal microbiota on responses to a single dose of hepatitis B vaccine - microbiome measured by 16S rDNA sequencing and vaccine response measured by anti-HBS antibody [ Time Frame: Day 14 pre-first dose of vaccine and day 28 post-first dose of vaccine ]
    Correlation of gut, skin, buccal and nasal microbiota (obtained pre-vaccination) with HBV vaccine response.

  • The influence of a single dose of hepatitis B vaccine on the gut, skin, buccal and nasal microbiota - microbiome measured by 16S rDNA sequencing and vaccine response measured by anti-HBS antibody [ Time Frame: Day 14 post-first dose of vaccine ]
    Analysis of changes in gut, skin, buccal and nasal microbiota obtained following vaccination

  • The quality of the antibody response following hepatitis B vaccination, measured by antibody subclass and avidity [ Time Frame: Pre-vaccine and 1 month after the 1st dose, 5 months after the 2nd dose (6 months after 1st dose) and 1 month after the 3rd dose of vaccine ]
    Analysis of antibody subclass and avidity pre-vaccine and 1 month after the 1st dose, 5 months after the 2nd dose (6 months after 1st dose) and 1 month after the 3rd dose of vaccine

  • The genetic changes in B- and T-cells following doses of hepatitis B vaccine, measured by T cell and B cell receptpr sequencing [ Time Frame: 28 days after the 1st dose, 7 days and 5 months after the 2nd dose (6 months after the 1st dose) and 7 days and 28 days after the 3rd dose of hepatitis B vaccine ]
    DNA sequencing of B- and T- cells 28 days after the 1st dose, 7 days and 5 months after the 2nd dose (6 months after the 1st dose) and 7 days and 28 days after the 3rd dose of hepatitis B vaccine


Estimated Enrollment: 20
Actual Study Start Date: March 6, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
Older adults, aged 61-80 years
Drug: Hepatitis B vaccine
1.0 ml (20 micrograms) suspension of hepatitis B surface antigen for intramuscular injection
Other Name: ENGERIX®-B
Group 2
Younger adults, aged 40-60 years
Drug: Hepatitis B vaccine
1.0 ml (20 micrograms) suspension of hepatitis B surface antigen for intramuscular injection
Other Name: ENGERIX®-B

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.
  • 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.
  Contacts and Locations
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): NCT03083158


Contacts
Contact: Cecilia Jankowski +16048752422 cjankowski@bcchr.ubc.ca

Locations
Canada, British Columbia
Vaccine Evaluation Center Recruiting
Vancouver, British Columbia, Canada, V5Z 4H4
Contact: Cecilia Jankowski    +16048752422    cjankowski@bcchr.ubc.ca   
Sponsors and Collaborators
University of British Columbia
Vanderbilt University
J. Craig Venter Institute
The Scripps Research Institute
University of California, San Diego
Institut Pasteur
Human Vaccines Project
Investigators
Principal Investigator: Manish Sadarangani University of British Columbia
Principal Investigator: Tobi Kollmann University of British Columbia
  More Information

Additional Information:
Responsible Party: Manish Sadarangani, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03083158     History of Changes
Other Study ID Numbers: H17-00175
First Submitted: March 9, 2017
First Posted: March 17, 2017
Last Update Posted: March 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs