Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD

NCT00278200 | Terminated Phase 1 Results

• 3 other identifiers: J0216P30CA006973NA_00046066
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells may help the body build an effective immune response. PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients who are being considered for solid organ transplant who are at risk for post-transplant lymphoproliferative disorder.

Conditions

Lymphoproliferative Disorder

Keywords

post-transplant lymphoproliferative disorder

Outcome Measures

Primary Outcomes (1)

• Efficacy of Vaccine as Assessed by T-cell Responses

  Percentage of participants with T-cell responses. For participants who were EBV-seronegative at enrollment, a response is defined as the appearance of EBV-specific T-cells at one month after the second injection. For participants who were EBV-seropositive at enrollment, a response is defined as a two-fold increase over baseline in the frequency of CD8+ T-cells responding to EBV latency antigens at any point during the first 67 days following the first injection.

  Up to 67 days

Secondary Outcomes (2)

• Adverse Events Associated With the Vaccine

  Up to 5 years

• Prevention of Primary Epstein-Barr Virus (EBV) Infection

  Up to 5 years

Study Arms (2)

EBV Seronegative

EXPERIMENTAL

Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.

Biological: Inactivated EBV-infected vaccine

EBV Seropositive

EXPERIMENTAL

Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.

Biological: Inactivated EBV-infected vaccine

Interventions

Inactivated EBV-infected vaccine BIOLOGICAL

EBV Seronegative; EBV Seropositive

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Being considered for a solid organ transplant * At high risk for post-transplant lymphoproliferative disorder PATIENT CHARACTERISTICS: * Body weight ≥ 25 kg * Karnofsky performance status 50-100% OR * Lansky performance status 50-100% * Not pregnant * Negative pregnancy test * Fertile patients must use contraception during and for 2 months after completion of study treatment * Hemoglobin ≥ 8 g/dL (erythropoietin allowed) * No history of autoimmune disease, including any of the following: * Systemic lupus erythematosus * Sarcoidosis * Rheumatoid arthritis * Glomerulonephritis * Vasculitis * No primary immunodeficiency * No HIV positivity PRIOR CONCURRENT THERAPY: * No corticosteroids for 1 month before and for 1 month after the first study vaccination, except for the following: * Physiologic steroid dosing (≤ 20 mg/day of prednisone or steroid equivalent) for adrenal insufficiency * Inhaled steroids

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Lymphoproliferative Disorders

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Richard Ambinder, MD, PhD
• Organization: Johns Hopkins University

rambind1@jhmi.edu

4109558839

Study Officials

• Richard F Ambinder, MD, PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2006
• First Posted: January 18, 2006
• Study Start: January 1, 2003
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 25, 2023
• Results First Posted: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)