In light of the ongoing SARS-CoV-2 pandemic, researchers from the University of California San Diego School of Medicine in collaboration with the American Academy of Allergy Asthma and Immunology (AAAAI) will continue a national study to evaluate the safety of COVID-19 vaccines during of pregnancy and monitoring of the immune response of mother and child after vaccination.
Published research has found that pregnant women are particularly vulnerable to SARS-CoV-2 infection and are at greater risk of developing a more serious or complicated course of the disease, including an approximately 70 percent increased risk of death. Infection during pregnancy also increases the risk of preterm birth and other adverse pregnancy outcomes, including stillbirth.
“Pregnant women are considered a priority population for COVID-19 vaccination. However, only about one-third of pregnant women chose to vaccinate,” said Christina Chambers, PhD, MPH, principal investigator for the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS), coordinated by AAAAI, professor in the Department of Pediatrics at UC San Diego School of Medicine and Director of MotherToBaby Pregnancy Studies for the Organization of Teratology Information Specialists (OTIS).
“Because pregnant individuals were not included in the original clinical trials for COVID-19 vaccines, there is an urgent need to conduct this work to help provide concrete information on the safety and benefits of these vaccines for mother and child.”
The continued study effort is made possible by a four-year, $10 million grant and includes evaluating the safety of COVID-19 vaccines among 1,800 participants.
Using the well-established US pregnancy cohort study MotherToBaby at UC San Diego, the researchers will track 900 people who received one or more doses of a COVID-19 vaccine during pregnancy and 900 who did not. They will assess pregnancy outcomes, including major birth defects, miscarriages, stillbirths, preterm births, and postpartum growth of infants up to one year of age.
For a subset of 180 women in the study, researchers will also collect post-vaccination blood samples at different trimesters of pregnancy to measure cellular immune responses to SARS-CoV-2.
Researchers will study the expansion of T lymphocytes that recognize spike and non-spike regions of the virus. The development of T-cell memory, which is crucial for determining long-lasting protection against infection, will also be defined along with the measurement of anti-SARS-CoV-2 antibodies in both mother and child after birth.
“The results of this substudy will provide essential efficacy information that can support public health recommendations related to COVID-19 in terms of public health,” said Alessandra Franco, MD, PhD, co-investigator of the study, immunologist and associate professor in the Department of Pediatrics at the UC San Diego School of Medicine.
“We are confident that this study will provide important information to support best clinical practice for obstetricians and their patients,” said Michael Schatz, MD, AAAAI senior study coordinator.
Pregnant women will be included in the study by 2024, with final results expected in 2026.
The study is supported in part by the National Institutes of Health (NIH) – Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD) MPRINT Hub and the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA). . Grant number 3P50 HD106463-01S1.
Individuals interested in participating can contact MotherToBaby Pregnancy Studies at mothertobaby.org/pregnancy-studies or by phone at 877-311-8972.