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CMV hyperimmune globulin
CMV hyperimmune globulin provides passive immunization by supplying high-titer antibodies against cytomegalovirus (CMV) to prevent or reduce severity of CMV infection.
CMV hyperimmune globulin provides passive immunization by supplying high-titer antibodies against cytomegalovirus (CMV) to prevent or reduce severity of CMV infection. Used for Prevention of CMV disease in immunocompromised patients (e.g., transplant recipients, HIV-positive individuals), Treatment of CMV infection in immunocompromised hosts.
At a glance
| Generic name | CMV hyperimmune globulin |
|---|---|
| Also known as | CMV-IGIV, Cytogam |
| Sponsor | The George Washington University Biostatistics Center |
| Drug class | Hyperimmune globulin |
| Target | Cytomegalovirus (CMV) antigens |
| Modality | Small molecule |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
This is a polyclonal immunoglobulin preparation enriched with antibodies specific to CMV antigens. It works by providing immediate humoral immunity through passive transfer of pre-formed antibodies, which bind to CMV virions and infected cells, facilitating viral neutralization and clearance. This approach is particularly useful in immunocompromised patients who cannot mount an adequate endogenous immune response.
Approved indications
- Prevention of CMV disease in immunocompromised patients (e.g., transplant recipients, HIV-positive individuals)
- Treatment of CMV infection in immunocompromised hosts
Common side effects
- Infusion reactions
- Headache
- Fever
- Myalgia
- Thrombosis
Key clinical trials
- CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients (PHASE1, PHASE2)
- CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients (PHASE4)
- Association of T Gamma Delta-CD16+ Cells and Anti-CMV Immunoglobulins in the Prevention of CMV Infection (PHASE2)
- A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (PHASE3)
- Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection (PHASE4)
- The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease (NA)
- Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection (PHASE2, PHASE3)
- Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients (PHASE2, PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |