With the SARS-CoV-2 pandemic underway, researchers at the University of California San Diego School of Medicine, in collaboration with the American Academy of Allergy Asthma and Immunology (AAAAI), will continue a nationwide study to assess the safety of COVID-19 vaccines in pregnancy and monitor the immune response of mother and baby after vaccinations.
Published research has found that pregnant women are particularly vulnerable to SARS-CoV-2 infection and are at higher risk of developing a more severe or complicated course of the disease, including an increased risk of death from about 70%. 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 vaccination against COVID-19. However, only about a third of pregnant women chose vaccination,” said Christina Chambers, PhD, MPH, principal investigator of the Vaccines and Medications Monitoring System in Pregnancy (VAMPSS). coordinated by AAAAI, Professor in the Department of Pediatrics at UC San Diego School of Medicine and Director of the Organization of Teratology Information Specialists (OTIS) MotherToBaby Pregnancy Studies.
“As pregnant people were not included in the original clinical trials for COVID-19 vaccines, it is essential to do this work to help provide concrete information about the safety and benefits of these vaccines for the mother and the baby. baby.”
The continuation of the study efforts is made possible by a four-year, $10 million grant and involves evaluating the safety of COVID-19 vaccinations among 1,800 participants.
Using the US MotherToBaby Pregnancy Cohort Study established at UC San Diego, researchers will follow 900 people who received one or more doses of any COVID-19 vaccine during pregnancy and 900 who did not. They will assess pregnancy outcomes, including major birth defects, miscarriages, stillbirths, premature deliveries, and postpartum growth of infants up to one year of age.
In a subset of 180 women participating in the study, researchers will also take blood samples after vaccination during different trimesters of pregnancy to measure the cellular immune response to SARS-CoV-2.
Researchers will study the expansion of T cells that recognize spike and non-spike regions of the virus. The development of T-cell memory, essential for determining long-lasting protection against infection, will also be defined with the measurement of anti-SARS-CoV-2 antibodies in mother and baby after delivery.
The results of this substudy will provide critical efficacy information that can support public health recommendations related to the COVID-19 vaccine in this particular population.”
Alessandra Franco, MD, PhD, study co-investigator, immunologist, and associate professor in the Department of Pediatrics at UC San Diego School of Medicine
“We are confident that this study will provide important information in support of best clinical practices for obstetrics providers and their patients,” said Michael Schatz, MD, lead coordinator of the AAAAI study.
The study will continue to recruit pregnant people through 2024, with final results expected in 2026.
Those interested in participating can contact MotherToBaby Pregnancy Studies at mothertobaby.org/pregnancy-studies or by calling 877-311-8972.