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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flu Shot | pregnant women receive a seasonal influenza virus vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| influenza virus vaccination | Biological | comparison of immune responses to the flu vaccine in obese and non-obese populations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal HAI Antibody Titers | Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay | 30-days after influenza vaccination |
| Maternal HAI Antibody Titers | Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay | at delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Infant HAI Antibody Titers | Infant influenza antibody titers from hemagglutination inhibition (HAI) assay | cord blood at delivery |
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Inclusion Criteria:
Exclusion Criteria:
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community sample, prenatal clinic
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M. Christian, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28778612 | Derived | Christian LM, Beverly C, Mitchell AM, Karlsson E, Porter K, Schultz-Cherry S, Ramilo O. Effects of prior influenza virus vaccination on maternal antibody responses: Implications for achieving protection in the newborns. Vaccine. 2017 Sep 18;35(39):5283-5290. doi: 10.1016/j.vaccine.2017.05.050. Epub 2017 Aug 1. |
| Label | URL |
|---|---|
| For more information or to apply | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Obese | Pregnant women with a pre-pregnancy BMI 18.5-29.9. |
| FG001 | Obese | Pregnant women with a pre-pregnancy BMI 30.0-50.0 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Obese | Pregnant women with a pre-pregnancy BMI 18.5-29.9. |
| BG001 | Obese | Pregnant women with a pre-pregnancy BMI 30.0-50.0 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal HAI Antibody Titers | Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 30-days after influenza vaccination |
|
Adverse event data were collected from enrollment up until delivery of the infant. This time frame varied from 3-8 months depending on gestational age at enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Obese | Pregnant women with a pre-pregnancy BMI 18.5-29.9. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Christian, PhD | The Ohio State University Wexner Medical Center | 614-293-0936 | lisa.christian@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2016 | Jul 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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serum whole blood plasma
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Maternal HAI Antibody Titers | Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay | Pregnant women with antibody titer data at delivery. Analyses include all women with available antibody titer data at the necessary time points. | Posted | Geometric Mean | 95% Confidence Interval | Titer | at delivery |
|
|
|
|
| Secondary | Infant HAI Antibody Titers | Infant influenza antibody titers from hemagglutination inhibition (HAI) assay | Cord blood from participating pregnant women with cord blood data available. There was only one cord blood sample per participant in this study. | Posted | Geometric Mean | 95% Confidence Interval | Titer | cord blood at delivery |
|
|
|
|
| 201 |
| 0 |
| 201 |
| 0 |
| 201 |
| EG001 | Obese | Pregnant women with a pre-pregnancy BMI 30.0-50.0. | 0 | 86 | 0 | 86 | 0 | 86 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| B/Massachusetts Strain |
|
| B/Brisbane Strain |
|
| Statistical analysis for influenza strain A/H3N2 | Regression, Logistic | Cumulative logistic regression model | 0.74 | Odds Ratio (OR) | 1.09 | 2-Sided | 95 | 0.66 | 1.80 | Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N). | Superiority |
| Statistical analysis for influenza strain B/Massachusetts | Regression, Logistic | Cumulative logistic regression model | 0.04 | Odds Ratio (OR) | 1.89 | 2-Sided | 95 | 1.04 | 3.44 | Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N). | Superiority |
| Statistical analysis for influenza strain B/Brisbane | Regression, Logistic | Cumulative logistic regression model | 0.13 | Odds Ratio (OR) | 1.63 | 2-Sided | 95 | 0.87 | 3.04 | Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N). | Superiority |
| B/Massachusetts Strain |
|
| B/Brisbane Strain |
|
| Statistical analysis for influenza strain A/H3N2 | Regression, Logistic | Cumulative logistic regression model | 0.67 | Odds Ratio (OR) | 0.89 | 2-Sided | 95 | 0.53 | 1.50 | Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N). | Superiority |
| Statistical analysis for influenza strain B/Massachusetts | Regression, Logistic | Cumulative logistic regression model | 0.14 | Odds Ratio (OR) | 1.47 | 2-Sided | 95 | 0.88 | 2.46 | Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N). | Superiority |
| Statistical analysis for influenza strain B/Brisbane | Regression, Logistic | Cumulative logistic regression model | 0.25 | Odds Ratio (OR) | 0.74 | 2-Sided | 95 | 0.44 | 1.24 | Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N). | Superiority |