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.

Conflict of interest statement

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.

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.

B.R. currently holds a position on the Data and Safety Monitoring Board (DSMB) for clinical trials at Gilead Sciences, Inc.

All authors have completed relevant conflicts of interest in the Disclosure of Potential Conflicts of Interest section of the Authorship Form.

© 2022. The Author(s).

Figures

Fig. 1

Sample Size Calculation based on Width of 95% Confidence Intervals for Neutralizing Antibodies for COVID-19 Vaccines included in MOMI-Vax. Legend: The curve shows neutralizing antibody from Phase 1 studies and demonstrates the inflection point for sample size at approximately 150 individuals per group, with little gain in precision with higher samples sizes. Results similar using binding antibody data (results not shown)