Multisite Observational Maternal and Infant Study for COVID-19
NCT ID: NCT05031468
Last Updated: 2024-06-27
Study Results
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Basic Information
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COMPLETED
562 participants
OBSERVATIONAL
2021-07-06
2023-08-16
Brief Summary
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Detailed Description
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While all vaccines in late-stage development are based on the SARS-CoV- 2 S glycoprotein, they differ in other important characteristics, including manufacturing platform, number of doses, and immunogenicity and safety profiles. Two messenger RNA (mRNA)-based vaccines BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (NIAID-Moderna) were granted Emergency Use Authorization (EUA) by the U.S. FDA based on high demonstrated efficacy against symptomatic infection and severe disease in diverse populations. Janssen (Johnson \& Johnson) was also granted EUA for their single dose nonreplicating adenovirus vector vaccine. None of these large vaccine trials enrolled pregnant or lactating women (except for a small number of lactating women who were enrolled in the Janssen study).
The mRNA vaccines are being distributed to prioritized population groups, and other vaccines are expected to follow as they receive EUA approval. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) gave a permissive recommendation for pregnant individuals who are in a priority group to receive SARS-CoV-2 vaccines based on risk of exposure or comorbidities. In addition, some states have included pregnant individuals in priority groups based on pregnancy itself being considered a high-risk condition by CDC. Thus, pregnant individuals are choosing to receive these vaccines under EUA, without trial data on safety and efficacy. There are neither data on the safety of SARS-CoV-2 vaccines in lactating women nor on the effects of mRNA or other vaccines on the breastfed infant or on milk production/excretion. Current EUA vaccines are not thought to be a risk to the breastfeeding infant.
Currently, additional doses of SARS-CoV-2 vaccines are being considered to enhance durability and breadth of protection, particularly against variant strains. On August 25, 2021, Pfizer submitted a supplement to their Biologics License Application (BLA) for their mRNA vaccine seeking approval for administration of an additional dose, and other manufacturers are expected to follow. In the setting of this rapidly evolving regulatory and policy environment, it is important that data on kinetics and durability of maternal and infant antibodies be generated for all vaccine regimens, including any additional doses beyond the primary series that may be administered to pregnant women.
Vaccines for pregnant individuals, such as influenza, tetanus and pertussis vaccines, are one of the most important public health measures globally to reduce disease in both mothers and infants in the first months of life. Various organizations support the position that pregnant and lactating women are a priority population and must not be excluded from the SARS-CoV-2 vaccine allocation strategy.
The purpose of this study is to evaluate the immunogenicity and safety of various licensed or EUA SARS-CoV-2 vaccines administered to pregnant or lactating women and describe the transplacental antibody transfer and kinetics of antibodies in infants. The researchers will also evaluate the durability of the antibodies in mothers and infants and assess breast milk antibodies in lactating women. The researchers will evaluate breast milk antibodies to assess potential for protection against COVID-19 in breastfed infants, similar to influenza vaccine protection from influenza illness in infants of mothers vaccinated during pregnancy or postpartum. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study. It is expected that the results of this study will inform policy recommendations and personal decision-making on the use of approved SARS-CoV-2 vaccines in pregnant and lactating individuals.
This is an observational, non-interventional, prospective cohort study designed to collect clinical information and specimens to evaluate the immune responses from approximately 2,000 study participants following maternal receipt of licensed or EUA SARS-CoV-2 vaccines. Participants receiving a SARS-CoV-2 vaccine either during pregnancy or within 2 months of delivery, and their infants, will be followed for 12 months after delivery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1: Individuals vaccinated during pregnancy
Individuals who receive a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccine during pregnancy (up to 200 individuals per vaccine type)
Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.
Group 2: Individuals vaccinated postpartum
Individuals who receive a SARS-CoV-2 vaccine postpartum (up to 65 individuals per vaccine type)
Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.
Group 3: Infants of individuals vaccinated during pregnancy
Infants of individuals who receive a SARS-CoV-2 vaccine during pregnancy (approximately 200 infants per vaccine type)
Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.
Group 4: Infants of individuals vaccinated postpartum
Infants of individuals who receive a SARS-CoV-2 vaccine postpartum (approximately 65 infants per vaccine type)
Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.
Group 5: Individuals receiving additional vaccines during pregnancy
Individuals who receive additional SARS-CoV-2 vaccine(s), beyond the primary series, during pregnancy (up to 200 individuals).
Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.
Group 6: Infants of individuals receiving additional vaccines during pregnancy
Infants of individuals who received additional SARS-CoV-2 vaccine(s), beyond the primary series, during pregnancy (approximately 200 infants).
Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.
Interventions
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Licensed or EUA SARS-CoV-2 vaccine
Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 3 vaccines, whether given as part of the primary series or additional doses, as part of this non-interventional study.
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures.
* Individuals who are scheduled to receive or who have initiated vaccination series of any licensed or EUA SARS-CoV-2 vaccine within the first 2 months postpartum. (NOTE: no limitation on health status).
* Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures (a separate consent form will be used for their infants).
* Pregnant individuals who received one dose or both doses of their primary vaccine series prior to pregnancy and are scheduled to receive or have received additional dose(s) of any licensed or EUA SARS-CoV-2 vaccine during pregnancy OR pregnant individuals who received complete vaccination series during pregnancy and are scheduled to receive or have received additional dose(s) of any licensed or EUA SARS-CoV-2 vaccine during pregnancy. (NOTE: no limitation on health status or gestational age at enrollment). This applies to individuals who have completed their primary series and receive an additional dose during pregnancy.
* Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures.
* ≥18 years of age at time of enrollment
* Understands and agrees to comply with all study procedures.
* Agrees to sign medical release for herself and her infant to allow study staff to gather pertinent medical information, pregnancy outcome data, and medical information as needed.
Exclusion Criteria
* Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
18 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Emory University
OTHER
Responsible Party
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Flor Munoz
Associate Professor
Principal Investigators
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Flor Munoz, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Emory University
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
New York University Langone Vaccine Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) Magee - Womens Hospital
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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References
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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. Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol. BMC Pregnancy Childbirth. 2022 May 12;22(1):402. doi: 10.1186/s12884-022-04500-w.
Munoz FM, Posavad CM, Richardson BA, Badell ML, Bunge K, Mulligan MJ, Parameswaran L, Kelly C, Olsen-Chen C, Novak RM, Brady RC, Pasetti M, DeFranco E, Gerber JS, Shriver M, Suthar MS, Moore K, Coler R, Berube B, Kim SH, Piper JM, Miller A, Cardemil C, Neuzil KM, Beigi R; DMID Study Group. COVID-19 booster vaccination during pregnancy enhances maternal binding and neutralizing antibody responses and transplacental antibody transfer to the newborn (DMID 21-0004). medRxiv [Preprint]. 2022 Jun 13:2022.06.13.22276354. doi: 10.1101/2022.06.13.22276354.
Cardemil CV, Cao Y, Posavad CM, Badell ML, Bunge K, Mulligan MJ, Parameswaran L, Olson-Chen C, Novak RM, Brady RC, DeFranco E, Gerber JS, Pasetti M, Shriver M, Coler R, Berube B, Suthar MS, Moreno A, Gao F, Richardson BA, Beigi R, Brown E, Neuzil KM, Munoz FM; MOMI-Vax Study Group. Maternal COVID-19 Vaccination and Prevention of Symptomatic Infection in Infants. Pediatrics. 2024 Mar 1;153(3):e2023064252. doi: 10.1542/peds.2023-064252.
Other Identifiers
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STUDY00002767
Identifier Type: -
Identifier Source: org_study_id
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