NCT01978262

Immune and Hormone Response to Influenza Vaccine

A Pilot Study of the Immune Response to Influenza Vaccination and Effect on Reproductive Hormones

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Seasonal Inactivated Influenza Vaccine	Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2013-11-07
• Last updated: 2018-12-27
• Results posted: 2018-10-11

Locations

1 site across 1 country: United States