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 national study to assess the safety of COVID-19 vaccinations. during pregnancy and monitor the immune response of the mother and baby after vaccinations.
Published research has found that pregnant people are especially vulnerable to SARS-CoV-2 infection and have a higher risk of developing a more serious or complicated course of illness, including an approximately 70 percent increased risk of death. . Infection during pregnancy also increases the risk of premature 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 have chosen vaccination,” said Christina Chambers, PhD, MPH, lead researcher on the COVID-19. Pregnancy Vaccine and Medication Surveillance (VAMPSS) coordinated by AAAAI, professor in the Department of Pediatrics at UC San Diego School of Medicine and director of the Organization of Information Theratology Specialists (OTIS) MotherToBaby Pregnancy Studies.
“Because pregnant women were not included in the original clinical trials of COVID-19 vaccines, there is a critical need to do this work to help provide specific information about the safety and benefits of these vaccines both for to the mother as to the baby “.
Continuation of the study’s efforts is possible thanks to a four-year grant of $ 10 million and involves evaluating the safety of COVID-19 vaccinations among 1,800 participants.
Using the U.S.-based MotherToBaby pregnancy cohort study established at UC San Diego, researchers will track 900 people who received one or more doses of any COVID-19 vaccine during pregnancy and 900 who no. They will evaluate pregnancy outcomes such as significant birth defects, miscarriage, stillbirth, premature birth, and postpartum growth of babies up to one year of age.
In a subset of 180 women in the study, researchers will also collect blood samples after vaccination in different trimesters of pregnancy to measure the cellular immune response to SARS-CoV-2.
The researchers will study the expansion of T lymphocytes that recognize the ear and non-ear regions of the virus. The development of T-cell memory, critical for determining lasting protection from infection, will also be defined along 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 public health recommendations related to the COVID-19 vaccine in this special population. “
Alessandra Franco, MD, PhD, co-researcher 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 in support of best clinical practice for obstetric providers and their patients,” said Michael Schatz, MD, lead coordinator of the AAAAI study.
The study will continue to enroll pregnant people until 2024, with the 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.
Source:
University of California – San Diego