Immune and Hormone Response to Influenza Vaccine
Immune and Hormone Response to Influenza Vaccine
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
This study is an open-label, longitudinal study of healthy young women of reproductive age,
 not on hormonal contraception who receive seasonal inactivated influenza vaccine (IIV). The
 women will be followed for one menstrual cycle to measure luteinizing hormone surge,
 estradiol, and progesterone, and then vaccinated with the seasonal inactivated influenza
 vaccine prior to ovulation during a second month. At the investigator's discretion, or if
 there is active circulation of influenza virus in Baltimore, the investigators will vaccinate
 during the first menstrual cycle (prior to ovulation) and then follow for a second menstrual
 cycle for comparison. After vaccination, they will be followed for cytokine and chemokine
 responses as well as changes in the concentrations of steroid hormones. This study will
 evaluate the effect of IIV on inflammatory cytokines and hormonal responses before and after
 ovulation. Each woman will have 13 visits in addition to a screening visit, and will be
 followed for 2 complete menstrual cycles.
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.