CMV Glycoprotein B (gB) Vaccine Long Term Antibody Response

October 25, 2017 updated by: University College, London

Long Term Antibody Response to CMV gB Vaccine in Patients Requiring Liver or Renal Transplant.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Paul D Griffiths, UCL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL 12/0161
  • 2012-002767-95 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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