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Studies

CMV Studies

CMV research is relatively new in comparison with other diseases and illnesses with Dr. Hugo Ribbert first observing CMV cells in the kidneys of a stillborn baby back in 1881. Over the next 20 years, similar cells were found in the salivary glands of children who had died of various causes. In 1960, CMV was successfully isolated in the urine of infants with an active infection and Dr. Thomas Weller officially coined the term "cytomegalovirus”. In these last 55 years, definite strides have been made in the field of CMV research, including the development and administration of antiviral treatments and vaccine candidates. Read up on a few recent studies that are advancing the field of CMV research and check out the National Institutes of Health’s PubMed website to learn more.
 

Active Studies

A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)

The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies, with Cytogam - a Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV), will reduce the number of babies infected with CMV. The research study is funded by the Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD) and 14 medical centers across the country are actively recruiting participants. 

Hearing Loss Treatment Study

The Collaborative Anti-Viral Study Group (CASG) at the University of Alabama Birmingham, Department of Pediatrics has an ongoing treatment study. Your child may qualify for this study if:
  • He/she is one month through three years of age (before the child's fourth birthday)
  • He/she has a recent (in the previous 12 weeks) diagnosis of hearing loss
For more information about this study, please contact Jill Griffin (jgriffin@peds.uab.edu) or Leslie Black (lblack@peds.uab.edu), or by phone 205-996-2424. CASG can provide additional information and/or connect you with a site or contact in your area.

Randomized Controlled Trial of Valganciclovir for Asymptomatic Cytomegalovirus Infected Hearing Impaired Infants (ValEAR Trial)

National Institute on Deafness and Other Communication Disorders (NIDCD).

The primary goal of this NIH funded multi-institutional study, spearheaded by principal investigator Dr. Albert Park, will be to determine whether CMV–infected hearing impaired only infants, treated with the antiviral drug valganciclovir, will have better hearing and language outcomes compared to untreated CMV-infected hearing impaired infants. Currently, the standard of care is to not treat these infants with valganciclovir since there was no previous efficacy and safety clinical trial data. We will also evaluate the safety of this drug, evaluate drug levels, viral levels and resistance in all enrollees.
 
Please direct questions to 801-213-4055.

Safety, Tolerability, and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to 35 Years of Age

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

Does Hygiene Counseling Have an Impact on the Rate of CMV Primary Infection During Pregnancy?  

A French study sought to determine the efficacy of CMV education counseling for pregnant women. The three-year CMV study tested pregnant women for CMV towards the end of their first trimester then followed with prevention education to those women who had never been exposed to CMV. Results found that fewer women went on to acquire CMV during pregnancy after adopting the recommended prevention measures.

Saliva Polymerase-Chain-Reaction Assay for Cytomegalovirus Screening in Newborns

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.

Valganciclovir for Symptomatic Congenital Cytomegalovirus Disease

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.
 
I tell every pregnant woman I know to get tested. I was so blindsided and had never heard about CMV. I sometimes think back to what I could have done differently. I don't know if there is something. I know God gave us Liam for a reason. I look at his smiling face everyday and find nothing but joy.
— Polly, Mother