NCT00299260

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 19, 2010

Status Verified

January 1, 2008

Enrollment Period

3.1 years

First QC Date

March 3, 2006

Last Update Submit

April 16, 2010

Conditions

Cytomegalovirus Infections

Keywords

cytomegalovirus, glycoprotein B vaccine, allograft

Outcome Measures

Primary Outcomes (2)

  • safety

    SAEs within 28 days of each vaccine dose

    28 days

  • immunogenicity

    antibody level one month after second dose of vaccine

    day 56

Secondary Outcomes (2)

  • viral load

    90 days

  • correlate of immune protection

    90 days

Study Arms (2)

vaccine

ACTIVE COMPARATOR

glycoprotein B plus MF59 adjuvant

Biological: CMV gB vaccine

placebo

PLACEBO COMPARATOR

normal saline

Drug: Placebo

Interventions

CMV gB vaccineBIOLOGICAL

20 micrograms

vaccine
PlaceboDRUG

normal saline

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent and/or assent must be obtained from the patient.
  • Patients must be 18 years of age or older.
  • Awaiting a liver or kidney transplant.
  • All female patients with childbearing potential must have a negative pregnancy test prior to each vaccination.
  • All females of childbearing potential must agree to use an effective barrier method of birth control while receiving the vaccine and for 30 days after completion of the course of vaccine. Other contraception in addition to barrier methods is permitted.
  • Among the CMV seropositives, HLA type compatible with tetramer assays (currently A2, A24, B7, B8, B35). (seronegatives of any HLA type are eligible).

You may not qualify if:

  • Patient unable or unwilling to provide and sign an informed consent or assent.
  • If a patient who is competent to give informed consent enters the trial but subsequently becomes incompetent, they will be withdrawn.
  • Pregnant or breastfeeding females.
  • Participation in another clinical trial of a vaccine or of a systemic drug in the 4 weeks preceding the first trial vaccination (participation in trials of medical devices/ procedures is allowed).
  • Planned participation in another clinical trial of a vaccine or of a systemic drug during the present trial period (participation in trials of medical devices/ procedures is allowed).
  • Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Blood or blood-derived products received in the past 3 months (except albumin).
  • Current thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  • Among the seropositives, HLA type incompatible with tetramer assays (seronegatives of any HLA type are eligible).
  • Requiring emergency transplant for fulminant liver failure.
  • Patients known to be HIV positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Medical School

London, NW3 2PF, United Kingdom

Location

Related Publications (1)

  • Griffiths PD, Stanton A, McCarrell E, Smith C, Osman M, Harber M, Davenport A, Jones G, Wheeler DC, O'Beirne J, Thorburn D, Patch D, Atkinson CE, Pichon S, Sweny P, Lanzman M, Woodford E, Rothwell E, Old N, Kinyanjui R, Haque T, Atabani S, Luck S, Prideaux S, Milne RS, Emery VC, Burroughs AK. Cytomegalovirus glycoprotein-B vaccine with MF59 adjuvant in transplant recipients: a phase 2 randomised placebo-controlled trial. Lancet. 2011 Apr 9;377(9773):1256-63. doi: 10.1016/S0140-6736(11)60136-0.

    PMID: 21481708DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Paul D Griffiths, MD DSc

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 6, 2006

Study Start

August 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2011

Last Updated

April 19, 2010

Record last verified: 2008-01

Locations

GB(1)