NCT03083158

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

March 9, 2017

Last Update Submit

November 23, 2020

Conditions

Hepatitis BImmunization; Infection

Outcome Measures

Primary Outcomes (1)

  • Antibody response to the first dose of hepatitis B vaccine

    Anti-HBs antibody level

    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

    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

    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

    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

    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

    Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination

  • +2 more secondary outcomes

Other Outcomes (5)

  • To correlate the 'omics immune responses measured after the first dose with antibody level after the 1st and 3rd doses

    Days 1, 3, 7 and 14 post-first dose of vaccine and 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

    Day 14 pre-first dose of vaccine and day 28 post-first dose of vaccine

  • 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

    Day 14 post-first dose of vaccine

  • +2 more other outcomes

Study Arms (2)

Group 1

OTHER

Older adults, aged 61-80 years

Drug: Hepatitis B vaccine

Group 2

OTHER

Younger adults, aged 40-60 years

Drug: Hepatitis B vaccine

Interventions

Hepatitis B vaccineDRUG

1.0 ml (20 micrograms) suspension of hepatitis B surface antigen for intramuscular injection

Also known as: ENGERIX®-B
Group 1Group 2

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaccine Evaluation Center

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Related Links

MeSH Terms

Conditions

Hepatitis BInfections

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Manish Sadarangani

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Tobi Kollmann

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 17, 2017

Study Start

March 6, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

November 25, 2020

Record last verified: 2020-11

Locations

CA(1)