Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers
Condition: Influenza; Influenza Immunisation
MeSH terms: Influenza, Human
Intervention: Influenza Virus Vaccine Inactivated
Intervention description: A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Trivalent influenza vaccine is formulated annually, based on influenza strains projected to be prevalent in the upcoming flu season.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ex-vivo; Healthy Volunteers; Immune Response; Influenza; plasmablasts; Vaccine

Summary:

      This was an open label, single arm, Phase IV study of longitudinal immunologic responses to
      influenza vaccine in healthy adult participants, with the aim of enrolling up to 70
      participants. This study enrolled males and non-pregnant females, 18-49 years old, inclusive.
      The participants were screened at enrollment with a history and physical exam and laboratory
      testing to ensure they were healthy enough to participate. Total enrollment was 60
      participants.

      Qualifying participants were vaccinated with an FDA approved seasonal inactivated influenza
      vaccine (IIV) according to the package insert. The study enrolled a total 60 participants.
      The primary objective of the study was to characterize HA-specific plasmablasts and memory B
      cells after influenza vaccination.

      Note: Due to the Coronavirus Disease 2019 (COVID-19) pandemic, all non-essential research was
      halted in mid-March 2020. New enrollments were placed on hold for this study. Follow-up
      visits were also halted, which impacted the timing of participants' subsequent follow-up
      visits. Five participants had their Day 180 visits halted due to the COVID-19 pandemic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18 and 49 years of age, inclusive.

          -  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.

          -  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:

               -  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 upper limit (uL), Female- 4-10 upper
                       limit (uL)

                    -  Platelet count: 150-400 upper limit (uL)

               -  Chemistries:

                    -  Kidney function: Glomerular filtration rate (GFR) > / = 60 mL/min/1.73 m^2;

                    -  Liver enzymes: Albumin > / = 3.5 g/dL; alanine aminotransferase (ALT) <66
                       U/L; aspartate aminotransferase (AST) <62 U/L

          -  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.

          -  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:

          -  Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
             hepatitis B virus (HBV). This information will be obtained verbally from the patient.

          -  If female, active pregnancy or breast-feeding or plans to become pregnant during study
             participation.

          -  Chronic medical conditions that cause immunodeficiency or that require medications
             which could alter immune function such as immunosuppressants and immunoenhancers.

          -  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

          -  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.

          -  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).

          -  Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other
             components of the study vaccine;

          -  Have a known latex allergy;

          -  Have a history of severe reactions following previous immunization with licensed
             influenza virus vaccines.

          -  Have a history of Guillain-Barre syndrome.

          -  Subjects who had or are suspected to have had an influenza infection in the current
             influenza season.

          -  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.

          -  Subjects who have already received the seasonal influenza vaccine in the current
             influenza vaccination season.