Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol

Flor M. Munoz; Richard H. Beigi; Christine M. Posavad; Barbra A. Richardson; Helen Y. Chu; Karin Bok; James Campbell; Cristina Cardemil; Emily DeFranco; Robert W. Frenck; Mamodikoe Makhene; Jeanna M. Piper; Jeanne Sheffield; Ashley Miller; Kathleen M. Neuzil

doi:10.1186/s12884-022-04500-w

Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol

Flor M. Munoz
, Richard H. Beigi
, Christine M. Posavad
, Barbra A. Richardson
, Helen Y. Chu
, Karin Bok
, James Campbell
, Cristina Cardemil
, Emily DeFranco
, Robert W. Frenck
, Mamodikoe Makhene
, Jeanna M. Piper
, Jeanne Sheffield
, Ashley Miller
, Kathleen M. Neuzil

Obstetrics and Gynecology

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

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.

Original language	English
Article number	402
Journal	BMC Pregnancy and Childbirth
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s12884-022-04500-w
State	Published - Dec 2022

Bibliographical note

Publisher Copyright:
© 2022, The Author(s).

Funding

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. 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, [email protected]. 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.

Funders	Funder number
American Academy of Pediatrics Committee
COVAX Maternal Immunization Working Group
IDCRC
Immunization Expert Group of the American College of Obstetrics and Gynecology
Vaccine Treatment and Evaluation Unit
National Institutes of Health (NIH)	UM1AI148684
National Institute of Allergy and Infectious F32-AI286447 Cydney N. Johnson Diseases National Institute of Allergy and Infectious R01AI168214 Jason W. Rosch Diseases National Institute of Allergy and Infectious P30 Cydney N. Johnson Diseases National Institute of Allergy and Infectious R00-AI166116 Christopher D. Radka Diseases National Institute of Allergy and Infectious T32-AI106700 Cydney N. Johnson Diseases National Institute of Allergy and Infectious R01AI192221 Jason W. Rosch Diseases National Inst...	UM1AI148689
World Health Organization
American Congress of Obstetricians and Gynecologists

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

COVID-19 vaccines
Immunogenicity
Infant immune responses
Postpartum women
Pregnant women

ASJC Scopus subject areas

Obstetrics and Gynecology

Access to Document

10.1186/s12884-022-04500-w

Cite this

Munoz, F. M., Beigi, R. H., Posavad, C. M., Richardson, B. A., Chu, H. Y., Bok, K., Campbell, J., Cardemil, C., DeFranco, E., Frenck, R. W., Makhene, M., Piper, J. M., Sheffield, J., Miller, A., & Neuzil, K. M. (2022). Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol. BMC Pregnancy and Childbirth, 22(1), Article 402. https://doi.org/10.1186/s12884-022-04500-w

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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 = "Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = dec,

doi = "10.1186/s12884-022-04500-w",

language = "English",

volume = "22",

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Munoz, FM, Beigi, RH, Posavad, CM, Richardson, BA, Chu, HY, Bok, K, Campbell, J, Cardemil, C, DeFranco, E, Frenck, RW, Makhene, M, Piper, JM, Sheffield, J, Miller, A & Neuzil, KM 2022, 'Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol', BMC Pregnancy and Childbirth, vol. 22, no. 1, 402. https://doi.org/10.1186/s12884-022-04500-w

TY - JOUR

T1 - Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax)

T2 - a study protocol

AU - Munoz, Flor M.

AU - Beigi, Richard H.

AU - Posavad, Christine M.

AU - Richardson, Barbra A.

AU - Chu, Helen Y.

AU - Bok, Karin

AU - Campbell, James

AU - Cardemil, Cristina

AU - DeFranco, Emily

AU - Frenck, Robert W.

AU - Makhene, Mamodikoe

AU - Piper, Jeanna M.

AU - Sheffield, Jeanne

AU - Miller, Ashley

AU - Neuzil, Kathleen M.

PY - 2022/12

Y1 - 2022/12

N2 - 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.

AB - 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.

KW - COVID-19 vaccines

KW - Immunogenicity

KW - Infant immune responses

KW - Postpartum women

KW - Pregnant women

UR - https://www.scopus.com/pages/publications/85129944732

UR - https://www.scopus.com/pages/publications/85129944732#tab=citedBy

U2 - 10.1186/s12884-022-04500-w

DO - 10.1186/s12884-022-04500-w

M3 - Article

C2 - 35550037

AN - SCOPUS:85129944732

VL - 22

JO - BMC Pregnancy and Childbirth

JF - BMC Pregnancy and Childbirth

IS - 1

M1 - 402

ER -

Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol

Abstract

Bibliographical note

Funding

UN SDGs

Keywords

ASJC Scopus subject areas

Access to Document

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Cite this