CMV Glycoprotein B (gB) Vaccine Long Term Antibody Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Viraemia

Keywords

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Cytomegalovirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul D Griffiths

Role: PRINCIPAL_INVESTIGATOR

UCL

Locations

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Royal Free Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND

PMID: 21481708 (View on PubMed)

Other Identifiers

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2012-002767-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UCL 12/0161

Identifier Type: -

Identifier Source: org_study_id