With the SARS-CoV-2 pandemic ongoing, researchers at 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 vaccinations during pregnancy, and monitor immune response for mother and baby following vaccinations.
Published research has found that pregnant people are particularly vulnerable to SARS-CoV-2 infection and at higher risk of developing a more serious or complicated disease course, including approximately a 70 percent increased risk of death. Infection in pregnancy also increases the risk for preterm delivery and other adverse pregnancy outcomes, including stillbirth.
“Pregnant people are considered a priority population for COVID-19 vaccination. However, only about a third of pregnant persons have chosen vaccination,” said Christina Chambers, PhD, MPH, principal investigator on 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 the Organization of Teratology Information Specialists (OTIS) MotherToBaby Pregnancy Studies.
“As pregnant persons were not included in the original clinical trials for COVID-19 vaccinations, there is a critical need to do this work to help provide concrete information about the safety and benefits of these vaccines for both mother and baby.”
The continuation of study efforts is made possible by a $10 million, four-year grant and involves evaluating the safety of COVID-19 vaccinations among 1,800 participants.
The investigators will study the expansion of T lymphocytes that recognize spike and non-spike regions of the virus. The development of T cell memory, critical to determine long-lasting protection from infection, will be also defined together with the measurement of anti-SARS-CoV-2 antibodies in both mother and baby after delivery.
“The results of this sub-study will provide essential efficacy information that can support COVID-19 vaccine-related public health recommendations in this special population,” said Alessandra Franco, MD, PhD, co-investigator on the study, immunologist and associate professor in Department of Pediatrics at UC San Diego School of Medicine.
The study will continue enrolling pregnant persons through 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 calling 877-311-8972.
This story was originally published by the University of California, San Diego on June 23, 2022.