CMV Glycoprotein B (gB) Vaccine Long Term Antibody Response

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.

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Key information

Conditions

Viraemia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Viremia Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Free Hospital

London, NW3 2QG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).
Informed consent must be obtained from the patient.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Jun 21, 2013
Registry last updated: Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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