Influenza
Conditions
Keywords
Influenza, Pregnancy, Quadrivalent inactivated influenza vaccine (IIV).
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
Interventions
Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection
Sponsors
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18-49-year-old pregnant woman 2. Willing and able to complete the informed consent process 3. Availability for follow-up for the planned duration of the study with the expected delivery date more than 28 days after vaccination 4. Acceptable medical history by review of inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma HAI Titer at Day 7 (Year 1) | 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. |
| Number of Participants With Related Adverse Events (Year 1) | Baseline to Day 28 post year 1 vaccine administration | AEs related to IIV |
| Number of Participants With Related Adverse Events (Year 2) | Baseline to Day 28 post year 2 vaccine administration | AEs to IIV |
| Plasma HAI Titer at Day 7 (Year 2) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inactivated Influenza Vaccine Participants received the annual IIV | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Inactivated Influenza Vaccine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 29 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Number of Participants With Related Adverse Events (Year 1)
AEs related to IIV
Time frame: Baseline to Day 28 post year 1 vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Received IIV | Number of Participants With Related Adverse Events (Year 1) | 0 Participants |
Primary
Number of Participants With Related Adverse Events (Year 2)
AEs to IIV
Time frame: Baseline to Day 28 post year 2 vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Received IIV | Number of Participants With Related Adverse Events (Year 2) | 0 Participants |
Primary
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)
Population: Data were not collected for this outcome measure.
Primary
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)
Population: Data were not collected for this outcome measure.