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CMV Glycoprotein B (gB) Vaccine Long Term Antibody Response

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ClinicalTrials.gov Identifier: NCT01883206
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:

The purpose of this study is to see how well the antibody levels found months to years after patients entered a previous randomised placebo-controlled trial of a glycoprotein B vaccine against cytomegalovirus have persisted and to have the previous samples retested using different methods which have been further developed in different laboratories.

Also, to prepare monoclonal antibodies from the B lymphocytes of these patients and define their strength. If potent antibodies are identified, the investigators would like to consider developing them further to see if they can protect future transplant patients against cytomegalovirus.


Condition or disease
Viraemia

Detailed Description:
This is a follow up study to a randomised controlled trial comparing a CMV glycoprotein B vaccine with placebo (Trial title: A Phase II Immunogenicity Trial Of Cytomegalovirus Glycoprotein B Vaccine In Allograft Candidate Recipients; CTA ref no 20363/0238/001-0010; REC ref no 5476; UCL sponsor no 05/009) in participants with Chronic renal or liver deficiency sufficient to require transplantation. The study provided encouraging results (data now unblinded and analysed) by reducing the amount of cytomegalovirus that vaccinated patients excreted in blood post transplant (Griffiths et al Lancet 2011). The titre of antibody made against glycoprotein B was a correlate of protection against duration of viraemia (i.e. reduction in CMV levels). 100% of patients given vaccine produced antibody against glycoprotein B although the titres decreased with time. The titres of CMV neutralising antibody were boosted in those with prior natural immunity. The titres of neutralising antibody were low among those who were initially seronegative. However, improved assays for CMV neutralising antibodies have now become available, so we wish to have the samples retested using these different methods. We will also send the blood samples taken in the previous study to the same labs for enzyme immunoassay for antibodies against glycoprotein B. This trial will approach patients that took part in the above referenced study for one further blood sample to determine their current antibody titres and to obtain their consent to test the samples taken in that previous study using these new improved antibody assays. Monoclonal antibodies will be made from purified B lymphocytes to study how these may bind and neutralise cytomegalovirus in the laboratory in order to develop antibodies as potential therapeutic agents.

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Long Term Antibody Response to CMV gB Vaccine in Patients Requiring Liver or Renal Transplant.
Study Start Date : September 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016



Primary Outcome Measures :
  1. The primary outcome measure will be anti-gB titre level. [ Time Frame: Day 1. ]
    The first exploratory analysis will plot antibody titre against time since RCT (Random Control Trial) enrolment by study group. This will be examined visually to ensure that it is reasonable to group together samples measured at different time points after the original RCT completed.


Secondary Outcome Measures :
  1. Titre of antibodies able to neutralise CMV. [ Time Frame: Day 1. ]
    Ability of monoclonal antibodies prepared from patients' B cells to neutralise CMV and to bind to glycoprotein B in an enzyme immunoassay.


Biospecimen Retention:   Samples With DNA
Serum, Lymphocytes.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients will be those that received vaccine or placebo in the Phase II Immunogenicity Trial Of Cytomegalovirus Glycoprotein B Vaccine In Allograft Candidate Recipients Study (CTA ref no 20363/0238/001-0010; REC (Research Ethics Committee)ref no 5476; UCL (University College London) sponsor no 05/009).
Criteria

Inclusion Criteria:

  1. Recipient of IMP (Investigational Medicinal product) (CMV gB vaccine or placebo) in trial 'Phase II Immunogenicity Trial Of Cytomegalovirus Glycoprotein B Vaccine In Allograft Candidate Recipients Study' (CTA ref no 20363/0238/001-0010; REC ref no 5476; UCL sponsor no 05/009).
  2. Informed consent must be obtained from the patient.

Exclusion Criteria:

1. Patient unable or unwilling to provide and sign an informed consent.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883206


Locations
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United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Paul D Griffiths UCL
Publications:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01883206    
Other Study ID Numbers: UCL 12/0161
2012-002767-95 ( EudraCT Number )
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by University College, London:
Cytomegalovirus
Additional relevant MeSH terms:
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Viremia
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes