Cytomegalovirus Immune Globulin for Cytomegalovirus

(SHIELD Trial)

Recruiting at 1 trial location

Overseen By Lindsay Ventura, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Camille N. Kotton, MD

Disqualifiers: Multi organ transplants, Severe pulmonary disease, Neurodegenerative disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and/or kidney transplant.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Cytomegalovirus Immune Globulin Intravenous (Human) for preventing cytomegalovirus infections?

Research shows that Cytomegalovirus Immune Globulin can effectively reduce the risk of cytomegalovirus infections and related complications, such as interstitial pneumonia, in patients undergoing bone marrow and renal transplants. In one study, it provided complete protection against cytomegalovirus infection in bone marrow transplant recipients, and in another, it significantly reduced the incidence of cytomegalovirus disease in renal-transplant recipients. ^{1 2 3 4 5}

How does the drug Cytomegalovirus Immune Globulin differ from other treatments for cytomegalovirus?

Cytomegalovirus Immune Globulin is unique because it is a hyperimmune globulin specifically targeting cytomegalovirus, administered intravenously, and has shown effectiveness in preventing cytomegalovirus infection and interstitial pneumonia in bone marrow transplant patients. This drug provides targeted protection by delivering high levels of antibodies against the virus, which is different from standard intravenous immunoglobulins that are not specifically tailored for cytomegalovirus. ^{1 2 4 6 7}

Research Team

Camille Kotton, MD, FIDSA, FAST

Principal Investigator

Massachusetts General Hospital

David Wojciechowski, DO

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for liver and/or kidney transplant recipients at high risk of developing late Cytomegalovirus (CMV) disease. Participants must have completed standard antiviral treatment post-transplant.

Inclusion Criteria

Written informed consent obtained from the subject before any trial-related procedures

Able to do routine blood testing (normal care for transplant recipients)

I am at high risk for CMV and receiving a kidney or liver transplant from a CMV positive donor.

Exclusion Criteria

I have no history of heart attacks, irregular heartbeats, or significant ECG issues.

I have had a transplant, but it was not for my kidney or liver.

Any pre-transplant CMV serologic combinations besides CMV D+/R-

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CytoGam® infusions once a month for three months or standard care with monthly telephone calls

12 weeks

3 visits (in-person) for CytoGam® group, monthly calls for standard care group

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Biweekly blood tests

Treatment Details

Interventions

• Cytomegalovirus Immune Globulin Intravenous (Human)

Trial Overview The study tests if CytoGam®, a CMV Immune Globulin Intravenous (Human), given monthly for three months, can prevent late CMV disease in high-risk transplant patients after standard antiviral treatment.

Participant Groups

Group I: Arm A: CytoGam® Experimental Treatment 1 Intervention

Participants assigned to receive CytoGam® will receive an infusion once a month for three months at their study site. The infusion will be completed over an average of about 4 hours; these three visits will last about 5 hours. During these study staff will review concomitant medications and adverse events. Participants will be asked to have blood taken at infusion visits and 2 weeks after an infusion visit to check the level of CMV DNA in their blood.

Group II: Arm B: Standard of Care Active Control 1 Intervention

Participants assigned to Arm B, will be asked to complete a telephone call visit once a month. During these visits, a member of study staff will review concomitant medications and adverse events. Participants will be asked to have their blood taken every two weeks to check the level of CMV DNA.

Who Is Running the Clinical Trial?

Camille N. Kotton, MD

Lead Sponsor

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Kamada, Ltd.

Industry Sponsor

Trials

14

Recruited

790+

References

1. United States pubmed.ncbi.nlm.nih.gov

Intravenous immunoglobulin for modification of cytomegalovirus infections associated with bone marrow transplantation. Preliminary results of a controlled trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Prevention of cytomegalovirus infection by prophylaxis with an intravenous, hyperimmune, native, unmodified cytomegalovirus globulin. Randomized trial in bone marrow transplant recipients. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Intravenous immune globulin for prevention of cytomegalovirus infection and interstitial pneumonia after bone marrow transplantation. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Use of a polyvalent intravenous immunoglobulin or specific cytomegalovirus hyperimmunoglobulin for modification of cytomegalovirus infections and prevention of interstitial pneumonias following bone marrow transplantation]. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Use of cytomegalovirus immune globulin to prevent cytomegalovirus disease in renal-transplant recipients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

In vitro evaluation of cytomegalovirus-specific hyperimmune globulins vs. standard intravenous immunoglobulins. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Cytomegalovirus immune globulin and seronegative blood products to prevent primary cytomegalovirus infection after marrow transplantation. [2017]