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| Name | Class |
|---|---|
| Vanderbilt University | OTHER |
| J. Craig Venter Institute | OTHER |
| The Scripps Research Institute | OTHER |
| University of California, San Diego |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Older adults, aged 61-80 years |
|
| Group 2 | Other | Younger adults, aged 40-60 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis B vaccine | Drug | 1.0 ml (20 micrograms) suspension of hepatitis B surface antigen for intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody response to the first dose of hepatitis B vaccine | Anti-HBs antibody level | 28 days post-vaccination following the first dose of vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to cellular immune response | 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 | Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To correlate the 'omics immune responses measured after the first dose with antibody level after the 1st and 3rd doses | 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 | Days 1, 3, 7 and 14 post-first dose of vaccine and 28 days after the 1st and 3rd doses of vaccine |
Inclusion Criteria:
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
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| Name | Affiliation | Role |
|---|---|---|
| Manish Sadarangani | University of British Columbia | Principal Investigator |
| Tobi Kollmann | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccine Evaluation Center | Vancouver | British Columbia | V5Z 4H4 | Canada |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D007239 | Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| OTHER |
| Institut Pasteur | INDUSTRY |
| Human Vaccines Project | OTHER |
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| Kinetics of the immune response to the first dose of hepatitis B vaccine with respect to transcriptomic response | Gene expression by RNA sequencing of whole blood and single immune cells | 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 | Proteomic analysis of plasma and white blood cells | 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 | Metabolomic analysis of plasma | 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 | Epigenetic changes in genome | 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 | Immune responses in local lymph node, and comparison with peripheral blood responses | Pre-vaccine and 14 days following first dose only |
| Identify the DNA sequence of B- and T- cell receptors following vaccination | DNA sequencing of T- and B- cells | Baseline (pre-vaccine) and on days 1, 3, 7 and 14 post-vaccination |
| 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 | Correlation of gut, skin, buccal and nasal microbiota (obtained pre-vaccination) with HBV vaccine response. | 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 | Analysis of changes in gut, skin, buccal and nasal microbiota obtained following vaccination | Day 14 post-first dose of vaccine |
| The quality of the antibody response following hepatitis B vaccination, measured by antibody subclass and avidity | 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 | 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 | 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 | 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 |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |