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A Prospective Cohort Study to Examine Periconceptional Influenza Vaccination

Award Number: R03AI154544
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2023

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A Prospective Cohort Study to Examine Periconceptional Influenza Vaccination - 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 receive influenza vaccine around the time of conception.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$14,113 )
2024	2021	UNIVERSITY OF SAN FRANCISCO	2130 FULTON ST	SAN FRANCISCO	CA	94117	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	3	3/27/2024	NON-COMPETING CONTINUATION	-$14,113
														Subtotal = -$14,113

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	UNIVERSITY OF SAN FRANCISCO INC	2130 FULTON ST	SAN FRANCISCO	CA	94117	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	3	11/3/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	UNIVERSITY OF SAN FRANCISCO INC	2130 FULTON ST	SAN FRANCISCO	CA	94117	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	001	3	11/1/2021	NON-COMPETING CONTINUATION	$14,645
2022	2020	TEXAS A&M UNIVERSITY SYSTEM, THE	8441 RIVERSIDE PARKWAY BLDG 1 STE 3100	BRYAN	TX	77807	BRAZOS	USA	Allergy and Infectious Diseases Research	000	1	11/1/2021	NEW	-$14,645
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $75,032 )
2021	2021	UNIVERSITY OF SAN FRANCISCO INC	2130 FULTON ST	SAN FRANCISCO	CA	94117	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	002	3	6/17/2021	NON-COMPETING CONTINUATION	$74,982
2021	2020	TEXAS A&M UNIVERSITY SYSTEM, THE	8441 RIVERSIDE PARKWAY BLDG 1 STE 3100	BRYAN	TX	77807	BRAZOS	USA	Allergy and Infectious Diseases Research	000	1	5/15/2021	NEW	-$76,092
2021	2020	UNIVERSITY OF SAN FRANCISCO INC	2130 FULTON ST	SAN FRANCISCO	CA	94117	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	001	2	5/15/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$76,142
														Subtotal = $75,032

Issue Date FY: 2020 ( Subtotal = $90,737 )
2020	2020	TEXAS A&M UNIVERSITY SYSTEM, THE	8441 RIVERSIDE PARKWAY BLDG 1 STE 3100	BRYAN	TX	77807	BRAZOS	USA	Allergy and Infectious Diseases Research	000	1	6/30/2020	NEW	$90,737
2020	2020	TEXAS A&M UNIVERSITY SYSTEM, THE	8441 RIVERSIDE PARKWAY BLDG 1 STE 3100	BRYAN	TX	77807	BRAZOS	USA	Allergy and Infectious Diseases Research	001	1	8/24/2020	NEW	$0
														Subtotal = $90,737

Grand Total All Awards = $151,656

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A Prospective Cohort Study to Examine Periconceptional Influenza Vaccination

Award Number: R03AI154544

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2023

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