Immunoglobiulin-specific Prophylaxis of Citomegalovirus Infections in Immunocompromised Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

NCT07013370 | Recruiting FDA Drug

• 1 other identifier: 1105/2015_BG
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Human cytomegalovirus (CMV) is a globally prevalent, human-specific herpesvirus characterised by a lifelong latency after primary infection, an often asymptomatic reactivation and affecting up to 100% of adults based on region and age. CMV reactivation has serious risks for immunocompromised patients, especially those undergoing allogeneic hematopoietic stem cell transplantation (HSCT). In these patients, CMV can lead to graft failure, multiorgan disease, increased risk of other infections, GVHD, post-transplant lymphoproliferative disorders, and higher transplant-related mortality (TRM). Although antiviral prophylaxis, CMV infection occurs in 38-80% of HSCT recipients, but current antiviral drugs are insufficiently effective and they are associated with adverse effects. Furthermore, treatment failure is due to the high genetic variability of CMV. The protective role of virus-specific antibodies remains under debate. Some studies suggest that high neutralizing antibody titers protect transplant recipients from CMV, while others highlight the importance of T-cell responses. However, recent animal studies showed that humoral immunity alone can prevent CMV reactivation, even without T or NK cells. In solid-organ transplant patients, antibody titers ≥480 have been linked to reduced infection, shorter treatment, and full protection from CMV disease. Although the use of anti-CMV immunoglobulin remains controversial, the IRCCS Burlo Garofolo has used it as post-transplant prophylaxis and second-line treatment for over a decade. The main objective of their study was to assess whether CMV-specific immunoglobulin prophylaxis reduces CMV incidence and severity in pediatric HSCT patients. Secondary goals included evaluating its effect on transplant outcomes and its efficacy across different ethnic groups. A population pharmacokinetic (POP/PK) study was also conducted to better understand the drug's distribution and elimination and to identify factors influencing its pharmacokinetics in patients.

Conditions

Immunoglobulin Prophylaxis; Cytomegalovirus Infections; Allogeneic Hematopoietic Stem Cell Transplantation; Transplant-Related Disorder

Keywords

Cytomegalovirus; allo-HSCT; Transplant-Related mortality

Outcome Measures

Primary Outcomes (1)

• CMV reactivation and infection

  The rate of viral reactivation and infection in children undergoing all-HSCT

  12 months since allo-HSCT

Secondary Outcomes (4)

• Overall Survival

  12 months since allo-HSCT

• Hospital stay

  12 months since allo-HSCT

• Immunological recovery

  12 months since allo-HSCT

• GVHD incidence

  12 months since allo-HSCT

Study Arms (2)

Control Group

Pediatric allo-HSCT recipients who have not received CMV-specific immunoglobulin prophylaxis after transplantation.

Immunoprophylaxis Group

Pediatric allo-HSCT recipients who received an anti-CMV prophylaxis with immunoglobulin (Megalotect)

Biological: Anti-CMV immunoglobulins [Megalotect (R)]

Interventions

Anti-CMV immunoglobulins [Megalotect (R)] BIOLOGICAL

Children received an anti-CMV immunoglobulin to prevent viral infections

Immunoprophylaxis Group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children who underwent allogeneic HSCT due to any condition

You may qualify if:

• Children who underwent allogeneic HSCT due to any condition

You may not qualify if:

• Positive personal records of immunoglobulin-related adverse reactions
• CMV reactivation before the CMV-specific immunoglobulin prophylaxis onset
• adoptive cellular post-HSCT immunotherapy for any indication

Sponsors & Collaborators

• Antonello Di Paolo, M.D., Ph.D.: lead
• IRCCS Burlo Garofolo: collaborator

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Natalia Maximova, MD

  IRCCS Burlo Garofolo - Trieste - ITALY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Maximova, MD

CONTACT

+39-040.3785.111; natalia.maximova@burlo.trieste.it

Debora Curci, PhD

CONTACT

+39-040.3785.111; debora.curci@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pharmacology

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: June 2, 2025
• Primary Completion: December 31, 2025
• Study Completion: June 2, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

IT (1)