Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Immune and Hormone Response to Influenza Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01978262
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : October 11, 2018
Last Update Posted : December 27, 2018
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Biological: Seasonal Inactivated Influenza Vaccine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study of the Immune Response to Influenza Vaccination and Effect on Reproductive Hormones
Study Start Date : October 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
healthy woman
All women are to receive the quadrivalent influenza vaccine
Biological: Seasonal Inactivated Influenza Vaccine
Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
Other Name: FluZone

Primary Outcome Measures :
  1. Change in Levels of Progesterone After Influenza Vaccination [ Time Frame: 2 months ]
    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.

Other Outcome Measures:
  1. Cytokine Effect on Reproductive Hormone Levels [ Time Frame: 2 months ]
    To explore whether inflammatory cytokine responses to IIV receipt are associated with changes in reproductive and stress hormone levels.

  2. Cytokine Responses to Influenza Vaccine [ Time Frame: 2 days ]
    Identify optimal biomarkers of the inflammatory response after vaccination.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01978262

Layout table for location information
United States, Maryland
Center for Immunization Research; Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Centers for Disease Control and Prevention
Layout table for investigator information
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
  Study Documents (Full-Text)

Documents provided by Johns Hopkins Bloomberg School of Public Health:
Statistical Analysis Plan  [PDF] January 24, 2018
Study Protocol  [PDF] January 24, 2018

Additional Information:
Layout table for additonal information
Responsible Party: Johns Hopkins Bloomberg School of Public Health Identifier: NCT01978262    
Other Study ID Numbers: CIR 292
200-2012-53664-002 ( Other Grant/Funding Number: CDC )
First Posted: November 7, 2013    Key Record Dates
Results First Posted: October 11, 2018
Last Update Posted: December 27, 2018
Last Verified: December 2018
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
influenza vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases