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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol
BMC Pregnancy and Childbirth, Volume 22, No. 1, Article 402, Year 2022
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Description
Background: Pregnant women were excluded from investigational trials of COVID-19 vaccines. Limited data are available to inform pregnant and postpartum women on their decisions to receive a COVID-19 vaccine. Methods: The goal of this observational, prospective cohort study is to evaluate the immunogenicity and safety of various Emergency Use Authorization (EUA) or licensed COVID-19 vaccines administered to pregnant or lactating women and describe the transplacental antibody transfer and kinetics of antibodies in mothers and infants. The study is adaptive, allowing additional groups to be added as new vaccines or vaccine regimens are authorized. Up to 20 clinical research institutions in the United States (U.S.) will be included. Approximately 200 pregnant women and 65 postpartum women will be enrolled per EUA or licensed COVID-19 vaccine formulation in the U.S. This study will include pregnant and postpartum women of all ages with and without chronic medical conditions. Their infants will be enrolled and followed beginning at birth in the pregnant cohort and beginning at the earliest possible time point in the postpartum cohort. Blood samples will be collected for immunogenicity outcomes and pregnancy and birth outcomes assessed among women and infants. Primary analyses will be descriptive and done by vaccine type and/or platform. Discussion: Given the long-standing and legitimate challenges of enrolling pregnant individuals into clinical trials early in the vaccine development pipeline, this study protocol describes our current study and provides a template to inform the collection of data for pregnant individuals receiving COVID-19 or other vaccines. Trial registration: NCT05031468. © 2022, The Author(s).
Authors & Co-Authors
Muňoz, Flor M.
United States, Houston
Baylor College of Medicine
Beigi, Richard H.
United States, Pittsburgh
University of Pittsburgh School of Medicine
Posavad, Christine M.
United States, Seattle
Fred Hutchinson Cancer Center
Richardson, Barbra Ann
United States, Seattle
Fred Hutchinson Cancer Center
Chu, Helen Y.
United States, Seattle
University of Washington
Bok, Karin
United States, Bethesda
National Institutes of Health Nih
Campbell, James D.
United States, Baltimore
University of Maryland School of Medicine
Cardemil, Cristina V.
United States, Bethesda
National Institutes of Health Nih
DeFranco, Emily A.
United States, Cincinnati
University of Cincinnati College of Medicine
Frenck, Robert W.
United States, Cincinnati
Cincinnati Children's Hospital Medical Center
Makhene, Mamodikoe K.
United States, Bethesda
National Institutes of Health Nih
Piper, Jeanna M.
United States, Bethesda
National Institutes of Health Nih
Sheffield, Jeanne S.
United States, Baltimore
Johns Hopkins University
Neuzil, Kathleen Maletic
United States, Baltimore
University of Maryland School of Medicine
Statistics
Citations: 2
Authors: 14
Affiliations: 10
Identifiers
Doi:
10.1186/s12884-022-04500-w
ISSN:
14712393
Research Areas
Covid
Maternal And Child Health
Sexual And Reproductive Health
Study Design
Cross Sectional Study
Cohort Study
Study Approach
Quantitative
Participants Gender
Female