IDCRC studies COVID-19 vaccines during pregnancy and postpartum, the MOMI-Vax Study
Infectious Diseases Clinical Research Consortium (IDCRC) researchers at sites across the country are conducting a clinical study of immune responses to various COVID-19 vaccines when administered to people during or just after pregnancy.
The observational, non-interventional study will evaluate the safety and immune responses created by various COVID-19 vaccines when administered to pregnant or postpartum individuals. These vaccines were granted emergency use authorization from the U.S. Food and Drug Administration and provide protection against the SARS-CoV-2 virus in adults. The study will also assess how vaccine-induced antibodies transfer to infants through breast milk and the placenta.
“We have a unique opportunity to learn more about maternal immunity after vaccination and the potential for protecting newborns and young infants from COVID-19 through maternal immunization. This is particularly important given that COVID-19 vaccines are not yet available for infants,” says Flor Munoz, MD, MSc, associate professor, pediatric infectious diseases, Baylor College of Medicine and protocol co-chair and lead site principal investigator.
The study is being conducted by the IDCRC in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Visit ClinicalTrials.gov and search identifier NCT05031468 for additional details.
Unique to this study, pregnant participants can enroll during their first trimester of pregnancy and will be followed for up to 12-months after delivery. The study duration for infants and postpartum individuals is 12-months post delivery. This study will enroll approximately 750 pregnant individuals and 250 postpartum individuals who have received or will receive an authorized SARS-CoV-2 vaccine and their infants in the United States. Vaccines will not be provided through this study.
“At the current state of the coronavirus pandemic response, this study design represents an optimal approach to learn from the thousands of pregnant and post-partum women who have already opted and continue to choose to take vaccines to protect against COVID-19,” says Richard H. Beigi, MD, MSc, professor, reproductive sciences, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh and protocol co-chair.
Participating IDCRC sites:
The observational, non-interventional study will evaluate the safety and immune responses created by various COVID-19 vaccines when administered to pregnant or postpartum individuals. These vaccines were granted emergency use authorization from the U.S. Food and Drug Administration and provide protection against the SARS-CoV-2 virus in adults. The study will also assess how vaccine-induced antibodies transfer to infants through breast milk and the placenta.
“We have a unique opportunity to learn more about maternal immunity after vaccination and the potential for protecting newborns and young infants from COVID-19 through maternal immunization. This is particularly important given that COVID-19 vaccines are not yet available for infants,” says Flor Munoz, MD, MSc, associate professor, pediatric infectious diseases, Baylor College of Medicine and protocol co-chair and lead site principal investigator.
The study is being conducted by the IDCRC in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Visit ClinicalTrials.gov and search identifier NCT05031468 for additional details.
Unique to this study, pregnant participants can enroll during their first trimester of pregnancy and will be followed for up to 12-months after delivery. The study duration for infants and postpartum individuals is 12-months post delivery. This study will enroll approximately 750 pregnant individuals and 250 postpartum individuals who have received or will receive an authorized SARS-CoV-2 vaccine and their infants in the United States. Vaccines will not be provided through this study.
“At the current state of the coronavirus pandemic response, this study design represents an optimal approach to learn from the thousands of pregnant and post-partum women who have already opted and continue to choose to take vaccines to protect against COVID-19,” says Richard H. Beigi, MD, MSc, professor, reproductive sciences, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh and protocol co-chair.
Participating IDCRC sites:
- Baylor College of Medicine Vaccine and Treatment Evaluation Unit (VTEU)
- University of Rochester VTEU
- New York University VTEU
- Emory University VTEU
- Cincinnati Children’s Hospital Medical Center VTEU
- UPMC Magee Women’s Hospital, subsite of University of Maryland VTEU
- Children’s Hospital of Philadelphia, subsite of Vanderbilt VTEU
- Seattle Children’s Hospital, subsite of University of Washington VTEU
- University of Illinois at Chicago, subsite of Saint Louis University VTEU