Immune and Hormone Response to Influenza Vaccine

NCT01978262 | Completed Phase 4 Results

• 2 other identifiers: CIR 292200-2012-53664-002
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

influenza vaccine; cytokines; hormones; progesterone

Outcome Measures

Primary Outcomes (1)

• Change in Levels of Progesterone After Influenza Vaccination

  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.

  2 months

Other Outcomes (2)

• Cytokine Effect on Reproductive Hormone Levels

  2 months

• Cytokine Responses to Influenza Vaccine

  2 days

Study Arms (1)

healthy woman

OTHER

All women are to receive the quadrivalent influenza vaccine

Biological: Seasonal Inactivated Influenza Vaccine

Interventions

Seasonal Inactivated Influenza Vaccine BIOLOGICAL

Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly

Also known as: FluZone

healthy woman

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Center for Immunization Research; Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Links

• Center for Immunization Research Website
• Click here for information about enrolling in this study

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Kawsar Talaat
• Organization: Johns Hopkins University

ktalaat@jhu.edu

410-502-9627

Study Officials

• Kawsar R Talaat, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Karen Broder, M.D.

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 7, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 27, 2018
• Results First Posted: October 11, 2018

Record last verified: 2018-12

Locations

US (1)