Evidence map›Paper›PMID 35550037›Full record

ArticleBMC pregnancy and childbirth2022

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 and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pregnancy and childbirth, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05031468 (Observational, Prospective Cohort Study of the Immunogenicity and Safety of SARS-CoV-2 Vaccines Administered During Pregnancy or Postpartum and Evaluation of Antibody Transfer and Durability in Infants), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05031468 completednot on this map

Observational, Prospective Cohort Study of the Immunogenicity and Safety of SARS-CoV-2 Vaccines Administered During Pregnancy or Postpartum and Evaluation of Antibody Transfer and Durability in Infants

TypeobservationalSponsorEmory UniversityRan2021 to 2023Enrolled562ConditionsCOVID-19ArmsLicensed or EUA SARS-CoV-2 vaccine
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  2. Article
  3. Article
  4. Article
  5. An Update on COVID-19 Vaccination and Pregnancy.Journal of personalized medicine · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 1 country.

Flor M MunozDepartments of Pediatrics and Molecular Virology and Microbiology, Section of Infectious Diseases, Baylor College of Medicine, 1102 Bates St. Suite 1150, Houston, TX, 77030, USA. florm@bcm.edu.ORCID http://orcid.org/0000-0001-8598-6347
Richard H BeigiDepartment of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh School of Medicine, UPMC Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA, 15213, USA.
Christine M PosavadVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, and Department of Laboratory Medicine and Pathology, University of Washington, 1100 Fairview Ave N, Seattle, WA, 98109, USA.
Barbra A RichardsonDepartment of Biostatistics, University of Washington, and Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, 98109, USA.
Helen Y ChuDepartment of Epidemiology, University of Washington School of Public Health, 750 Republican St, Seattle, WA, 98109, USA.
Karin BokOffice of Director, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, Bethesda, MD, 20892, USA.
James CampbellCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, 685 W. Baltimore St, Baltimore, MD, 21201, USA.
Cristina CardemilDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Rockville, MD, 20892, USA.
Emily DeFrancoDepartment of Obstetrics and Gynecology, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267-0526, USA.
Robert W FrenckDepartment of Pediatrics, University of Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, MLC 6014, Cincinnati, OH, 45229, USA.
Mamodikoe MakheneDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Rockville, MD, 20892, USA.
Jeanna M PiperDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Rm 8B68, MSC 9831, Rockville, MD, 20892, USA.
Jeanne SheffieldDepartment of Gynecology and Obstetrics, Johns Hopkins University, 600 N Wolfe St., Nelson Building 2nd floor, Baltimore, MD, 21287, USA.
Ashley MillerFHI 360, 359 Blackwell Street, Suite 200, Durham, NC, 27701, USA.
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, 685 W. Baltimore St, Baltimore, MD, 21201, USA.
National Institutes of Health · USUniversity of Washington · USUniversity of Maryland, Baltimore · USBaylor College of Medicine · USCincinnati Children's Hospital Medical Center · USFamily Health International 360 · USJohns Hopkins University · USSabin Vaccine Institute · USUniversity of Pittsburgh · US

Funding

Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG) - Momi-Vax DMID #21-0004 {Supplement #6}UM1AI148684 · NIAID · EMORY UNIVERSITY · PI DAVID S STEPHENS · 2020 to 2026
$77.2M
VTEU SupplementUM1AI148689 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI Karen L. Kotloff · 2020 to 2026
$52.7M
Vaccine and Treatment Evaluation Units (VTEU)-DMID 21-0004UM1AI148575 · NIAID · BAYLOR COLLEGE OF MEDICINE · PI HANA M EL SAHLY · 2020 to 2026
$29.4M
Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required) - Moderna Pediatric StudyUM1AI148372 · NIAID · CINCINNATI CHILDRENS HOSP MED CTR · PI Robert Wilson Frenck · 2020 to 2026
$20.5M
NIAID NIH HHS UM1 AI148372NIAID NIH HHS UM1 AI148575NIAID NIH HHS UM1 AI148684NIAID NIH HHS UM1 AI148689
6 · The paper itself

Abstract

backgroundPregnant 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.

methodsThe 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 registrationNCT05031468 .

Indexed as

COVID-19COVID-19 VaccinesFemaleHumansInfantInfant, NewbornLactationMulticenter Studies as TopicObservational Studies as TopicPregnancyProspective StudiesCOVID-19 VaccinesCOVID-19 vaccinesImmunogenicityInfant immune responsesPostpartum womenPregnant women

Identifiers

PMID35550037
PMCPMC9096328
OpenAlexW4280545608

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.