Immune and Hormone Response to Influenza Vaccine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kawsar Talaat, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01978262
First received: October 24, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: Seasonal Inactivated Influenza Vaccine
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
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)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • A history of hypersensitivity, including anaphylaxis to any of the components of IIV or to eggs.
  • Previous receipt of a 2013-2014 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01978262

Locations
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
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Kawsar Talaat, Assistant Scientist, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01978262     History of Changes
Other Study ID Numbers: CIR 292, 200-2012-53664-002
Study First Received: October 24, 2013
Last Updated: March 10, 2014
Health Authority: United States: Centers for Disease Control and Prevention
United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
influenza vaccine
cytokines
hormones
progesterone

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014