Immune and Hormone Response to Influenza Vaccine
Condition: Healthy
MeSH terms: Influenza, Human
Intervention: Seasonal Inactivated Influenza Vaccine
Intervention description: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza vaccine; cytokines; hormones; progesterone

Summary:

      The purpose of this pilot research project is to look at the effect of the inactivated
      influenza vaccine (seasonal flu shot) on early signs of immune or germ-fighting response
      known as cytokines or signal molecules. The investigators also want to see if the timing of
      vaccine administration has any effect on women's reproductive hormones. The investigators
      hypothesis is that influenza vaccine given right before ovulation may change the hormone
      levels usually seen after ovulation. Thi
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18-39 years of age who are in good health.

          -  Good general health as a result of review of medical history and/or clinical testing
             at the time of screening.

          -  Available for the duration of the trial.

          -  Willingness to participate in the study as evidenced by signing the informed consent
             document.

          -  Willing to be abstinent or to use non-hormonal methods of contraception for the
             duration of the study.

          -  History of normal menstrual cycles (26-35 days in length) for at least 3 months.

          -  Willingness to refrain from routine vaccination (except as administered during study)
             for the duration of the study.

        Exclusion Criteria:

          -  Use of contraceptive pills, patch, injection or other hormonal therapies in the
             preceding 3 months (6 months for DepoProvera)

          -  A history of hypersensitivity, including anaphylaxis to any of the components of IIV
             or to eggs.

          -  Previous receipt of a same season licensed influenza vaccine.

          -  Pregnancy as determined by a positive urine or serum human choriogonadotropin (β-hCG)
             test at any point during the study or in the preceding 3 months.

          -  Currently is lactating or breast-feeding.

          -  Fewer than 3 normal menstrual cycles since conclusion of last pregnancy or last use of
             hormonal birth control.

          -  A history of autoimmune disease, or any other chronic medical condition considered
             clinically significant by the investigator.

          -  History of HIV, Hepatitis C or active Hepatitis B.

          -  Known immunodeficiency syndrome.

          -  History of Guillain-Barré syndrome.

          -  Use of chronic oral or intravenous administration (≥14 days) of immunosuppressive
             doses of steroids, i.e., prednisone >10 mg per day, immunosuppressants or other
             immune-modifying drugs within 30 days of starting this study. (Use of topical, nasal
             or inhaled steroids is permitted)

          -  Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to
             study start or during study.

          -  Receipt of blood or blood-derived products (including immunoglobulin) within 6 months
             prior to study vaccination.

          -  Receipt of another investigational vaccine or drug within 30 days prior to study
             start, or during study.

          -  Ongoing, daily use of analgesics or anti-inflammatory medications, including
             nonsteroidal anti-inflammatories. Occasional use, and use associated with menstrual
             periods is acceptable.