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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Pilot Study of the Immune Response to Influenza Vaccination and Effect on Reproductive Hormones|
- Change in reproductive hormone levels after influenza vaccine [ Time Frame: 2 months ] [ Designated as safety issue: No ]To explore whether receipt of IIV during the second week of the menstrual cycle (i.e., the week prior to ovulation) is associated with changes in steroid hormone levels, particularly decreases in progesterone, following ovulation.
- Feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]To assess the feasibility of a larger study
- Cytokine responses to influenza vaccine [ Time Frame: 2 days ] [ Designated as safety issue: No ]Identify optimal biomarkers of the inflammatory response after vaccination.
- Cytokine effect on cortisol and reproductive hormone levels [ Time Frame: 2 months ] [ Designated as safety issue: No ]To explore whether inflammatory cytokine responses to IIV receipt are associated with changes in reproductive and stress hormone levels.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Quadrivalent influenza vaccine
all subjects to receive the inactivated quadrivalent influenza vaccine
Biological: Seasonal Inactivated Influenza Vaccine
Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
Other Name: FluZone
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 basal body temperature, estradiol, progesterone, and cortisol, 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 11 visits in addition to a screening visit, and will be followed for 2 complete menstrual cycles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978262
|United States, Maryland|
|Center for Immunization Research; Johns Hopkins Bloomberg School of Public Health|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Kawsar R Talaat, MD||Johns Hopkins Bloomberg School of Public Health|
|Principal Investigator:||Karen Broder, M.D.||Centers for Disease Control and Prevention|