Immune and Hormone Response to Influenza Vaccine

This is an interventional other trial for Healthy focused on measuring influenza vaccine, cytokines, hormones, progesterone Read More

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.