Emory University is participating in a study evaluating immune responses to COVID-19 vaccines, when the vaccines are administered during pregnancy or within two months after delivery.
The study, called SARS-CoV-2 Vaccines in Pregnancy and Postpartum or MOMI-Vax, is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. MOMI-Vax is being conducted by the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC).
MOMI-Vax is open to people who have received any of the FDA-authorized COVID-19 vaccines. The early COVID-19 vaccine clinical trials generally excluded pregnant women, so there is limited data on immune responses for this special population. However, after the FDA authorized the vaccines, regulators gave people who were pregnant or soon to be pregnant the option of choosing to get the vaccines. Tens of thousands of pregnant and breastfeeding people across the country have been vaccinated — and this is the group researchers who are part of MOMI-Vax are seeking to reach.
At Emory, investigators at the Hope Clinic of Emory Vaccine Center, Emory University Midtown, Emory University Hospital, Emory Children’s Center and Grady Memorial Hospital are taking part.
“This is both a necessary and important study in pregnant and postpartum women, because it is critical that we better understand both the maternal immune response to COVID-19 vaccinations in pregnancy and antibody transfer to babies via the placenta and breast milk,” says Emory principal investigator Martina Badell, MD, who is associate professor of gynecology and obstetrics, in the Division of Maternal-Fetal Medicine at Emory University School of Medicine. “Additionally, this large study will allow us to systematically study the safety of these vaccines in the special population of pregnant patients and their infants. “
Emory’s VTEU (Vaccine Treatment and Evaluation Unit) is supporting the study. Emory’s VTEU is led by Nadine Rouphael, MD, Evan Anderson, MD, and Carlos del Rio, MD — representing the Hope Clinic of Emory Vaccine Center, Emory Children’s Center and Grady Memorial Hospital, respectively.
Studies to gather safety data for COVID-19 vaccination during pregnancy and breastfeeding have already begun, and so far, COVID-19 vaccines appear to be safe in these populations. The NIAID study will build on these studies by improving researchers’ understanding of antibody responses to COVID-19 vaccines among pregnant and postpartum people and the transfer of antibodies to their infants.
Researchers will measure the development and durability of antibodies against SARS-CoV-2, the virus that causes COVID-19, in people vaccinated during pregnancy or the first two postpartum months. In addition, researchers will assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.
Experience with other diseases suggests that the transfer of vaccine-induced antibodies from mother to baby could help protect newborns and infants from COVID-19 during early life. Investigators want to assess the potential effects on maternal immune responses and transfer of antibodies across the placenta according to the mother’s age, the trimester of pregnancy during which the vaccine was received, the mother’s health and the mother’s COVID-19 risk status.
Nationwide, the MOMI-Vax investigators will enroll up to 750 pregnant individuals and 250 postpartum individuals within two months of delivery who have received or will receive any COVID-19 vaccine authorized or licensed by the U.S. Food and Drug Administration (currently: Moderna, Pfizer-BioNTech, and Johnson & Johnson; others may be authorized in the future). Their infants also will be enrolled in the study. Vaccines are not provided to participants as part of the study protocol.
Participants and their infants will be followed through the first year after delivery. Researchers will analyze blood samples collected from pregnant and postpartum participants at study enrollment, at delivery for participants who enrolled during pregnancy, and at two, six and 12 months after delivery.
Participants enrolled in the study prior to receiving the vaccine will have blood drawn at enrollment as well as approximately one month after vaccination. Researchers will also perform antibody testing on samples from umbilical cord blood collected at delivery and blood samples collected from infants two and six months after delivery.
Additionally, mothers will have the option of providing breast milk samples at approximately two weeks, two months, six months and 12 months after delivery. The investigators will evaluate breast milk antibodies to assess the potential for protection against COVID-19 in breastfed infants. Study staff also will gather information on COVID-19 illnesses in pregnant and postpartum participants, birth and neonatal outcomes and COVID-19 illnesses in infant participants.
Those interested in participating in the trial at the Hope Clinic, located in Decatur, can fill out a volunteer form or contact the Hope Clinic. The Emory Children’s Center vaccine research site’s preferred contact mode is via email: ecc.vaccine@emory.edu.
About Infectious Disease Clinical Research Consortium (IDCRC)
The IDCRC, consisting of the VTEUs and the IDCRC Leadership Group, was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, other affiliated sites and NIAID.