Immune and Hormone Response to Influenza Vaccine

Completed · Phase 4

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01978262

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

103

Starts

2013-10-01

Expected to finish

2017-08-01

Last updated by the study team

2018-12-27

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Immunization Research; Johns Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.