Austin Regional Clinic testing vaccine for common cause of birth defects

By the time you're 40, you probably have had the cytomegalovirus and not even known it. It's a virus similar to chicken pox because it lives inside you once you've had it.

Cytomegalovirus — commonly known as CMV — causes typical virus symptoms like fever, sore throat or fatigue in most people. It can be detrimental for a pregnant person who gets it and passes it to their fetus. It can cause birth defects or even death for that fetus.

Now vaccine company Moderna is testing a new mRNA vaccine to prevent CMV infections in women of child-bearing age. Austin Regional Clinic's clinical research arm has three locations doing the national trials of this vaccine.

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CMV is the most common infection a person can pass on to their babies during pregnancy. In the United States, 1 in 200 babies are born with CMV and 20% of those  will have birth defects or long-term health problems. These include hearing loss, vision loss, developmental and motor delays, seizures and a smaller than typical head.

"t can be really severe," said Dr. Sharon Vaz, an obstetrician with Austin Regional Clinic.

Mothers aren't tested for CMV because there's nothing that can be done to help the fetus once she gets sick. In babies, it's picked up on an ultrasound when the technician finds a smaller head or fluid around the heart. At birth, a rash or jaundice, an enlarged spleen or liver and or small size of the baby might also indicate CMV, Vaz said.

It also matters at what point in the pregnancy a baby got the infection, she said. Babies infected in the first trimesters tend to have the most birth defects or health problems, but babies can become infected at any stage of pregnancy and even during birth.

These birth defects are not reversible.

This vaccine study was actually supposed to happen at the beginning of the pandemic, but got delayed as Moderna needed to focus on its COVID-19 vaccine development and trials.

The CMV vaccine trials are looking for women ages 16 to 40 who are not currently pregnant and do not plan to get pregnant in the next nine months. They have to be in good health and not have more than a 35 body mass index. Because CMV is a common infection for young children with more than a third of people having been infected by age 5, participants 20 and older have to have regular contact with a child 5 and younger at least eight hours a week.

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During the trial three injections are given over the course of six months. Half of the people will receive the vaccine and half will receive a placebo. . Researchers will follow their  health and antibodies to CMV for 30 months.

The researchers are looking to see if people who have never had CMV and receive the vaccine develop good antibodies against it and if people who have had CMV but get the vaccine develop better antibodies against CMV.  In CMV, reinfection is possible and if that happens during pregnancy, that can be detrimental to the baby.

Participants will receive monetary compensation for their time.

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Dr. Gretchen Crook, who is leading the trial at one of the ARC clinical research locations, said while this trial won't be as easy to recruit participants as the COVID-19 trials, she's hoping people who have known children with CMV-caused abnormalities will sign up as well as people who are interested in contributing to science or lessening birth defects.

The hope is that just like pregnant women get a flu shot, a TDaP (tetanus, diphtheria and pertussis) vaccine, and now a COVID-19 vaccine during pregnancy to protect their babies, a CMV vaccine also will be added during early pregnancy or even before.

To find out more about the trial, call ARC Clnical Research at 512-225-5931 or go to Moderna's CMVictory.com site.

This article originally appeared on Austin American-Statesman: Austin Regional Clinic testing vaccine for CMV virus