Response to Influenza Vaccine During Pregnancy
Overview
- Phase
- Phase 1
- Intervention
- Quadrivalent inactivated influenza vaccine (IIV)
- Conditions
- Influenza
- Sponsor
- Stanford University
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Plasma HAI Titer at Day 7 (Year 1)
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to vaccination in pregnancy.
Detailed Description
This is a Phase I mechanistic study of licensed influenza vaccines with up to 50 pregnant female volunteers, 18-49 years of age. Investigator intends to collect blood from pregnant women and then from the same women a year later when they are not pregnant after routine seasonal influenza vaccination. By studying the blood of immunized pregnant women and in these same women after pregnancy, the investigator will gain a better understanding of the immune response to vaccination in pregnancy and after pregnancy. Each volunteer will participate for approximately 4 weeks including enrollment, vaccination, and completion of sample collection in 2 consecutive flu seasons. The Study has a total of 6 visits over 2 Flu seasons. Study procedures: Year One: First Visit: Procedures during this visit are: Informed consent process, enrollment, study assessments, 20 ml blood draw, and vaccination. 2nd and 3rd visits: 20 ml blood will be obtained Year Two: First Visit: Study assessments, 20 ml blood draw, and vaccination. 2nd and 3rd visits: 20 ml blood will be obtained
Investigators
Philip Grant
Assistant Professor of Medicine (Infectious Diseases)
Stanford University
Eligibility Criteria
Inclusion Criteria
- •18-49-year-old pregnant woman
- •Willing and able to complete the informed consent process
- •Availability for follow-up for the planned duration of the study with the expected delivery date more than 28 days after vaccination
- •Acceptable medical history by review of inclusion/exclusion criteria
Exclusion Criteria
- •Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
- •Life-threatening reactions to previous influenza vaccinations
- •Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, or arginine.
- •Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- •History of immunodeficiency (including HIV infection)
- •Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
- •Chronic Hepatitis B or C.
- •Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (\<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
- •Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- •Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol.
Arms & Interventions
Study Phase
Participants will be given the current year's quadrivalent inactivated influenza vaccine (IIV)
Intervention: Quadrivalent inactivated influenza vaccine (IIV)
Outcomes
Primary Outcomes
Plasma HAI Titer at Day 7 (Year 1)
Time Frame: Day 7 (after year 1 vaccine administration)
HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.
Plasma HAI Titer at Day 7 (Year 2)
Time Frame: Day 7 (Year 2)
HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.
Number of Participants With Related Adverse Events (Year 1)
Time Frame: Baseline to Day 28 post year 1 vaccine administration
AEs related to IIV
Number of Participants With Related Adverse Events (Year 2)
Time Frame: Baseline to Day 28 post year 2 vaccine administration
AEs to IIV