Immune Responses to the Flu Shot During Pregnancy

NCT02148874 | Completed Results

• 1 other identifier: 2008H0260
• Study Type: observational
• Target: 287
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

pregnant; flu shot; influenza; vaccine

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Infant HAI Antibody Titers

  cord blood at delivery

Study Arms (1)

Flu Shot

pregnant women receive a seasonal influenza virus vaccination

Biological: influenza virus vaccination

Interventions

influenza virus vaccination BIOLOGICAL

comparison of immune responses to the flu vaccine in obese and non-obese populations

Also known as: flu shot, influenza shot, flu vaccine

Flu Shot

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

community sample, prenatal clinic

You may qualify if:

• less than 29 weeks pregnant
• ages 18-42
• planning to deliver at The Ohio State University Wexner Medical Center

You may not qualify if:

• prior serious adverse reaction to seasonal influenza vaccine

Sponsors & Collaborators

• Lisa Christian: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43220, United States

Location

Related Publications (1)

• 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.

  PMID: 28778612 DERIVED

Related Links

• For more information or to apply

Biospecimen

Retention: SAMPLES WITH DNA

serum whole blood plasma

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Lisa Christian, PhD
• Organization: The Ohio State University Wexner Medical Center

lisa.christian@osumc.edu

614-293-0936

Study Officials

• Lisa M. Christian, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: May 28, 2014
• Study Start: October 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2019
• Last Updated: September 24, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-09

Locations

US (1)