Atlanta, Georgia 30322


Purpose:

This is an open label single arm observational study of longitudinal immunologic responses to influenza vaccine in healthy adult subjects. This study will enroll males and non-pregnant females, 18-49 years old. The subjects will be screened at enrollment with a history and physical exam and laboratory testing to ensure they are healthy enough to participate. Qualifying subjects will be vaccinated with an FDA approved seasonal inactivated influenza vaccine (IIV) according to the package insert. The study will enroll 10 healthy volunteers per vaccination season in years 1, 2 and 4 through 6 of this study, for a total enrollment of 50 subjects. The primary objective of the study is to characterize HA-specific plasmablasts and memory B cells after influenza vaccination.


Study summary:

This is an open label, single arm, observational study of longitudinal immunologic responses to influenza vaccine in healthy adult subjects. This study will enroll males and non-pregnant females, 18-49 years old. The study duration is 6 years and participant duration of 180 days. The subjects will be screened at enrollment with a history and physical exam and laboratory testing to ensure they are healthy enough to participate. Qualifying subjects will be vaccinated with an FDA approved seasonal inactivated influenza vaccine (IIV) according to the package insert. Approximately 450 ml of blood will be collected for the research assays during the course of the study. Specifically, 16 ml will be collected for screening; 48ml will be collected at enrollment; 96ml will be collected at visit days 7 and 14; and 64 ml will be collected at 28, 90, and 180 days post vaccination. The study will enroll 10 healthy volunteers per vaccination season in years 1, 2, and 4 through 6 of this study, for a total enrollment of 50 subjects. Individuals who complete the study will be given the option to re-enroll in subsequent years as long as they continue to meet all inclusion/exclusion criteria. Re-enrolling subjects will be re-consented, given new subject identifiers, and counted towards the enrollment number goal for each year of participation. The primary objective of the study is to characterize HA-specific plasmablasts and memory B cells after influenza vaccination and secondary objective investigate the longevity of humoral immunity to influenza virus in humans.


Criteria:

Inclusion Criteria: 1. Male or female subjects between 18 and 49 years of age, inclusive 2. Subjects capable of providing written informed consent prior to initiation of any study procedures. Subjects able to understand and comply with planned study procedures and be available for all study visits 3. Screening labs within normal limits per the local laboratory normal ranges or considered to be not clinically significant by the investigator. Normal laboratory ranges are as listed below: A. Hematology: - Hemoglobin: Male- 12.9-16.1 gm/dL, Female- 11.4-14.4 gm/dL - White blood cells (WBC): Male- 4.2-9.2/uL, Female- 4-10/uL - Platelet count: 150-400/uL B. Chemistries: - Kidney function:Glomerular filtration rate (GFR) >/= 60 mL/min/1.73 m^2; - Liver enzymes: Albumin >/= 3.5 g/dL; ALT <66 U/L; AST <62 U/L 4. Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season. 5. Female subjects of child bearing potential must have a negative urine pregnancy test at the screening visit, enrollment visit and all subsequent study visits longer than 14 days since the last pregnancy test. Exclusion Criteria: 1. Known infection with HIV, HCV, or HBV. This information will be obtained verbally from the patient. 2. If female, active pregnancy or breast-feeding or plans to become pregnant during study participation. 3. Chronic medical conditions that cause immunodeficiency or that require medications which could alter immune function such as immunosuppressants and immunoenhancers. 4. Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation. This includes any chronic medical disease or condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study 5. Have an acute illness, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. 6. Persons taking anticoagulants, long-term aspirin therapy, or long-term systemic steroids (greater than 3 months in the past 12 months and any within 30 days). 7. Have known hypersensitivity or allergy to eggs, egg or chicken protein or other components of the study vaccine; 8. Have a known latex allergy; 9. Have a history of severe reactions following previous immunization with licensed influenza virus vaccines 10. Have a history of Guillain-Barre syndrome 11.Subjects who had or are suspected to have had an influenza infection in the current influenza season 12. Subjects who, at screening, have abnormal vital signs and/or physical exam, including a temperature >= 38.0 C, Systolic blood pressure <=90 or >=160 mmHg, pulse <= 60 or > 110 beats per minute, new rash, signs of infection. 13. Subjects who have already received the seasonal influenza vaccine in the current influenza vaccination season.


NCT ID:

NCT02385123


Primary Contact:

Aneesh K Mehta
Phone: 14047278435
Email: aneesh.mehta@emory.edu


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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