CHRI to lead COVID-19 vaccine trials in pregnant women, children

Physician-scientists in Omaha will be on the leading edge of research to ensure a safe, effective COVID-19 vaccine for pregnant women and children. The Child Health Research Institute (CHRI), a pediatric research partnership between UNMC and Children’s Hospital & Medical Center, will be leading two new COVID-19 vaccine trials in these unique, important populations. Both studies are sponsored by Pfizer.

The first trial is a randomized, placebo-controlled study evaluating the safety, tolerability and effectiveness of a vaccine candidate against COVID-19 in pregnant women and their newborns. Kari Simonsen, MD, chair of the UNMC Department of Pediatrics and pediatrician-in-chief at Children’s, will serve as the site primary investigator; Teresa Berg, MD, associate professor of obstetrics and gynecology at UNMC and director of maternal-fetal medicine, will be the lead co-investigator.

Participants will be patients from the Olson Center for Women’s Health who intend to deliver their baby at Nebraska Medicine. The global study aims to recruit 4,000 pregnant women; it is anticipated around 50 women will be enrolled from the Omaha site. The vaccinated mothers and their babies will be followed until the baby is 6 months old. After a child’s birth, maternal participants who received the placebo will be unblinded and able to receive the vaccine.

The second trial is a pediatric study, evaluating a vaccine’s safety and efficacy in healthy children ages 5 to 18. Dr. Simonsen will serve as site primary investigator. CHRI will partner closely with Children’s Physicians primary care offices to recruit study participants starting in late spring or early summer; however, children not cared for at these locations may also be enrolled. This global study will involve around 6,000 pediatric participants. The Omaha site plans to enroll around 50 children. Vaccine administration will take place at Children’s Specialty Pediatric Center, led by Children’s Pediatric Infectious Disease specialists.

“COVID-19 vaccine studies for pregnant women and children build on the knowledge gained from the completed adult studies. These important trials provide necessary safety and effectiveness information to expand implementation of COVID-19 vaccines to these groups. We are proud to contribute to these global efforts,” Dr. Simonsen said.

“CHRI is excited to support these two vaccine studies conducted by our highly skilled investigators at our sponsoring institutions, Children’s and UNMC. Bringing world-class research to the children of Omaha and Nebraska is core to our mission, and we are proud to be a part of ensuring that children have safe and effective access to a COVID-19 vaccine in a timely manner,” said Ann Anderson Berry, MD, PhD, executive director of CHRI and professor in the UNMC Department of Pediatrics.

CHRI’s mission is to improve the health of children through innovative research, collaborative discovery, community engagement and advocacy. Learn more here.