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Principal Investigator: CHRISTINA CHAMBERS
Organization: UNIVERSITY OF CALIFORNIA, SAN DIEGO
Fiscal Year: 2022
Award: $3,069,641
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
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.
Terms: <0-11 years old><1 year of age><1 year old><2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV vaccine><21+ years old><Active Follow-up><Administrative Supplement><Adult><Adult Human><Antibiotic Agents><Antibiotic Drugs><Antibiotics><Award><Birth Defects><Blood Sample><Blood specimen><Breast fed infant><Breastfed infant><COVID-19 antibody><COVID-19 infection><COVID-19 vaccine><COVID-19 virus><COVID19 infection><COVID19 vaccine><COVID19 virus><Child><Child Youth><Children (0-21)><Chronologic Fetal Maturity><Clinical Trials><CoV-2><CoV2><Cohort Studies><Concurrent Studies><Congenital Abnormality><Congenital Anatomic Abnormality><Congenital Anatomical Abnormality><Congenital Defects><Congenital Deformity><Congenital Malformation><Consent><Data><Disease><Disorder><Dose><Enrollment><Exposure to><Fetal Age><Funding><Generalized Growth><Gestation><Gestational Age><Growth><Growth and Development><Growth and Development function><Immune response><Immunological response><Incidence><Individual><Infant><Infection><Maternal Mortality><Menses><Menstruation><Miscarriage><Miscellaneous Antibiotic><Mothers><Outcome><Parents><Persons><Population><Postpartum><Postpartum Period><Pregnancy><Pregnancy Outcome><Premature Birth><Prematurely delivering><Preterm Birth><Public Health><RNA vaccine><RNA-based vaccine><Recommendation><Registries><Risk><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV-2 antibody><SARS-CoV-2 infection><SARS-CoV-2 vaccine><SARS-CoV2><SARS-CoV2 antibody><SARS-CoV2 infection><SARS-CoV2 vaccine><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 vaccine><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Safety><Sampling><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome coronavirus 2 vaccine><Severe acute respiratory syndrome related corona virus 2><Small for Gestational Age Infant><Special Population><Spontaneous abortion><Tissue Growth><Vaccinated><Vaccination><Vaccinee><Vaccines><Wuhan coronavirus><active followup><adulthood><adverse pregnancy outcome><age 1 year><aged 1 year><aged one year><antibody against COVID-19><antibody against SARS-CoV-2><antibody against SARS-CoV2><antibody against coronavirus disease 2019><antibody against severe acute respiratory syndrome coronavirus 2><antibody to COVID-19><antibody to SARS-CoV-2><antibody to SARS-CoV2><antibody to coronavirus disease 2019><antibody to severe acute respiratory syndrome coronavirus 2><breast feeding infant><breastfeeding infant><comparator group><comparison group><corona virus disease 2019 vaccine><coronavirus disease 2019 antibody><coronavirus disease 2019 infection><coronavirus disease 2019 vaccine><coronavirus disease 2019 virus><coronavirus disease-19 vaccine><coronavirus disease-19 virus><death risk><design><designing><enroll><follow up><follow-up><followed up><followup><hCoV19><host response><immune system response><immunoresponse><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with severe acute respiratory syndrome coronavirus 2><mRNA vaccine><mRNA-based vaccine><maternal death><maternal risk><menstrual period><metabolism measurement><metabolomics><metabonomics><monthly period><mortality risk><nCoV2><non vaccinated><not vaccinated><offspring><one year of age><one year old><ontogeny><post-partum><postnatal><pregnant><premature childbirth><premature delivery><preterm delivery><severe acute respiratory syndrome coronavirus 2 antibody><small for gestational age><stillbirth><stillborn><unvaccinated><vaccinated individual><vaccinated participant><vaccinated patient><vaccinated person><vaccinated subject><vaccine against 2019-nCov><vaccine against SARS-CoV-2><vaccine against SARS-CoV2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine efficacy><vaccine for novel coronavirus><vaccine safety><youngster>