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Optimization of Antibiotics in Mothers and their Breastfed Infants Using Pharmacomicrobiomic and Metabolomic Analyses

Award Number: P50HD106463
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Optimization of Antibiotics in Mothers and their Breastfed Infants Using Pharmacomicrobiomic and Metabolomic Analyses - Project Summary/Abstract Pregnant people are particularly vulnerable to SARS-CoV-2 and at risk of developing a more serious or complicated disease course, including about a 70% increased risk of death. Infection in pregnancy also appears to be related to increased risk for preterm delivery as well as other adverse pregnancy outcomes, such as stillbirth. For this reason, pregnant people are considered a priority population for vaccination. Limitations in the design of existing clinical trials with pregnant persons and the lack of a comparison group in the V-Safe Registry point to the urgent need for additional vaccine safety and efficacy data by trimester of vaccine exposure and encompassing both short and longer term outcomes for pregnant people and their offspring relative to an unexposed comparison group. With administrative supplement funding to parent award 1P50HD106463-01 and using the established U.S. MotherToBaby pregnancy cohort study at UC San Diego, we propose to complete new enrollment and follow-up of 900 COVID-19 vaccine exposed individuals (all brands, all doses, all trimesters of exposure) and 900 unvaccinated comparators to evaluate pregnancy outcomes including major congenital malformations, spontaneous abortion, stillbirth, preterm delivery, small for gestational age infants, postnatal growth through one year of age. In addition, through one year post-partum we will compare the incidence of SARS-CoV-2 infection post-vaccination in maternal/child pairs who were vaccinated in pregnancy to the incidence of infection in gestational-age matched maternal/child pairs who were not vaccinated in pregnancy. Finally, in a subset of 180 vaccinated individuals (60 per trimester of exposure) representing exposure to one of the two mRNA vaccine products we will obtain blood samples following the last vaccination dose in pregnancy in order to examine immune response in pregnancy. These data will provide essential safety and efficacy information that can support COVID-19 vaccine-related public health recommendations in this special population.


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: 2025 ( Subtotal = -$2,554,130 )
2025	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	4	3/1/2025	NON-COMPETING CONTINUATION	$0
2025	2022	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	001	1	5/13/2025	SUPPLEMENT FOR EXPANSION	-$2,554,130
														Subtotal = -$2,554,130

Issue Date FY: 2024 ( Subtotal = $8,161,207 )
2024	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	4	7/24/2024	NON-COMPETING CONTINUATION	$1,231,207
2024	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	001	3	7/25/2024	SUPPLEMENT FOR EXPANSION	$3,465,000
2024	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	002	4	7/26/2024	SUPPLEMENT FOR EXPANSION	$3,465,000
														Subtotal = $8,161,207

Issue Date FY: 2023 ( Subtotal = $1,239,102 )
2023	2023	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DRIVE	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	3	8/15/2023	NON-COMPETING CONTINUATION	$1,239,102
														Subtotal = $1,239,102

Issue Date FY: 2022 ( Subtotal = $5,335,377 )
2022	2022	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	002	2	8/9/2022	NON-COMPETING CONTINUATION	$1,250,000
2022	2022	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	001	1	6/10/2022	SUPPLEMENT FOR EXPANSION	$3,069,641
2022	2022	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	003	2	8/15/2022	SUPPLEMENT FOR EXPANSION	$1,015,736
2022	2021	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	1	2/17/2022	NEW	$0
														Subtotal = $5,335,377

Issue Date FY: 2021 ( Subtotal = $1,250,000 )
2021	2021	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	1	9/10/2021	NEW	$1,250,000
														Subtotal = $1,250,000

Grand Total All Awards = $13,431,556

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Optimization of Antibiotics in Mothers and their Breastfed Infants Using Pharmacomicrobiomic and Metabolomic Analyses

Award Number: P50HD106463

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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