Influenza Clinical Trial
— FLU2Official title:
The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics
Verified date | June 2022 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to understand the impact on the human immune system's response to the four strain flu vaccine in individuals who have "imprinted" on specific influenza strains. It will also consider the effects of repeated prior annual influenza vaccination on the immune system.
Status | Terminated |
Enrollment | 39 |
Est. completion date | June 20, 2020 |
Est. primary completion date | June 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 42 Years to 71 Years |
Eligibility | Inclusion Criteria: 1. Capable of informed consent and provision of written informed consent before any study procedures. 2. Capable of attending all study visits according to the study schedule. 3. Males or females born between 1968-1977 or 1948-1957. 4. Are in good health, as determined by medical history and targeted physical exam related to this history. 5. Oral temperature is less than 38 degrees Celsius. 6. Resting pulse rate is between 50 and 100 beats per minute. 7. Female subjects of childbearing age must have a negative urine pregnancy test within 24 hours before study vaccination. 8. Have received the influenza vaccine at least 3 of the past 5 years or have received the influenza vaccine in 2 or less of the past 5 years. Exclusion Criteria: 1. Have an acute illness within 72 hours before vaccination. 2. Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of harm or confound the interpretation of the study results. 3. 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. 4. Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination. 5. Have known HIV, hepatitis B, or hepatitis C infection. 6. Have a known history of autoimmune disease. 7. Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination. 8. Have taken high-dose inhaled corticosteroids within 30 days before study vaccination. 9. Have received, or plan to receive, any licensed live vaccine within 30 days, or any licensed inactivated vaccine within 14 days, prior to, or after, study vaccination. 10. Have planned receipt of any unlicensed or investigational medications, biologics, or vaccines for the duration of subject study participation. 11. Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination. 12. Have donated blood or blood products within 30 days before study vaccination, or within 60 days after study vaccination, or plan to donate blood within 30 days of the last blood draw. 13. Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other compounds of the study vaccine. 14. Have a history of severe reactions following vaccination with influenza virus vaccines. |
Country | Name | City | State |
---|---|---|---|
United States | The Hope Clinic of the Emory Vaccine Center | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Sherman AC, Lai L, Bower M, Natrajan MS, Huerta C, Karmali V, Kleinhenz J, Xu Y, Rouphael N, Mulligan MJ. The Effects of Imprinting and Repeated Seasonal Influenza Vaccination on Adaptive Immunity after Influenza Vaccination. Vaccines (Basel). 2020 Nov 7; — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Number of Participants Achieving Seroprotection Against Each Strain | Seroprotection against each strain contained in the seasonal quadrivalent influenza vaccine (A/H1N1, A/H3N2, B/Phuket, and B/Colorado) were measured by hemagglutination inhibition (HAI) antibody response. Seroprotection is defined as a titer of = 40. | 28 days after vaccination | |
Primary | The Number of Participants Achieving Seroconversion Against Each Strain | Seroconversion against each strain contained in the seasonal quadrivalent influenza vaccine was measured by HAI antibody response. Seroconversion is defined as a four-fold rise in HAI post- compared to pre-vaccination, or a titer of =40 if the pre-vaccination titer was <10. | 28 days after vaccination | |
Primary | Geometric Mean Titers (GMTs) of Serum HAI Against Each Strain | The geometric scale is logarithmic. A geometric mean is calculated by averaging the logarithms of the test values and then converting the mean to a real number. | 28 days after vaccination | |
Secondary | The Proportion of Participants Achieving Seroprotection or Seroconversion Against Each Strain Measured by Neutralizing Antibody (NAb) Response | Seroprotection/seroconversion against each strain contained in the seasonal quadrivalent influenza vaccine will be measured by neutralizing antibody (NAb) response. The proportion of subjects achieving seroprotection (titer of = 40) or seroconversion (four-fold rise in NAb post- compared to pre-vaccination, or a titer of =40 if the pre-vaccination titer was <10) against each strain will be assessed. | 28 days after vaccination | |
Secondary | Geometric Mean Titers (GMTs) of Serum NAb Against Each Strain | The geometric scale is logarithmic. A geometric mean is calculated by averaging the logarithms of the test values and then converting the mean to a real number. | 28 days after vaccination | |
Secondary | The Number of Participants Achieving Seroprotection Against Each Strain | Seroprotection against each strain contained in the seasonal quadrivalent influenza vaccine (A/H1N1, A/H3N2, B/Phuket, and B/Colorado) were measured by hemagglutination inhibition (HAI) antibody response. Seroprotection is defined as a titer of = 40. | 180 days after vaccination | |
Secondary | The Number of Participants Achieving Seroconversion Against Each Strain | Seroconversion against each strain contained in the seasonal quadrivalent influenza vaccine was measured by HAI antibody response. Seroconversion is defined as a four-fold rise in HAI post- compared to pre-vaccination, or a titer of =40 if the pre-vaccination titer was <10. | 180 days after vaccination | |
Secondary | Geometric Mean Titers (GMTs) of Serum HAI Against Each Strain | The geometric scale is logarithmic. A geometric mean is calculated by averaging the logarithms of the test values and then converting the mean to a real number. | 180 days after vaccination | |
Secondary | The Proportion of Participants Achieving Seroprotection or Seroconversion Against Each Strain Measured by NAb Response | Seroprotection/seroconversion against each strain contained in the seasonal quadrivalent influenza vaccine will be measured by NAb antibody response. | 180 days after vaccination | |
Secondary | Geometric Mean Titers (GMTs) of Serum NAb Against Each Strain | The geometric scale is logarithmic. A geometric mean is calculated by averaging the logarithms of the test values and then converting the mean to a real number. | 180 days after vaccination |
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