Cytomegalovirus Immune Globulin for Cytomegalovirus

(SHIELD Trial)

Not yet recruiting at 1 trial location

Overseen By Camille Kotton, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether CytoGam® (Cytomegalovirus Immune Globulin Intravenous), administered after standard antiviral treatment, can prevent late CMV disease in individuals who have undergone a kidney or liver transplant. The focus is on those who received an organ from a CMV-positive donor but did not have CMV themselves before the transplant. Participants will either receive CytoGam® infusions or continue with their standard care. Ideal candidates have had a kidney or liver transplant and are at high risk for CMV disease. As a Phase 4 trial, CytoGam® is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

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 is the safety track record for Cytomegalovirus Immune Globulin Intravenous (Human)?

Research has shown that CytoGam® is generally safe. In studies, less than 6% of infusions caused unwanted side effects, indicating that most people tolerate the treatment well. CytoGam® is already approved to prevent cytomegalovirus (CMV) in some patients, further supporting its safety. Overall, CytoGam® seems to be a safe choice for those needing extra protection against CMV. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the use of Cytomegalovirus Immune Globulin Intravenous (Human), known as CytoGam®, because it offers a targeted approach for managing cytomegalovirus (CMV) infections. Unlike standard treatments that often involve antiviral medications, CytoGam® is a specialized immune globulin that directly boosts the body's immune response to CMV. This treatment is unique because it involves monthly infusions over three months, potentially providing a more sustained and targeted defense against the virus by enhancing the body's natural ability to fight it. This innovative approach might offer a new line of defense for individuals at risk of CMV complications.

What is the effectiveness track record for Cytomegalovirus Immune Globulin in preventing late CMV disease in transplant recipients?

Research has shown that CytoGam®, which participants in this trial may receive, effectively prevents CMV (cytomegalovirus) disease in kidney transplant recipients. Two clinical trials demonstrated that CytoGam® aids patients at high risk for CMV disease. The treatment strengthens the immune system with antibodies that specifically target CMV, helping the body fight the virus more effectively after a transplant. Previous studies also suggest that CytoGam® may enhance the immune response in transplant patients, leading to better health outcomes. ^{4 6 7 8 9}

Who Is on the Research Team?

Camille Kotton, MD, FIDSA, FAST

Principal Investigator

Massachusetts General Hospital

David Wojciechowski, DO

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40232941/

Twelve-Month Clinical and Cost Outcomes of Removal ... Conclusion: Removing CMV-IVIG from a heart transplant protocol was associated with cost avoidance without worsened outcomes in CMV DNAemia. CMV-IVIG likely does ...

2. cytogam.com cytogam.com/wp-content/uploads/2024/03/Cytogam-USA-PI-Feb-2023.pdf

CytoGam® Cytomegalovirus Immune Globulin Intravenous ... In two separate clinical trials, CytoGam® was shown to provide effective prophylaxis in renal transplant recipients at risk for primary CMV disease. In the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07009548

CytoGam for CMV Infection or Disease in Solid Organ ... Cytomegalovirus (CMV) is a significant opportunistic pathogen and a major cause of morbidity and mortality in solid organ transplant recipients. CytoGam ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0041134525003811

Revisiting the Biological Rationale for Cytomegalovirus ... Notably, CMVIG's in vitro effects on cellular immunity suggest its potential to improve outcomes, particularly in SOT recipients undergoing co- ...

5. cytogam.com cytogam.com/efficacy-cmv-igiv-vs-standard-igivs/

Efficacy - CMV-IGIV vs Standard IGIVs CYTOGAM May Demonstrate Enhanced Properties When Compared to Standard IGIVs2. CYTOGAM is a purified immune globulin (that is, a hyperimmune globulin) that ...

6. cytogam.com cytogam.com/safety/

CYTOGAM Has a Demonstrated Safety Profile CYTOGAM has a favorable safety profile, with an incidence of adverse events of <6.0% of all infusions. The most frequent adverse reactions observed during ...

7. fda.gov fda.gov/media/77671/download

Package Insert - CytoGam Recent studies of combined prophylaxis with CMV-IGIV and ganciclovir have shown reductions in the incidence of serious CMV associated disease in CMV ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3535874/

Preliminary Evaluation of the Safety and Efficacy ... We report that infusions of standard human intravenous immunoglobulin significantly increase CMV IgG titers and avidity indexes in pregnant women.

9. cytogam.com cytogam.com/

CYTOGAM - CYTOGAM helps provide additional CMV ... CYTOGAM® is an intravenous immunoglobulin containing standardized amount of antibody to cytomegalovirus. It is indicated for the prophylaxis of cytomegalovirus ...