Congenital CMV Studies
Active Studies
Help advance our understanding of how the experiences of caring for a child with cCMV impacts families by completing up to 3 online questionnaires. This research study is open to caregivers, children with cCMV, and siblings. This paid research study is sponsored by RTI and Moderna. Learn more here.
The CMVictory Trial is studying mRNA-1647, an investigational vaccine, to understand whether it can help the immune system protect against CMV. The purpose of this clinical trial is to evaluate the safety and efficacy of mRNA-1647 investigational vaccine against CMV and evaluate the safety of the mRNA-1647 investigational vaccine in women who test positive to prior exposure to CMV. The study is conducted by Moderna.
For more info: https://trials.modernatx.com/study/?id=mRNA-1647-P301
With the goal of improving infant outcomes by creating disease specific guidance, interventions and support systems , the CUBS study is studying the developmental trajectories of infants with cCMV , their relationship with maternal stress, wellbeing and parenting experiences. Parents will complete PediaTrac, as well as the Little Ears surveys at five timepoints the first year of an infant ’ s life. The surveys track parent reported development and milestone achievement s . Remote participation enables the inclusion of parents across the US and Canada. Dr. Megan Pesch is the principal investigator on this NIH funded study.
Please contact Megan Thompson at cmvbabiesstudy@umich.edu for more information.
CMV Mothers’Beliefs, Experiences,And Relationships Study – Mama Bear Study
Researchers at the University of Michigan would like to learn more abou t the experience of bi ological mother s whose children have been diagnosed with cCMV. Mothers with children between ages 3 and 15 will complete a short survey prior to a zoom interview with a representative from ISR . The s emi - structure d interviews will discuss the experience with the diagnostic process and opportunities for intervention and treatment after the diagnosis of cCMV . Funding from the Congenital and Perinatal Infections Consortium (CPIC) makes this remote ly administered study possible.
More information is available at https://UMHealthResearch.org/studies/HUM00259824 or email cmvmamabearstudy@umich.edu
This is a Phase I study to determine the dose of oral letermovir to administer to neonates. Once we know this, we will develop a combination therapy study assessing the clinical benefit of oral valganciclovir + letermovir on clinically relevant disease outcomes such as hearing and development.
A Clinical Trial of a CMV Vaccine for Kids and Teens Ages 9-15 Years Old
Part 1 of the trial has completed enrollment and was determining which dose level of the trial vaccine, mRNA-1647, has the best safety profile in association with the production of the best amount of protective antibodies against CMV in kids and teens ages 9 – 15. Part 2 of the trial is currently enrolling participants. Part 2 is being conducted to expand the number of children who will receive the dose of the vaccine selected in Part 1. There will also be a placebo group, to compare the safety and immune response of the investigational vaccine against CMV, mRNA-1647, which is being studied to potentially prevent CMV infection in kids and teens ages 9 – 15 years old.For more info: https://trials.modernatx.com/study/?id=mRNA-1647-P104
Merck Sharp & Dohme Corp, is actively recruiting and enrolling healthy, seronegative women ages 16-35 in multiple cities and locations to participate in this phase 2 vaccine study! The primary hypothesis of the study is that administration of a 3-dose regimen (day 1, month 2, and month 6) of V160 will reduce the incidence of primary CMV infection compared to placebo. Please direct questions to your local clinic or healthcare provider for more information.
Past Studies
The primary goal of this NIH funded multi-institutional study, spearheaded by principal investigator Dr. Albert Park, was to be to determine whether CMV–infected infants with hearing loss only, treated with the antiviral drug valganciclovir, would have better hearing and language outcomes compared to untreated CMV-infected infants with hearing loss only. This trial ended due to recruitment difficulties without definitive answers to the main study question.
The purpose of this research study was to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies, with Cytogam - a Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV), would reduce the number of babies infected with cCMV. From 2012-2018, 712 participants were enrolled in the study and 399 underwent randomization. The trial was stopped early for futility, meaning that there was not a statistically significant benefit in rates of CMV transmission to the fetus in groups who received the immunoglobulin vs those who did not. One participant in the hyperimmuno globulin group had a severe allergic reaction. Participants who received hyperimmune globilin had higher rates of headaches and shaking chills. The study concluded that among pregnant women, administration of CMV hyperimmmune globulin did not result in lower incidence of congenital CMV infection or perinatal death than placebo.
A University of Alabama at Birmingham study found that an inexpensive polymerase chain-reaction (PCR)-based saliva swab test could help identify newborns with congenital CMV, who are at risk for developing hearing loss during childhood. Researchers report that this PCR test, costing only $2.50 to $3 per test, showed high sensitivity and specificity, identifying infected newborns with greater than 97 percent accuracy.
This randomized, placebo-controlled trial of valganciclovir found that extending treatment of infants born symptomatic with congenital CMV from the traditional six weeks to six months helped to improve hearing and developmental outcomes. The CMV study end points included change in hearing in the better ear (“best-ear” hearing) from baseline to 6 months as well as change in hearing from baseline to follow-up at 12 and 24 months.
Asymptomatic Congenital CMV Treatment
Infants with congenital CMV without baseline hearing loss were recruited from participating sites between August 2019 and September 2020. Enrolled infants were treated with valganciclovir. Infants had their hearing tested at ages 4 and 6 months. Although 7 participants were originally enrolled, only two had hearing related data at 6 months. Some infants had adverse effects from taking the medication, although none with seriour adverse events. The trial was stopped early due to low enrollment.
Valganciclovir Treatment for Congenital CMV in Older Infants and Children
This study sought to evaluate whether antiviral therapy might effective in improving hearing outcomes in older infants and children with congenital CMV. Older infants and children with congenital CMV (ages 1 month to 3 years) with sensorineural hearing loss were given either valganciclovir or placebo treatment for 6 weeks. 16 and 15 children were enrolled in each group. In the placebo group, hearing either improced or did not change in 27/28 ears analyzed (hearing worsened in one ear for one child). However, in the intervention group hearing stayed stable or improved in 20/26 ears but worsened in six ears. Three children in the placebo group and no children in the active medication group experienced adverse events.
