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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
2
Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection
Stanford University School of Medicine
Stanford, California, United States
Plasma HAI Titer at Day 7 (Year 1)
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.
Time frame: Day 7 (after year 1 vaccine administration)
Number of Participants With Related Adverse Events (Year 1)
AEs related to IIV
Time frame: Baseline to Day 28 post year 1 vaccine administration
Number of Participants With Related Adverse Events (Year 2)
AEs to IIV
Time frame: Baseline to Day 28 post year 2 vaccine administration
Plasma HAI Titer at 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.
Time frame: Day 7 (Year 2)
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