Clinical Trial Results:
Long term antibody response to CMV gB vaccine in patients requiring liver or renal transplant. A Phase II open, single-site study, in participants who received CMV gB vaccine or placebo in previous trial (CTA ref no 20363/0238/001-0010; REC ref no 5476; UCL sponsor no 05/009).
Summary
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EudraCT number |
2012-002767-95 |
Trial protocol |
GB |
Global end of trial date |
13 Jun 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Apr 2019
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First version publication date |
13 Apr 2019
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Other versions |
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Summary report(s) |
results for part 2 of this research results for part 1 of this research extra samples text extra samples summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
12/0161
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00299260 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University College London
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Sponsor organisation address |
Gower Street, London, United Kingdom, WC1E 6BT
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Public contact |
Paul Griffiths, University College London, 0207 8302997, p.griffiths@ucl.ac.uk
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Scientific contact |
Paul Griffiths, University College London, 0207 8302997, p.griffiths@ucl.ac.uk
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Sponsor organisation name |
University College London
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Sponsor organisation address |
Gower Street, London, United Kingdom, WC1E 6BT
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Public contact |
Samim Patel, University College London, 44 207 679 9320 , samim.patel@ucl.ac.uk
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Scientific contact |
Samim Patel, University College London, 44 207 679 9320 , samim.patel@ucl.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Oct 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Feb 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Jun 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The Primary objective is in two parts: 1) to see the antibody levels found months to years after patients entered the randomised placebo-controlled trial of a glycoprotein B vaccine against cytomegalovirus and 2) to have the previous samples retested using new and different methods which have been developed in different labs.
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Protection of trial subjects |
This refers to the main study:
Negative pregnancy test was required before each vaccine dose
Adverse and serious adverse events were tabulated and presented to a Data Safety Committee on six occasions.
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Background therapy |
Immunosuppressive drugs | ||
Evidence for comparator |
This refers to the main study: Placebo used to assess rate of side effects and immunogenicity | ||
Actual start date of recruitment |
03 Aug 2006
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 31
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Worldwide total number of subjects |
31
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EEA total number of subjects |
31
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
31
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Blood samples collected from UK patients who had previously volunteered for a placebo controlled RCT of CMV gB vaccine (report published Lancet 2011) starting 3 December 2013 and ending 9 February 2016. | |||||||||||||||
Pre-assignment
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Screening details |
Patients who had previously volunteered for a placebo controlled RCT of CMV gB vaccine | |||||||||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||
Blinding implementation details |
vaccine or matching placebo were dispensed by a pharmacist according to a randomisation code
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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vaccine seropositive | |||||||||||||||
Arm description |
CMV glycoprotein B plus MF59 adjuvant | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
glycoprotein B
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
20 micrograms plus MF59 adjuvant
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Investigational medicinal product name |
placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 ml normal saline
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Arm title
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placebo seronegative | |||||||||||||||
Arm description |
normal saline | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.9% saline
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Arm title
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vaccine seronegative | |||||||||||||||
Arm description |
CMV glycoprotein B plus MF59 adjuvant | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
CMV glycoprotein B plus MF59 adjuvant
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
20 micrograms plus MF59 adjuvant
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Arm title
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placebo seropositive | |||||||||||||||
Arm description |
Normal saline | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Normal saline
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Glycoprotein B antibodies
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Subject analysis set type |
Per protocol | |||||||||||||||||||||||||||
Subject analysis set description |
measurement of titre of antibodies to glycoprotein B
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End points reporting groups
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Reporting group title |
vaccine seropositive
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Reporting group description |
CMV glycoprotein B plus MF59 adjuvant | ||
Reporting group title |
placebo seronegative
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Reporting group description |
normal saline | ||
Reporting group title |
vaccine seronegative
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Reporting group description |
CMV glycoprotein B plus MF59 adjuvant | ||
Reporting group title |
placebo seropositive
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Reporting group description |
Normal saline | ||
Subject analysis set title |
Glycoprotein B antibodies
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
measurement of titre of antibodies to glycoprotein B
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End point title |
Titre of antibodies against glycoprotein B [1] | ||||||||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Months to years following vaccine
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis is not possible because of the small numbers, however, examination of the mean values for each group allows some general conclusions to be made. The seronegatives remain seronegative unless they develop viraemia. The seropositives may have a small boost in antibody level from viraemia. Once these effects of viraemia are taken into account, there is no substantial evidence that the vaccine was responsible for increasing antibody levels. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Until end of trial 13 June 2016
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Adverse event reporting additional description |
SAEs and SUSARS
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
10.0
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Reporting groups
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Reporting group title |
all patients
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Reporting group description |
all patients donating blood | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The scope of this sub-study was to look at the long-term antibody response to CMV gB vaccine in patients requiring liver or renal transplant who had participated in the trial: 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. No IMP was administered in the sub-study, one 40ml blood sample taken from the participants was the only intervention. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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17 Sep 2014 |
A substantial amendment was made on 17 September 2014 to the ethics committee to allow use of blood samples from patients recruited from the first study but who had since died and to analyse the samples overseas. This was approved on 10 October 2014. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Note that no clinical trial medication was given to patients during this follow up study. There was no prior hypothesis and only descriptive statistics were used to gain insight into natural history of this infection. |