CMV Glycoprotein B (gB) Vaccine Long Term Antibody Response
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01883206|
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : October 27, 2017
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|
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|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|
- 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.
- 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
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
|Royal Free Hospital|
|London, United Kingdom, NW3 2QG|
|Principal Investigator:||Paul D Griffiths||UCL|