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CMV Glycoprotein B Vaccine in Allograft Recipients

NCT00299260 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2010-04-19

No results posted yet for this study

Summary

Patients who receive transplants are at increased risk of developing serious cytomegalovirus (CMV) infections because they have a decreased immune system. The purpose of this study is to evaluate the safety and immune response of a CMV vaccine in patients (18 years old and older) who are awaiting a transplant. Following immunization with vaccine or placebo (inactive substance), patients will be followed for the development of immune responses to CMV and for evidence of CMV infection following transplantation. One hundred forty eligible patients will receive 3 injections of the CMV gB vaccine or 3 doses of placebo during 5 visits. Participants will participate in the study for approximately 7 months (if they do not undergo a transplant) or 10 months (if they undergo a transplant).

Conditions

  • Cytomegalovirus Infections

Interventions

BIOLOGICAL

CMV gB vaccine

20 micrograms

DRUG

Placebo

normal saline

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University College, London

    lead OTHER

Principal Investigators

  • Paul D Griffiths, MD DSc · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-09-30
Completion
2011-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299260 on ClinicalTrials.gov