Ongoing Clinical Trials for Cytomegalovirus Infection
There are currently 10 ongoing clinical trials investigating various approaches to preventing and treating cytomegalovirus (CMV) infection. These studies focus on different patient populations including transplant recipients, pregnant women, and healthy individuals, testing antiviral medications, cellular therapies, and vaccines across multiple European countries.
Clinical trial locations
- Belgium
- Study on Treating Resistant Viral Infections in Stem Cell Transplant Patients Using Allogeneic Multivirus-Specific T Cells
- Study on the Effectiveness and Safety of mRNA-1647 Vaccine for Preventing Cytomegalovirus in Healthy Individuals Aged 16 to 40
- Study on Valaciclovir to Prevent Congenital CMV Infection in Pregnant Women with First Trimester CMV Infections
- Estonia
- Finland
- France
- Study on Letermovir and Valganciclovir for Treating CMV Infections in Kidney Transplant Patients
- Study on Treating Resistant Viral Infections in Stem Cell Transplant Patients Using Allogeneic Multivirus-Specific T Cells
- Study on Prenatal Treatment of Congenital Cytomegalovirus Infection with Letermovir and Valaciclovir for Pregnant Women with CMV-Infected Fetuses
- Study on the Effectiveness and Safety of mRNA-1647 Vaccine for Preventing Cytomegalovirus in Healthy Individuals Aged 16 to 40
- Germany
- Italy
- Netherlands
- Poland
- Slovenia
- Spain
- Study on Letermovir for Preventing Cytomegalovirus in Stem Cell Transplant Patients with CMV-Positive Donors
- Study on Preventing Cytomegalovirus Infection in Stem Cell Transplant Patients Using Cytolytic T Lymphocytes
- Study on Ganciclovir and Valganciclovir for Preventing Cytomegalovirus in High-Risk Heart Surgery Patients
- Study on the Effectiveness and Safety of mRNA-1647 Vaccine for Preventing Cytomegalovirus in Healthy Individuals Aged 16 to 40
Study on Letermovir and Valganciclovir for Treating CMV Infections in Kidney Transplant Patients
This trial is investigating treatment options for patients who have received a kidney transplant and developed an infection. The study compares two approaches: combining letermovir with valganciclovir versus using valganciclovir alone.
Inclusion criteria: Participants must be at least 18 years old, weigh 30 kg or more, and have documented infection confirmed by two blood tests at least one day apart. They must have received a kidney transplant and be suitable for oral valganciclovir treatment. Women of childbearing age need a negative pregnancy test and must use effective contraception for 30 days after the study ends (90 days for men). Participants must speak French, have a life expectancy of at least 8 weeks, and be affiliated with a social security system.
Exclusion criteria: The study excludes patients who have had a kidney transplant or those with existing infections.
Study focus: The main goal is to determine whether combining letermovir with valganciclovir is more effective than valganciclovir alone in reducing viral levels by the third week of treatment. Researchers will monitor viral levels in blood, platelet counts in the fetus, and any side effects experienced by participants through regular blood tests and check-ups over a 12-week period.
Investigational drugs: Letermovir (available as PREVYMIS film-coated tablets) works by stopping the virus from multiplying. Valganciclovir is an antiviral medication that reduces the amount of virus in the body. Both drugs are taken orally.
Study on Treating Resistant Viral Infections in Stem Cell Transplant Patients Using Allogeneic Multivirus-Specific T Cells
This trial focuses on patients who have undergone allogeneic stem cell transplantation and are facing viral infections that do not respond to standard antiviral treatments. The viruses targeted are cytomegalovirus, Epstein-Barr virus, and adenovirus.
Inclusion criteria: Patients must be adults or children older than 2 months who have had a hematopoietic stem cell transplantation. They must have a new or reactivated infection with CMV, EBV, or AdV that has not improved after two weeks of standard antiviral treatment, as shown by blood tests. The original stem cell donor must be available and have an immune response to the virus. Written informed consent is required from the patient or their legal representative.
Exclusion criteria: The study excludes patients who have not undergone stem cell transplantation, do not have resistant viral infections, or whose viral infections respond to standard treatments. Children under 2 months and vulnerable populations are also excluded.
Study focus: The trial evaluates the effectiveness of specially designed immune cells called allogeneic multivirus-specific T cells in clearing resistant viral infections. These cells are delivered directly into the bloodstream through an intravenous infusion. Researchers monitor viral load, T-cell activity, and overall patient health through regular blood samples and check-ups from Day 0 to Week 15.
Investigational drugs: Multispecific T cells are designed to target and fight specific viruses. These specially engineered immune cells help the patient’s immune system better recognize and eliminate CMV, EBV, and AdV.
Study on Valacyclovir for Preventing and Treating Cytomegalovirus (CMV) in Pregnant Women
This study investigates the effectiveness and safety of valacyclovir in pregnant women who have a primary infection for the first time. The goal is to determine whether valacyclovir can prevent virus transmission from mother to baby and treat the infection, depending on the dose used.
Inclusion criteria: Participants must be pregnant women aged 18 years or older with evidence of seroconversion (new appearance of IgG antibodies during current pregnancy) or presence of IgM antibodies with low avidity IgG antibodies before 16 weeks of pregnancy. They must have a confirmed singleton pregnancy and provide written informed consent.
Exclusion criteria: Men and individuals who are not pregnant, unable to follow study procedures, taking interacting medications, allergic to the study medication, or previously treated for the same condition are excluded. Those currently enrolled in another clinical trial cannot participate.
Study focus: The trial monitors the presence of viral DNA in the amniotic fluid surrounding the baby, viral levels in maternal and fetal blood, and fetal platelet counts. Regular check-ups using ultrasound and blood tests track both mother and baby throughout pregnancy and after birth, with continued monitoring until the child reaches five years of age.
Investigational drugs: Valacyclovir is administered as film-coated tablets taken orally. The study compares different doses to understand which is most effective and safe for preventing and treating infection during pregnancy.
Study on Letermovir for Preventing Cytomegalovirus in Heart Transplant Patients
This trial explores the effectiveness of letermovir in preventing infection in individuals who have received a heart transplant. Heart transplant recipients with weakened immune systems are at increased risk of viral complications.
Inclusion criteria: Participants must be new heart transplant recipients aged 18 years or older with moderate or high risk serostatus (specific antibody levels related to the virus). They must have signed informed consent and cannot be enrolled in other interfering clinical trials.
Exclusion criteria: Patients who have not received a heart transplant, do not have an infection, are outside the specified age range, or belong to vulnerable populations are excluded.
Study focus: The study monitors the occurrence of early infections or disease during the treatment period, as well as rates of leukopenia (decreased white blood cells) and neutropenia (decreased neutrophils). Researchers also observe late infections occurring after medication is stopped and assess the body’s immune response over time. Monitoring continues for up to 6 months after stopping medication.
Investigational drugs: Letermovir (also known as MK-8228) is provided as PREVYMIS 240 mg film-coated tablets taken orally. It works by inhibiting viral replication, helping to protect patients from developing disease after transplantation.
Study on Letermovir for Preventing Cytomegalovirus in Stem Cell Transplant Patients with CMV-Positive Donors
This clinical trial studies the prevention of infection in patients who are negative for the virus but receive stem cells from a positive donor. This specific situation creates increased risk for infection after transplantation.
Inclusion criteria: Participants must be 18 years or older and undergoing their first allogeneic hematopoietic cell transplant. Before transplant, they must test negative for IgG antibodies while their donor tests positive. Participants must provide written consent and not have viral presence in blood requiring antiviral treatment within 5 days before starting study medication.
Exclusion criteria: Patients with different types of infections unrelated to the virus, those who have not received allogeneic stem cell transplant, those outside the specified age range, and vulnerable populations are excluded.
Study focus: The trial evaluates how well letermovir prevents infection during the critical 14-week period after transplant. Regular monitoring assesses infection incidence, effectiveness of prevention, adverse events, and recovery of neutrophils and platelets. Follow-up continues for 180 days post-transplant to track any infections and duration of any required antiviral treatment.
Investigational drugs: Letermovir is administered as PREVYMIS 240 mg film-coated tablets taken orally for 14 weeks. It works by inhibiting the viral DNA terminase complex, which is essential for viral replication.
Study on Prenatal Treatment of Congenital Cytomegalovirus Infection with Letermovir and Valaciclovir for Pregnant Women with CMV-Infected Fetuses
This trial compares two treatments for congenital infection: letermovir and valaciclovir. The study focuses on pregnant women who contracted the virus in the first trimester and are carrying an infected fetus.
Inclusion criteria: Participants must be pregnant women aged 18 or older in their second trimester (13-26 weeks) with either termination of pregnancy planned for fetal abnormality or a fetus infected between 15-28 weeks of pregnancy confirmed by positive viral test in amniotic fluid. They must have no evidence of placental dysfunction, be affiliated with social security or health insurance, provide written consent, and be willing to comply with study visits. For Step 2, they must have had infection in the first trimester, and the fetus must not have severe cerebral abnormalities on ultrasound.
Exclusion criteria: Men, those not pregnant or not in second trimester, those without an infected fetus, and vulnerable populations are excluded.
Study focus: The primary goal is to determine if letermovir can increase the chances of a newborn having a negative test at birth compared to valaciclovir. The study measures transfer of letermovir through the placenta, its accumulation in amniotic fluid and placenta, and concentration in fetal blood. Researchers monitor fetal and maternal health through regular ultrasounds, possibly MRI scans, and assess overall newborn health and development.
Investigational drugs: Letermovir (MK-8228) is being tested for its ability to transfer from mother to fetus and accumulate in amniotic fluid and placenta. Valaciclovir, a medication commonly used to treat viral infections, serves as the comparison treatment. Both are administered orally.
Study on Preventing Cytomegalovirus Infection in Stem Cell Transplant Patients Using Cytolytic T Lymphocytes
This trial investigates prevention of infection in patients who have undergone hematopoietic stem cell transplantation from HLA-identical family donors and do not have medication available for prevention. The study uses advanced cellular immunotherapy with Cytolytic T Lymphocytes.
Inclusion criteria: Participants must be adults over 18 years old who have received a transplant of blood-forming cells from a family donor with matching tissue type. The donor must be suitable according to established criteria and sign consent to participate. Patients must not be candidates for letermovir medication. The cell source can be from bloodstream or bone marrow. The donor must have been exposed to the virus. Women must have a negative pregnancy test. Written consent from patient or legal representative is required. There must be evidence of blood-forming cell recovery after transplant, shown by specific white blood cell counts.
Exclusion criteria: Patients with different types of infections, those who have not undergone allogeneic transplant, those without an HLA-identical familial donor, those outside the specified age range, and vulnerable populations are excluded.
Study focus: The trial evaluates how effectively CTL treatment reduces infection occurrence within the first 100 days after transplant compared to historical data. Researchers monitor infection incidence, need for further treatment, and presence of specific immune cells that remember the virus through weekly blood tests and regular health assessments up to Week 15.
Investigational drugs: Cytolytic T Lymphocytes are special immune cells designed to target and destroy virus-infected cells. These cells are administered through an injection to help prevent infection in this specific patient population.
Study on Ganciclovir and Valganciclovir for Preventing Cytomegalovirus in High-Risk Heart Surgery Patients
This study focuses on patients who have undergone major heart surgery and are at high risk of developing infection. The research investigates whether antiviral medications can prevent the virus from causing illness in otherwise healthy patients who spent three or more days in intensive care after surgery.
Inclusion criteria: Participants must provide written informed consent, be 18 years or older, have had major heart surgery in the last 90 days, and have stayed in the ICU for at least 72 hours after surgery. Female participants of childbearing potential must have a negative pregnancy test and agree to use reliable contraception during the study and for one month afterward. Male participants must use reliable contraception if sexually active with women of childbearing potential during the study and for three months afterward. Participants must be willing and able to follow the study schedule including visits, treatment plans, and lab tests.
Exclusion criteria: Patients who did not spend at least 3 days in the cardiac surgery ICU, do not have detectable virus in their blood, are not immunocompetent (have normally functioning immune systems), or have not undergone major heart surgery are excluded.
Study focus: The study evaluates how effective ganciclovir and valganciclovir are in preventing infection by measuring the number of days patients remain alive, out of ICU, and free from severe complications. Participants receive either the antiviral medication or a placebo for 14 days, with close monitoring throughout and for 30 days afterward to assess immune response and viral presence in blood.
Investigational drugs: Ganciclovir and valganciclovir are antiviral medications designed to prevent the virus from causing illness. The treatment is given to patients showing signs of the virus in their system to stop it from becoming a more serious problem.
Study on the Effectiveness and Safety of mRNA-1647 Vaccine for Preventing Cytomegalovirus in Healthy Individuals Aged 16 to 40
This trial studies a vaccine called mRNA-1647 designed to help the body build immunity. The vaccine uses mRNA (a special type of genetic material) to instruct cells to produce proteins that trigger an immune response.
Inclusion criteria: Participants must be females aged 16 to 40 years who can follow study procedures. Those aged 20 or older must have or expect to have direct contact with at least one child aged 5 years or younger (such as being a parent or providing childcare for at least 8 hours weekly) within 7 months after the first vaccine dose. For those never infected (seronegative), they must test negative for antibodies at screening. For those previously infected (seropositive), they must test positive for IgG antibodies. Written consent is required. Participants must be willing to attend all study visits and follow-up procedures for the 30-month study period. Females of childbearing potential must have a negative pregnancy test at screening and on the day of first vaccine dose, and must use effective birth control or abstain from activities that could lead to pregnancy from 28 days before first dose until 3 months after third dose.
Exclusion criteria: Males, those with current or past infection, those not within the specified age range, and vulnerable populations cannot participate. The study specifically focuses on females who are seronegative.
Study focus: The trial evaluates how well the vaccine works in preventing infection and assesses its safety and how the body reacts to it. Participants receive three vaccine injections over time. The study monitors immune response through regular blood samples and tracks any side effects. Follow-up continues for approximately 30 months to assess long-term effects.
Investigational drugs: mRNA-1647 is a vaccine that uses messenger RNA to teach the body’s immune system to recognize and fight the virus. The vaccine is given in three doses through injections into the muscle. It is being tested specifically for preventing infection in healthy individuals aged 16 to 40 years old who have never been exposed to the virus.
Study on Valaciclovir to Prevent Congenital CMV Infection in Pregnant Women with First Trimester CMV Infections
This trial investigates using valaciclovir to prevent transmission of the virus from pregnant mothers to their babies when the mother contracts the virus for the first time in the first trimester of pregnancy.
Inclusion criteria: Participants must provide voluntary written informed consent, be 18 years or older, have a proven first trimester primary infection, and be female.
Exclusion criteria: Males, those not pregnant, not in first trimester, or without primary infection during pregnancy cannot participate. Those outside the specified age range or not considered part of a vulnerable population are also excluded.
Study focus: The trial monitors the health and safety of both mother and baby throughout pregnancy and after birth. This includes regular ultrasound and MRI scans to look for signs of virus transmission to the baby, blood tests to check liver and kidney function, and postnatal monitoring of the baby’s health including hearing tests and developmental assessments up to five years of age. The study examines whether valaciclovir can effectively prevent transmission during pregnancy.
Investigational drugs: Valaciclovir is administered as 500 mg film-coated tablets taken orally. It works by stopping the virus from multiplying, which can reduce the chance of the baby becoming infected. The study follows participants through pregnancy and continues monitoring the child’s development for several years after birth.
Summary
The 10 ongoing clinical trials for cytomegalovirus infection represent a diverse range of research approaches across multiple European countries. The studies are distributed across Belgium, Estonia, Finland, France, Germany, Italy, Netherlands, Poland, Slovenia, and Spain, with France and Spain hosting the most trials.
Several notable patterns emerge from these studies. Transplant recipients represent a major focus, with multiple trials investigating prevention and treatment in kidney, heart, and stem cell transplant patients. Letermovir appears frequently as an investigational drug across several trials, being tested both alone and in combination with other antivirals in various patient populations. Another significant area of research involves pregnant women, with three separate trials examining ways to prevent transmission to unborn babies using medications like valaciclovir.
The research encompasses both traditional antiviral medications and innovative approaches, including cellular immunotherapy using specially designed T cells and a novel mRNA vaccine (mRNA-1647) being tested in healthy individuals. The trials vary in their target populations from high-risk surgical patients to healthy young women who may become pregnant, reflecting the broad impact of this virus across different patient groups.
These studies aim to address critical gaps in prevention and treatment, particularly for patients whose immune systems are compromised after transplantation and for protecting babies from congenital infection during pregnancy.
