E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
The Cytomegalovirus (CMV)is an ubiquitous linear double-stranded deoxyribonucleic acid (DNA) virus belonging to the Herpes virus family. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050524 |
E.1.2 | Term | Cytomegalovirus antibody |
E.1.2 | System Organ Class | 100000004848 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The Primary objective is see the antibody levels found months to years after patients entered the randomised placebo-controlled trial of a glycoprotein B vaccine against cytomegalovirus and to have the previous samples retested using new and different methods which have been developed in different labs.
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E.2.2 | Secondary objectives of the trial |
The Secondary objective is to prepare monoclonal antibodies from the B lymphocytes of these patients and check their strength(potency). If highly potent antibodies are identified, we would like to consider developing them further to see if they can protect future transplant patients against cytomegalovirus. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Recipient of IMP (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.
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E.4 | Principal exclusion criteria |
1. Patient unable or unwilling to provide and sign an informed consent. 2. Patients known to be HIV positive. 3. Patients receiving anticoagulants in whom venesection is contraindicated.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be anti-gB titre level. As analysis of the results of the initial RCT suggested that these titres are normally distributed on a natural log scale, we will summarise the levels in each study group (placebo and vaccine) using a geometric mean and 95% confidence interval. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Single blood sample taken at time convenient to patients. |
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E.5.2 | Secondary end point(s) |
The secondary outcome measure will be neutralising antibody level. We will summarise the levels in each study group (placebo and vaccine) using a mean and 95% confidence interval. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Single blood sample taken at time convenient to patients |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial will be the date of the last visit by the last enrolled participant. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |