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Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response (HIPCVAX-010S)

Primary Purpose

Influenza A Subtype H5N1 Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Seasonal Influenza Vaccine
Seasonal Influenza Vaccine
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Influenza A Subtype H5N1 Infection focused on measuring Immune response

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with and without AS03 Adjuvant study.
  • Capable of informed consent and provision of written informed consent before any study procedures.
  • Capable of attending all study visits according to the study schedule.
  • Are in good health, as determined by medical history and targeted physical exam related to this history.
  • Female subjects of childbearing age must have a negative urine pregnancy test before study vaccination, and must use at least one form of contraception to avoid pregnancy for 28 days before and 28 days after Fluarix Quadrivalent administration.

Exclusion Criteria:

  • Have an acute illness, including any fever (> 100.4 F [> 38 degrees C], regardless of the route) within 72 hours before vaccination.
  • Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
  • Alcohol or drug abuse and psychiatric conditions that, in the opinion of the investigator, would preclude compliance with the trial or interpretation of safety or endpoint data.
  • Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
  • Are pregnant or breastfeeding or plan to within one month of vaccination.
  • Have taken oral or parenteral corticosteroids of any dose within 28 days before study vaccination.
  • Have a known history of autoimmune disease.
  • Have a history of Guillain-Barre Syndrome.
  • Have a history of bleeding disorders.
  • Have known hypersensitivity or allergy to any component of the vaccine, including egg and latex allergies, or history of anaphylaxis with influenza vaccine or vaccine component.
  • Have received blood or blood products 3 months prior to study entry or expected to receive through 6 months after study entry.
  • Have received any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry.
  • Have received any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry.
  • Have received any experimental agents within 6 weeks prior to study or plan to through study duration.
  • Have received the 2018-2019 influenza seasonal vaccine.
  • Documented influenza infection during the 2018-2019 influenza season.
  • Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.

Sites / Locations

  • The Hope Clinic of Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Participants that received AS03 Adjuvant

Participants that did not receive AS03 Adjuvant

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)).
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.
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.

Full Information

First Posted
October 6, 2018
Last Updated
February 28, 2020
Sponsor
Emory University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03701061
Brief Title
Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response
Acronym
HIPCVAX-010S
Official Title
Human Immune Responses to an Adjuvanted H5 Vaccine: Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A Subtype H5N1 Infection
Keywords
Immune response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants that received AS03 Adjuvant
Arm Type
Experimental
Arm Description
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).
Arm Title
Participants that did not receive AS03 Adjuvant
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Seasonal Influenza Vaccine
Other Intervention Name(s)
Fluarix Quadrivalent
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Seasonal Influenza Vaccine
Other Intervention Name(s)
Fluarix Quadrivalent
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline (Day 1) before vaccination and Day 29 post vaccination
Secondary Outcome Measure Information:
Title
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
Description
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)).
Time Frame
up to Day 8 post vaccination
Title
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
Description
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.
Time Frame
Up to Day 29 post vaccination
Title
Number of Serious Adverse Events at Day 365 Among the Participants in Both Arms
Description
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.
Time Frame
Up to 365 days post vaccination

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with and without AS03 Adjuvant study. Capable of informed consent and provision of written informed consent before any study procedures. Capable of attending all study visits according to the study schedule. Are in good health, as determined by medical history and targeted physical exam related to this history. Female subjects of childbearing age must have a negative urine pregnancy test before study vaccination, and must use at least one form of contraception to avoid pregnancy for 28 days before and 28 days after Fluarix Quadrivalent administration. Exclusion Criteria: Have an acute illness, including any fever (> 100.4 F [> 38 degrees C], regardless of the route) within 72 hours before vaccination. Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination. Alcohol or drug abuse and psychiatric conditions that, in the opinion of the investigator, would preclude compliance with the trial or interpretation of safety or endpoint data. Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination. Are pregnant or breastfeeding or plan to within one month of vaccination. Have taken oral or parenteral corticosteroids of any dose within 28 days before study vaccination. Have a known history of autoimmune disease. Have a history of Guillain-Barre Syndrome. Have a history of bleeding disorders. Have known hypersensitivity or allergy to any component of the vaccine, including egg and latex allergies, or history of anaphylaxis with influenza vaccine or vaccine component. Have received blood or blood products 3 months prior to study entry or expected to receive through 6 months after study entry. Have received any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry. Have received any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry. Have received any experimental agents within 6 weeks prior to study or plan to through study duration. Have received the 2018-2019 influenza seasonal vaccine. Documented influenza infection during the 2018-2019 influenza season. Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Rouphael, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hope Clinic of Emory University
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response

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