@article{9d74c2d050f843ff82637b630791adcd,
title = "Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol",
abstract = "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.",
keywords = "COVID-19 vaccines, Immunogenicity, Infant immune responses, Postpartum women, Pregnant women",
author = "Munoz, {Flor M.} and Beigi, {Richard H.} and Posavad, {Christine M.} and Richardson, {Barbra A.} and Chu, {Helen Y.} and Karin Bok and James Campbell and Cristina Cardemil and Emily DeFranco and Frenck, {Robert W.} and Mamodikoe Makhene and Piper, {Jeanna M.} and Jeanne Sheffield and Ashley Miller and Neuzil, {Kathleen M.}",
note = "Funding Information: F.M.M. is an investigator of pediatric studies of COVID-19 vaccines for Pfizer and Moderna, and for a pediatric remdesivir study conducted by Gilead Sciences, Inc.; serves as investigator on projects supported by an NIH contract for a Vaccine Treatment and Evaluation Unit (VTEU), serves as member of the Data Safety monitoring Board (DSMB) for clinical trials conducted by Pfizer, Moderna, Meissa Vaccines, Virometix, and the NIH; and is a member of the American Academy of Pediatrics Committee of Infectious Diseases (COID_, the Immunization Expert Group of the American College of Obstetrics and Gynecology (ACOG), and Co-Chair of the COVAX Maternal Immunization Working Group. Funding Information: K.M.N. is a member of the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization, serves as co-investigator on an NIH contract for a Vaccine Treatment and Evaluation Unit (VTEU), serves as Co-chair of the NIH COVID Prevention Network (CoVPN), and served as an investigator for Phase I/II Pfizer COVID-19 vaccine grant, with a grant to the institution, but no salary support. Funding Information: This work is supported by the IDCRC through the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, under award number UM1AI148684. This protocol went through the review process associated with these networks, including IDCRC and NIH review. The sponsor contact is Jordan A. Kindbom, Jordan.kindbom@nih.gov. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. NIAID participated in protocol design. Publisher Copyright: {\textcopyright} 2022, The Author(s).",
year = "2022",
month = dec,
doi = "10.1186/s12884-022-04500-w",
language = "English (US)",
volume = "22",
journal = "BMC Pregnancy and Childbirth",
issn = "1471-2393",
publisher = "BioMed Central",
number = "1",
}