Immunity to Hepatitis B Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03083158
• Date of registration: 09/03/2017
• Prospective Registration: No
• Primary sponsor: University of British Columbia
• Public title: Immunity to Hepatitis B Vaccine HVP01
• Scientific 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
• Date of first enrolment: March 6, 2017
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03083158
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Manish Sadarangani
• Affiliation: University of British Columbia

• Name: Tobi Kollmann
• Affiliation: University of British Columbia

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Immunization; Infection

Hepatitis B

Intervention(s)

Drug: Hepatitis B vaccine

Primary Outcome(s)

Antibody response to the first dose of hepatitis B vaccine [Time Frame: 28 days post-vaccination following the first dose of vaccine]

Secondary Outcome(s)

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 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 transcriptomic response [Time Frame: Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination]

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]

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 lymph node response [Time Frame: Pre-vaccine and 14 days following first dose only]

Secondary ID(s)

H17-00175

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Scripps Research Institute

Vanderbilt University

Human Vaccines Project

Institut Pasteur

J. Craig Venter Institute

University of California, San Diego