# A prospective cohort study to examine periconceptional influenza vaccination

> **NIH NIH R03** · TEXAS A&M UNIVERSITY HEALTH SCIENCE CTR · 2020 · $14,645

## Abstract

PROJECT SUMMARY
Pregnant women are up to five times more likely to be hospitalized with influenza than non-pregnant women,
and young infants are more than four times as likely as older children to die from influenza. To protect pregnant
women and their infants, the American College of Obstetricians and Gynecologists recommends that all
women who are or will be pregnant during influenza season should receive an influenza vaccine. Based on
current recommendations, influenza vaccination is currently part of standard prenatal care. Despite these
recommendations and the demonstrated health benefits of prenatal vaccination, fewer than 40% of mothers
are vaccinated during pregnancy, and vaccination rates are especially low during early pregnancy. Concerns
for the safety of vaccination on pregnancy-related outcomes are commonly cited as contributing factors to this
low rate of immunization.
Few studies have evaluated the risk of spontaneous abortion (SAB) associated with influenza vaccination, a
pregnancy outcome which may be a particular concern for women planning pregnancy or in the first trimester
of their pregnancy. To date, what studies have been conducted have had major methodological flaws.
Furthermore, no study has yet evaluated the impacts of paternal exposure to influenza vaccines or the health
effects of pre-conception vaccination. Limited evidence in this area can present challenges to parents and their
providers while making decisions on vaccination, thereby reducing public confidence in vaccination around the
time of conception. This has been demonstrated by the lower confidence reported by physicians when
recommending vaccination for women in their first trimester.
A common limitation to existing vaccine studies is that recruitment begins during pregnancy, meaning that
women in the earliest stages of pregnancy who are at highest risk of SAB and are less likely to be vaccinated
are not included in these studies. This study aims to analyze data from a cohort of women and their partners
recruited prior to conception in order to evaluate the association between the risk of spontaneous abortion and
influenza vaccination during the weeks prior to and after conception. This study will consider both maternal and
paternal vaccination as well as the number of vaccinations received in the previous year. To address this, the
research team plans to analyze data from 11,150 female and 2,540 male participants of the Pregnancy Study
Online (PRESTO) cohort, a North American prospective preconception cohort study.
Influenza vaccination is currently considered the optimal strategy for protecting pregnant women and their
infants against influenza. Using data from a large, cohort of women and their male partners, this application will
address an important issue for prenatal care in the US and other countries. Study results will be useful to
clinicians when evaluating whether to make vaccine recommendations and by families in their decision-making
on whether to...

## Key facts

- **NIH application ID:** 10042685
- **Project number:** 1R03AI154544-01
- **Recipient organization:** TEXAS A&M UNIVERSITY HEALTH SCIENCE CTR
- **Principal Investigator:** Annette Karena Regan
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $14,645
- **Award type:** 1
- **Project period:** 2020-07-01 → 2020-07-02

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10042685

## Citation

> US National Institutes of Health, RePORTER application 10042685, A prospective cohort study to examine periconceptional influenza vaccination (1R03AI154544-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10042685. Licensed CC0.

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