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| ID | Type | Description | Link |
|---|---|---|---|
| U19AI090023 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The study is a prospective single site exploratory study to examine the impact of Food and Drug Administration (FDA) approved seasonal flu vaccine on the immune responses of H5N1 vaccine previously received with or without the AS03 adjuvant.
Influenza, caused by the influenza virus, is a contagious respiratory disease that can result in mild to severe illness. It is estimated that up to 80,000 deaths and approximately 200,000 Americans are hospitalized annually due to complications. Vaccination is the most effective way of controlling flu and preventing its illness and complications; however, antibody responses to seasonal influenza vaccines decrease over time and only target a small number of antibody binding sites In 2015, the Hope Clinic of the Emory Vaccine Center completed a study analyzing human immune responses to a pandemic H5N1, or "bird flu" vaccine, either alone or combined with the GlaxoSmithKline adjuvant system 03 (AS03).
Participants that took part in the 2013 HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with and without AS03 Adjuvant study will be enrolled in this study to assess the effect of seasonal influenza vaccine in shaping the immune responses. The study aims to address important immunological mechanisms that can assist scientists in the creation of a universal influenza vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants that received AS03 Adjuvant | Experimental | Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent). |
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| Participants that did not receive AS03 Adjuvant | Active Comparator | Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seasonal Influenza Vaccine | Biological | A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Four-fold Increase in Stem-specific Antibody Titers (H5, Hemagglutinin Antibody) Against H5N1 at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among All the Participants in Both Arms | Antibody Titers (hemagglutinin inhibition antibody titers) are measured through immunologic assays from blood draw at Baseline (Day1) before study vaccination and are repeated on Day 29. Participants with four fold increase in titer levels will be recorded. | Baseline (Day 1) before vaccination and Day 29 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Solicited (AE's) Grade 2 and Above at Day 8 After Vaccination With the Seasonal Influenza Vaccine Among the Participants in Both Arms | To evaluate safety, grade 2 and above solicited AE's are recorded from Day 1 post vaccination to Day 8 post vaccination.Solicited adverse events include local (pain, erythema and induration) and systemic (chills, loss of appetite, headache, fatigue, myalgia, arthralgia, nausea, fever (body temperature ≥ 38°C (100.4°F)). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadine Rouphael, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hope Clinic of Emory University | Decatur | Georgia | 30030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants That Received AS03 Adjuvant | Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent). Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study |
| FG001 | Participants That Did Not Receive AS03 Adjuvant | Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent). Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants That Received AS03 Adjuvant | Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 Adjuvant study (NCT01910519) are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent). Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Four-fold Increase in Stem-specific Antibody Titers (H5, Hemagglutinin Antibody) Against H5N1 at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among All the Participants in Both Arms | Antibody Titers (hemagglutinin inhibition antibody titers) are measured through immunologic assays from blood draw at Baseline (Day1) before study vaccination and are repeated on Day 29. Participants with four fold increase in titer levels will be recorded. | Posted | Count of Participants | Participants | Baseline (Day 1) before vaccination and Day 29 post vaccination |
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from Day 1 post vaccination to Day 365 post vaccination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants That Received AS03 Adjuvant | Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent). Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadine Rouphael | Emory University | 404-712-1435 | nroupha@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2018 | Jan 29, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2018 | Feb 4, 2020 | Prot_SAP_001.pdf |
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Prospective, Exploratory study with up to 50 subjects total, who previously participated in the HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with and without AS03 Adjuvant study
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| Seasonal Influenza Vaccine | Biological | A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study |
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| up to Day 8 post vaccination |
| Number of Unsolicited Adverse Events (AE's) Grade 2 and Above at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among the Participants in Both Arms | To evaluate safety, grade 2 and above unsolicited AE's are recorded from Day 1 post vaccination to Day 29 post vaccination. Unsolicited AE information is volunteered or noted in an unsolicited manner and not as a required data element through a case report form. | Up to Day 29 post vaccination |
| Number of Serious Adverse Events at Day 365 Among the Participants in Both Arms | Serious adverse events are recorded from Day 1 post vaccination to Day 365 post vaccination. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, or is considered an "other important medical event" based on medical judgement. | Up to 365 days post vaccination |
| BG001 | Participants That Did Not Receive AS03 Adjuvant | Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study (NCT01910519) are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent). Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Participants That Did Not Receive AS03 Adjuvant | Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent). Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study |
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| Secondary | Number of Solicited (AE's) Grade 2 and Above at Day 8 After Vaccination With the Seasonal Influenza Vaccine Among the Participants in Both Arms | To evaluate safety, grade 2 and above solicited AE's are recorded from Day 1 post vaccination to Day 8 post vaccination.Solicited adverse events include local (pain, erythema and induration) and systemic (chills, loss of appetite, headache, fatigue, myalgia, arthralgia, nausea, fever (body temperature ≥ 38°C (100.4°F)). | Posted | Number | number of events | up to Day 8 post vaccination |
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| Secondary | Number of Unsolicited Adverse Events (AE's) Grade 2 and Above at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among the Participants in Both Arms | To evaluate safety, grade 2 and above unsolicited AE's are recorded from Day 1 post vaccination to Day 29 post vaccination. Unsolicited AE information is volunteered or noted in an unsolicited manner and not as a required data element through a case report form. | Posted | Number | number of events | Up to Day 29 post vaccination |
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| Secondary | Number of Serious Adverse Events at Day 365 Among the Participants in Both Arms | Serious adverse events are recorded from Day 1 post vaccination to Day 365 post vaccination. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, or is considered an "other important medical event" based on medical judgement. | Posted | Number | number of events | Up to 365 days post vaccination |
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| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Participants That Did Not Receive AS03 Adjuvant | Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent). Seasonal Influenza Vaccine: A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study | 0 | 3 | 0 | 3 | 0 | 3 |
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