Immune Responses to the Flu Shot During Pregnancy

September 16, 2019 updated by: Lisa Christian
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

287

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43220
        • The Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

community sample, prenatal clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Flu Shot
pregnant women receive a seasonal influenza virus vaccination
Biological: influenza virus vaccination
comparison of immune responses to the flu vaccine in obese and non-obese populations
Other Names:
  • flu vaccine
  • flu shot
  • influenza shot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal HAI Antibody Titers
Time Frame: 30-days after influenza vaccination
Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay
30-days after influenza vaccination
Maternal HAI Antibody Titers
Time Frame: at delivery
Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay
at delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant HAI Antibody Titers
Time Frame: cord blood at delivery
Infant influenza antibody titers from hemagglutination inhibition (HAI) assay
cord blood at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisa Christian

Investigators

  • Principal Investigator: Lisa M. Christian, PhD, The Ohio State University Wexner Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (ESTIMATE)

May 28, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008H0260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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