Pregnancy
Conditions
Keywords
pregnant, flu shot, influenza, vaccine
Brief summary
This study will examine effects of everyday life stress and obesity on immune responses to influenza virus vaccine (the flu shot) during pregnancy. Following vaccination, antibody levels against influenza (the flu) increase. Higher antibody levels indicate better immune protection from influenza. In addition to providing protection from the flu for yourself, being vaccinated during pregnancy may protect your baby from the flu during the first six months of life during which time infants cannot be vaccinated. Our primary goals are to determine whether greater life stress and obesity reduce 1) antibody responses to the flu shot in women and 2) antibody levels in the newborn at the time of delivery.
Interventions
BIOLOGICALinfluenza virus vaccination
comparison of immune responses to the flu vaccine in obese and non-obese populations
Sponsors
Lisa Christian
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
* less than 29 weeks pregnant * ages 18-42 * planning to deliver at The Ohio State University Wexner Medical Center
Exclusion criteria
* prior serious adverse reaction to seasonal influenza vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal HAI Antibody Titers | 30-days after influenza vaccination | Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant HAI Antibody Titers | cord blood at delivery | Infant influenza antibody titers from hemagglutination inhibition (HAI) assay |
Countries
United States
Participant flow
Recruitment details
We enrolled 287 pregnant women between October 2013 and March 2017 at The Ohio State University Wexner Medical Center. Participants were recruited through prenatal clinics at Ohio State, campus newsletters and advertisements, and community online advertisements.
Participants by arm
| Arm | Count |
|---|---|
| Non-Obese Pregnant women with a pre-pregnancy BMI 18.5-29.9. | 201 |
| Obese Pregnant women with a pre-pregnancy BMI 30.0-50.0 | 86 |
| Total | 287 |
Baseline characteristics
| Characteristic | Non-Obese | Obese | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 201 Participants | 86 Participants | 287 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 195 Participants | 82 Participants | 277 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 33 Participants | 71 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 150 Participants | 49 Participants | 199 Participants |
| Region of Enrollment United States | 201 participants | 86 participants | 287 participants |
| Sex: Female, Male Female | 201 Participants | 86 Participants | 287 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 201 | 0 / 86 |
| other Total, other adverse events | 0 / 201 | 0 / 86 |
| serious Total, serious adverse events | 0 / 201 | 0 / 86 |
Outcome results
Primary
Maternal HAI Antibody Titers
Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay
Time frame: 30-days after influenza vaccination
Population: Pregnant women with antibody titer data at 30 days post vaccination. Analyses include all women with available antibody titer data at the necessary time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Obese | Maternal HAI Antibody Titers | A/H1N1 Strain | 55.9 Titer |
| Non-Obese | Maternal HAI Antibody Titers | A/H3N2 Strain | 78.5 Titer |
| Non-Obese | Maternal HAI Antibody Titers | B/Massachusetts Strain | 17.3 Titer |
| Non-Obese | Maternal HAI Antibody Titers | B/Brisbane Strain | 17.8 Titer |
| Obese | Maternal HAI Antibody Titers | B/Brisbane Strain | 20.8 Titer |
| Obese | Maternal HAI Antibody Titers | A/H1N1 Strain | 59.8 Titer |
| Obese | Maternal HAI Antibody Titers | B/Massachusetts Strain | 22.3 Titer |
| Obese | Maternal HAI Antibody Titers | A/H3N2 Strain | 74.0 Titer |
Comparison: Statistical analysis for influenza strain A/H1N1.p-value: 0.8495% CI: [0.64, 1.73]Regression, Logistic
Comparison: Statistical analysis for influenza strain A/H3N2p-value: 0.7995% CI: [0.65, 1.75]Regression, Logistic
Comparison: Statistical analysis for influenza strain B/Massachusettsp-value: 0.4395% CI: [0.71, 2.24]Regression, Logistic
Comparison: Statistical analysis for influenza strain B/Brisbanep-value: 0.7795% CI: [0.63, 1.87]Regression, Logistic
Primary
Maternal HAI Antibody Titers
Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay
Time frame: at delivery
Population: Pregnant women with antibody titer data at delivery. Analyses include all women with available antibody titer data at the necessary time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Obese | Maternal HAI Antibody Titers | A/H1N1 Strain | 23.5 Titer |
| Non-Obese | Maternal HAI Antibody Titers | A/H3N2 Strain | 31.6 Titer |
| Non-Obese | Maternal HAI Antibody Titers | B/Massachusetts Strain | 10.3 Titer |
| Non-Obese | Maternal HAI Antibody Titers | B/Brisbane Strain | 8.4 Titer |
| Obese | Maternal HAI Antibody Titers | B/Brisbane Strain | 11.4 Titer |
| Obese | Maternal HAI Antibody Titers | A/H1N1 Strain | 32.5 Titer |
| Obese | Maternal HAI Antibody Titers | B/Massachusetts Strain | 16.3 Titer |
| Obese | Maternal HAI Antibody Titers | A/H3N2 Strain | 32.7 Titer |
Comparison: Statistical analysis for influenza strain A/H1N1p-value: 0.295% CI: [0.84, 2.32]Regression, Logistic
Comparison: Statistical analysis for influenza strain A/H3N2p-value: 0.7495% CI: [0.66, 1.8]Regression, Logistic
Comparison: Statistical analysis for influenza strain B/Massachusettsp-value: 0.0495% CI: [1.04, 3.44]Regression, Logistic
Comparison: Statistical analysis for influenza strain B/Brisbanep-value: 0.1395% CI: [0.87, 3.04]Regression, Logistic
Secondary
Infant HAI Antibody Titers
Infant influenza antibody titers from hemagglutination inhibition (HAI) assay
Time frame: cord blood at delivery
Population: Cord blood from participating pregnant women with cord blood data available. There was only one cord blood sample per participant in this study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Obese | Infant HAI Antibody Titers | B/Brisbane Strain | 128.8 Titer |
| Non-Obese | Infant HAI Antibody Titers | A/H3N2 Strain | 155.5 Titer |
| Non-Obese | Infant HAI Antibody Titers | A/H1N1 Strain | 95.4 Titer |
| Non-Obese | Infant HAI Antibody Titers | B/Massachusetts Strain | 139.0 Titer |
| Obese | Infant HAI Antibody Titers | A/H1N1 Strain | 78.4 Titer |
| Obese | Infant HAI Antibody Titers | B/Massachusetts Strain | 157.0 Titer |
| Obese | Infant HAI Antibody Titers | B/Brisbane Strain | 99.1 Titer |
| Obese | Infant HAI Antibody Titers | A/H3N2 Strain | 118.2 Titer |
Comparison: Statistical analysis for influenza strain A/H1N1p-value: 0.6495% CI: [0.53, 1.48]Regression, Logistic
Comparison: Statistical analysis for influenza strain A/H3N2p-value: 0.6795% CI: [0.53, 1.5]Regression, Logistic
Comparison: Statistical analysis for influenza strain B/Massachusettsp-value: 0.1495% CI: [0.88, 2.46]Regression, Logistic
Comparison: Statistical analysis for influenza strain B/Brisbanep-value: 0.2595% CI: [0.44, 1.24]Regression, Logistic