COVID-19MOMI-VaxNCT05031468

Multisite Observational Maternal and Infant Study for COVID-19

An observational study of COVID-19, run by Emory University at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is an observational, non-interventional, prospective cohort study designed to collect clinical information and specimens to evaluate the immune responses from pregnant individuals and postpartum individuals and their infants following maternal receipt of licensed or Emergency Use Authorization (EUA) severe acute… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Licensed or EUA SARS-CoV-2 vaccine
Type of treatment: Vaccines
How many people: 562 participants
Where: 10 sitesUnited States
Study dates: 6 Jul 2021to 16 Aug 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Pregnant individuals and postpartum individuals (within 2 months of delivery) who will be or have been vaccinated with a licensed or EUA SARS-CoV-2 vaccine, and their infants will be enrolled. Individuals receiving additional SARS-CoV-2 vaccine (beyond the primary series) during pregnancy will also be enrolled. Upon delivery, the infants born to individuals who received vaccine during pregnancy will become study participants.

Who may be able to join

Pregnant individuals who are scheduled to receive or have received complete vaccination series of any licensed or EUA SARS-CoV-2 vaccine during pregnancy. (NOTE: no limitation health status, or gestational age at enrollment)
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).
Inclusion Criteria for Additional Dose(s) During Pregnancy Group (Group 5):
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.

Show all 10Show fewer

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.

Who cannot join

Behavioral (including a history of alcohol or drug abuse within 1 year prior to study enrollment) or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Emory University
Atlanta, Georgia, 30322
University of Illinois at Chicago
Chicago, Illinois, 60607
University of Cincinnati
Cincinnati, Ohio, 45221
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Baylor College of Medicine
Houston, Texas, 77030
New York University Langone Vaccine Center
New York, New York, 10016
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center (UPMC) Magee - Womens Hospital
Pittsburgh, Pennsylvania, 15213
University of Rochester
Rochester, New York, 14642
Seattle Children's Hospital
Seattle, Washington, 98105

Other trials in United States

About this study

Official title: 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

Read the detailed description

SARS-CoV-2, the novel coronavirus that causes Coronavirus Disease 2019 (COVID-19) disease, first emerged in Wuhan, China in December 2019 and has continued to spread globally. SARS-CoV-2 is highly transmissible between humans. A number of public health measures, including social distancing, avoidance of large congregations, particularly indoors, and the wearing of face masks, have been introduced to prevent spread of the virus. However, once these measures are relaxed, unless population immunity exceeds herd immunity thresholds, recrudescence of SARS-CoV-2 is expected. This underscores the urgent need for a safe and effective SARS-CoV-2 vaccine.

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: COVID-19
Being tested: Licensed or EUA SARS-CoV-2 vaccine
Keywords: Immunization, Pregnancy, Lactation
Medical subject headings: COVID-19, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Licensed or EUA SARS-CoV-2 vaccineBiological
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.

Study groups in NCT05031468
Study group	Role	What they receive
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) Receives: Biological: Licensed or EUA SARS-CoV-2 vaccine
Group 2: Individuals vaccinated postpartum		Individuals who receive a SARS-CoV-2 vaccine postpartum (up to 65 individuals per vaccine type) Receives: Biological: Licensed or EUA SARS-CoV-2 vaccine
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) Receives: Biological: Licensed or EUA SARS-CoV-2 vaccine
Group 4: Infants of individuals vaccinated postpartum		Infants of individuals who receive a SARS-CoV-2 vaccine postpartum (approximately 65 infants per vaccine type) Receives: Biological: Licensed or EUA SARS-CoV-2 vaccine
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). Receives: Biological: Licensed or EUA SARS-CoV-2 vaccine
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). Receives: Biological: Licensed or EUA SARS-CoV-2 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Among Individuals Vaccinated During Pregnancy
The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine during pregnancy will be assessed as the GMT of IgG enzyme-linked immunosorbent assay (ELISA), by vaccine type and/or platform (mRNA, viral vector, etc.).
Measured: Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12
Change in GMT of Neutralizing (Neut) Antibodies in Serum Among Individuals Vaccinated During Pregnancy
The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine during pregnancy will be assessed as the GMT of Neut antibodies by vaccine type, platform and dose regimen.
Measured: Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12
GMT of Cord Blood IgG
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of IgG in cord blood, overall and by vaccine type, platform and dose regimen.
Measured: At delivery
Ratio of Cord Blood IgG to Maternal Serum IgG
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood IgG to maternal serum IgG, overall and by vaccine type, platform and dose regimen.
Measured: At delivery
Neut antibodies of cord blood
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of Neut antibodies in cord blood, overall and by vaccine type, platform and dose regimen.
Measured: At delivery
Ratio of cord blood Neut antibodies to maternal serum Neut antibodies
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood Neut antibodies to maternal Neut antibodies, overall and by vaccine type and platform.
Measured: At delivery
Change GMT of serum IgG in Infants Born to Individuals Vaccinated During Pregnancy
The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated during pregnancy will be assessed as the GMT of IgG in infants, by vaccine type, platform and dose regimen.
Measured: At delivery, 2 months of age, 6 months of age
Change GMT of Neut antibodies in Infants Born to Individuals Vaccinated During Pregnancy
The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated during pregnancy will be assessed as the GMT of Neut antibodies in infants, by vaccine type, platform and dose regimen.
Measured: At delivery, 2 months of age, 6 months of age

Secondary outcomes (25)

Frequency of Maternal Outcomes
The frequency of maternal outcomes among individuals receiving the SARS-CoV-2 vaccine during pregnancy or postpartum will be compared to background rates in the United States, overall and by vaccine type and platform.
Measured: At delivery
Frequency of Infant Outcomes
The frequency of infant outcomes among infants born to individuals receiving the SARS-CoV-2 vaccine during pregnancy or postpartum will be compared to background rates in the United States, overall and by vaccine type and platform.
Measured: At delivery
GMT of Serum IgG Compared to Non-Pregnant Women
GMT of Serum IgG in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be compared to non-pregnant populations of women of childbearing age.
Measured: 28 days post-vaccination
GMT of Neut Antibodies Compared to Non-Pregnant Women
GMT of Neut antibodies in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be compared to non-pregnant populations of women of childbearing age.
Measured: 28 days post-vaccination
GMT of Serum IgG by Gestational Age at Vaccination
GMT of serum IgG in individuals receiving different SARS-CoV-2 vaccines during pregnancy will be examined by gestational age at vaccination (trimester of gestation) and interval between vaccination and delivery, by vaccine type and platform.
Measured: 28 days post-vaccination
GMT of Neut Antibodies by Gestational Age at Vaccination
GMT of Neut antibodies in individuals receiving different SARS-CoV-2 vaccines during pregnancy will be examined by gestational age at vaccination (trimester of gestation) and interval between vaccination and delivery, by vaccine type and platform.
Measured: 28 days post-vaccination
GMT of Serum IgG by Baseline Characteristics
GMT of serum IgG in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be examined by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.
Measured: 28 days post-vaccination
GMT of Neut Antibodies by Baseline Characteristics
GMT of Neut antibodies in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be examined by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.
Measured: 28 days post-vaccination
GMT of Cord Blood IgG by Gestational Age at Vaccination
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of IgG in cord blood, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform.
Measured: At delivery
Ratio of Cord Blood IgG to Maternal Serum IgG by Gestational Age at Vaccination
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood IgG to maternal serum IgG, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform.
Measured: At delivery
GMT of Cord Blood Neut Antibodies by Gestational Age at Vaccination
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT Neut antibodies in cord blood, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform.
Measured: At delivery
Ratio of Cord Blood Neut Antibodies to Maternal Serum Neut Antibodies by Gestational Age at Vaccination
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood Neut antibodies to maternal Neut antibodies, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform.
Measured: At delivery
GMT of Cord Blood IgG by Baseline Characteristics
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of IgG in cord blood, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.
Measured: At delivery
Ratio of Cord Blood IgG to Maternal Serum IgG by Baseline Characteristics
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood IgG to maternal serum IgG, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.
Measured: At delivery
GMT of Cord Blood Neut Antibodies by Baseline Characteristics
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT Neut antibodies in cord blood, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.
Measured: At delivery
Ratio of Cord Blood Neut Antibodies to Maternal Serum Neut Antibodies by Baseline Characteristics
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood Neut antibodies to maternal Neut antibodies, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform.
Measured: At delivery
Change in GMT of IgG in Breast Milk
The kinetics of SARS-CoV-2 antibodies in breast milk of mothers who received vaccine during pregnancy or postpartum, will be assessed as the GMT of IgG in breast milk, overall and by vaccine type and platform.
Measured: 2 weeks postpartum, and 2, 6, and 12 months postpartum
Change in GMT of Immunoglobulin A (IgA) in Breast Milk
The kinetics of SARS-CoV-2 antibodies in breast milk of mothers who received vaccine during pregnancy or postpartum, will be assessed as the GMT of IgA in breast milk, overall and by vaccine type and platform.
Measured: 2 weeks postpartum, and 2, 6, and 12 months postpartum
Change in GMT of Neut Antibodies in Breast Milk
The kinetics of SARS-CoV-2 antibodies in breast milk of mothers who received vaccine during pregnancy or postpartum, will be assessed as the GMT of Neut Antibodies in breast milk, overall and by vaccine type and platform.
Measured: 2 weeks postpartum, and 2, 6, and 12 months postpartum
Change in GMT of Serum IgG Among Individuals Vaccinated Postpartum
The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine postpartum will be assessed as the GMT of IgG, by vaccine type and/or platform.
Measured: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12
Change in GMT of Neutralizing (Neut) Antibodies in Serum Among Individuals Vaccinated Postpartum
The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine postpartum will be assessed as the GMT of Neut antibodies, by vaccine type and/or platform.
Measured: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12
Change GMT of serum IgG in Infants Born to Individuals Vaccinated Postpartum
The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated postpartum will be assessed as the GMT of IgG in infants, by vaccine type and platform.
Measured: 2 months of age, 6 months of age
Change GMT of Neut antibodies in Infants Born to Individuals Vaccinated Postpartum
The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated postpartum will be assessed as the GMT of Neut antibodies in infants, by vaccine type and platform.
Measured: 2 months of age, 6 months of age
Change in GMT of Serum IgG Among Individuals Receiving Additional Vaccine Dose(s)
The kinetics and durability of maternal serum antibodies following receipt of additional dose(s) of SARS-CoV-2 vaccine in pregnant individuals who received vaccine prior to pregnancy, will be assessed as the GMT of IgG in serum, by vaccine type and platform.
Measured: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12
Change in GMT of Neut Antibodies Among Individuals Receiving Additional Vaccine Dose(s)
The kinetics and durability of maternal serum antibodies following receipt of additional dose(s) of SARS-CoV-2 vaccine in pregnant individuals who received vaccine prior to pregnancy, will be assessed as the GMT of Neut antibodies, by vaccine type and platform.
Measured: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 202116 Aug 2023

First posted2 Sep 2021
Study start6 Jul 2021
Primary completion16 Aug 2023
Study completion16 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 562 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05031468
Sponsor's protocol ID: STUDY00002767
Other IDs: 3UM1AI148576-02S5
Acronym: MOMI-Vax
Status last verified: Jun 2024
First submitted: 26 Aug 2021
Last updated: 27 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data will be made available for sharing for secondary research, following de-identification.

Publications

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.
PubMed 35550037
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.
PubMed 35734087
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.
PubMed 38332733

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05031468
Acronym / sponsor ID: MOMI-Vax / STUDY00002767
Conditions: COVID-19
Keywords: Immunization, Pregnancy, Lactation
Study type: Observational
Recruitment status: Completed
Enrolment: 562 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 6 Jul 2021 (actual)
Primary completion: 16 Aug 2023 (actual)
Study completion: 16 Aug 2023 (actual)
First posted: 2 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 6

Arm	Type	Receives
Group 1: Individuals vaccinated during pregnancy	–	Biological: Licensed or EUA SARS-CoV-2 vaccineIndividuals who receive a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccine during pregnancy (up to 200 individuals per vaccine type)
Group 2: Individuals vaccinated postpartum	–	Biological: Licensed or EUA SARS-CoV-2 vaccineIndividuals who receive a SARS-CoV-2 vaccine postpartum (up to 65 individuals per vaccine type)
Group 3: Infants of individuals vaccinated during pregnancy	–	Biological: Licensed or EUA SARS-CoV-2 vaccineInfants of individuals who receive a SARS-CoV-2 vaccine during pregnancy (approximately 200 infants per vaccine type)
Group 4: Infants of individuals vaccinated postpartum	–	Biological: Licensed or EUA SARS-CoV-2 vaccineInfants of individuals who receive a SARS-CoV-2 vaccine postpartum (approximately 65 infants per vaccine type)
Group 5: Individuals receiving additional vaccines during pregnancy	–	Biological: Licensed or EUA SARS-CoV-2 vaccineIndividuals who receive additional SARS-CoV-2 vaccine(s), beyond the primary series, during pregnancy (up to 200 individuals).
Group 6: Infants of individuals receiving additional vaccines during pregnancy	–	Biological: Licensed or EUA SARS-CoV-2 vaccineInfants of individuals who received additional SARS-CoV-2 vaccine(s), beyond the primary series, during pregnancy (approximately 200 infants).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Pregnant individuals and postpartum individuals (within 2 months of delivery) who will be or have been vaccinated with a licensed or EUA SARS-CoV-2 vaccine, and their infants will be enrolled. Individuals receiving additional SARS-CoV-2 vaccine (beyond the primary series) during pregnancy will also be enrolled. Upon delivery, the infants born to individuals who received vaccine during pregnancy will become study participants.

Key inclusion criteria (10 listed)

Pregnant individuals who are scheduled to receive or have received complete vaccination series of any licensed or EUA SARS-CoV-2 vaccine during pregnancy. (NOTE: no limitation health status, or gestational age at enrollment)
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.

Key exclusion criteria (2 listed)

Behavioral (including a history of alcohol or drug abuse within 1 year prior to study enrollment) or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Licensed or EUA SARS-CoV-2 vaccineSeveral 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.	Biological	Group 1: Individuals vaccinated during pregnancy, Group 2: Individuals vaccinated postpartum, Group 3: Infants of individuals vaccinated during pregnancy, Group 4: Infants of individuals vaccinated postpartum, Group 5: Individuals receiving additional vaccines during pregnancy, Group 6: Infants of individuals receiving additional vaccines during pregnancy

Primary outcome

Change in Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Among Individuals Vaccinated During Pregnancy
Time frame: Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12
The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine during pregnancy will be assessed as the GMT of IgG enzyme-linked immunosorbent assay (ELISA), by vaccine type and/or platform (mRNA, viral vector, etc.).
Change in GMT of Neutralizing (Neut) Antibodies in Serum Among Individuals Vaccinated During Pregnancy
Time frame: Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12
The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine during pregnancy will be assessed as the GMT of Neut antibodies by vaccine type, platform and dose regimen.
GMT of Cord Blood IgG
Time frame: At delivery
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of IgG in cord blood, overall and by vaccine type, platform and dose regimen.
Ratio of Cord Blood IgG to Maternal Serum IgG
Time frame: At delivery
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood IgG to maternal serum IgG, overall and by vaccine type, platform and dose regimen.
Neut antibodies of cord blood
Time frame: At delivery
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of Neut antibodies in cord blood, overall and by vaccine type, platform and dose regimen.
Ratio of cord blood Neut antibodies to maternal serum Neut antibodies
Time frame: At delivery
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood Neut antibodies to maternal Neut antibodies, overall and by vaccine type and platform.
Change GMT of serum IgG in Infants Born to Individuals Vaccinated During Pregnancy
Time frame: At delivery, 2 months of age, 6 months of age
The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated during pregnancy will be assessed as the GMT of IgG in infants, by vaccine type, platform and dose regimen.
Change GMT of Neut antibodies in Infants Born to Individuals Vaccinated During Pregnancy
Time frame: At delivery, 2 months of age, 6 months of age
The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated during pregnancy will be assessed as the GMT of Neut antibodies in infants, by vaccine type, platform and dose regimen.

25 secondary outcomes

Frequency of Maternal Outcomes
Time frame: At delivery
Frequency of Infant Outcomes
Time frame: At delivery
GMT of Serum IgG Compared to Non-Pregnant Women
Time frame: 28 days post-vaccination
GMT of Neut Antibodies Compared to Non-Pregnant Women
Time frame: 28 days post-vaccination
GMT of Serum IgG by Gestational Age at Vaccination
Time frame: 28 days post-vaccination
GMT of Neut Antibodies by Gestational Age at Vaccination
Time frame: 28 days post-vaccination
GMT of Serum IgG by Baseline Characteristics
Time frame: 28 days post-vaccination
GMT of Neut Antibodies by Baseline Characteristics
Time frame: 28 days post-vaccination
GMT of Cord Blood IgG by Gestational Age at Vaccination
Time frame: At delivery
Ratio of Cord Blood IgG to Maternal Serum IgG by Gestational Age at Vaccination
Time frame: At delivery
GMT of Cord Blood Neut Antibodies by Gestational Age at Vaccination
Time frame: At delivery
Ratio of Cord Blood Neut Antibodies to Maternal Serum Neut Antibodies by Gestational Age at Vaccination
Time frame: At delivery
GMT of Cord Blood IgG by Baseline Characteristics
Time frame: At delivery
Ratio of Cord Blood IgG to Maternal Serum IgG by Baseline Characteristics
Time frame: At delivery
GMT of Cord Blood Neut Antibodies by Baseline Characteristics
Time frame: At delivery
Ratio of Cord Blood Neut Antibodies to Maternal Serum Neut Antibodies by Baseline Characteristics
Time frame: At delivery
Change in GMT of IgG in Breast Milk
Time frame: 2 weeks postpartum, and 2, 6, and 12 months postpartum
Change in GMT of Immunoglobulin A (IgA) in Breast Milk
Time frame: 2 weeks postpartum, and 2, 6, and 12 months postpartum
Change in GMT of Neut Antibodies in Breast Milk
Time frame: 2 weeks postpartum, and 2, 6, and 12 months postpartum
Change in GMT of Serum IgG Among Individuals Vaccinated Postpartum
Time frame: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12
Change in GMT of Neutralizing (Neut) Antibodies in Serum Among Individuals Vaccinated Postpartum
Time frame: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12
Change GMT of serum IgG in Infants Born to Individuals Vaccinated Postpartum
Time frame: 2 months of age, 6 months of age
Change GMT of Neut antibodies in Infants Born to Individuals Vaccinated Postpartum
Time frame: 2 months of age, 6 months of age
Change in GMT of Serum IgG Among Individuals Receiving Additional Vaccine Dose(s)
Time frame: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12
Change in GMT of Neut Antibodies Among Individuals Receiving Additional Vaccine Dose(s)
Time frame: Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
Background: PubMed 35550037Munoz 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.
Results publication: PubMed 35734087Munoz 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.
Results publication: PubMed 38332733Cardemil 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.
Individual participant dataSharing planned: Yes. Individual participant data will be made available for sharing for secondary research, following de-identification.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Flor Munoz, MD principal investigator

Baylor College of Medicine

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Emory University at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Among Individuals Vaccinated During Pregnancy (time frame: Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05031468, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.