A large national clinical trial to evaluate the Pfizer-BioNTech COVID-19 vaccine for safety and efficacy in pregnant women is now open for enrollment at The University of Texas Health Science Center at Houston (UTHealth).
“Pregnant women who are infected with COVID-19 are five times more likely to have severe illness, be admitted to a hospital, or have preterm delivery. But because we have limited data from pregnant women who are not on placebo-controlled trials or have self-reported after vaccination, the best way to learn of efficacy, differences in side effects, or possible impact on fetal development is through a randomized, double-blinded, placebo-controlled trial,” said Houston site lead investigator Sandra Hurtado, MD, an assistant professor of OB-GYN with McGovern Medical School at UTHealth.
For the Phase II/III study, researchers across the country are enrolling 4,000 healthy women over the age of 18 who are between 27 and 34 weeks pregnant. The trial is randomized and placebo-controlled and sites are allowed to recruit competitively until all slots are filled. It is also investigator-blinded, so that only the nurse who gives the shot, who is not part of the research team, knows whether the patient received the vaccine or placebo. The Houston site is in the UTHealth Women’s Research Program – Memorial City.
“UTHealth Houston is a very diverse community at the forefront of clinical and biological research, so it’s important for us to participate in trials that can make a difference for our nation and world,” Hurtado said. “With our diversity in ethnicities and culture, we can integrate a different population base in the trial.”
Women who are part of the UTHealth site trial will be required to deliver their baby at Memorial Hermann Memorial City so that the researchers can collect and test the cord blood to see if antibodies that may have developed in the mother have transferred to the child. After delivery, women will be told whether or not they received the vaccine and any who were in the placebo arm will be able to receive it. Patients who received the vaccine and their infants will be followed for six months after delivery.
“Women who participate understand that they may or may not get the drug, but they have an interest in being able to advance medicine and science,” Hurtado said.
Joining Hurtado, who is in the Department of Obstetrics, Gynecology and Reproductive Services, on the study are Ebony Beaudoin, MD, associate professor in the Department of Pediatrics at McGovern Medical School; Lori Wink, NP, with UT Physicians Women’s Center-Bellaire and UT Physicians Women’s Center II-Memorial City; and Joanne Veloz Jacinto, RN, study coordinator with the UTHealth Women’s Research Program – Memorial City. UT Physicians is the clinical practice of McGovern Medical School.
For more information about the trial, call 713-486-6640 or visit the website.
For media inquiries, call 713-500-3030