Clinical Trial Results:
A study to characterize the humoral and cellular response following simultaneous immunization with a neo-antigen (KLH) and a recall antigen (tetanus) in healthy volunteers
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Summary
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EudraCT number |
2017-000084-32 |
Trial protocol |
NL |
Global end of trial date |
09 May 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Jun 2022
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First version publication date |
15 Jun 2022
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Other versions |
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Summary report(s) |
CHDR1701_CSR Synopsis_01Nov2017 |
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 |
CHDR1701
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Centre for Human Drug Research
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Sponsor organisation address |
Zernikedreef 8, Leiden, Netherlands, 2333 CL
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Public contact |
Research Director, Centre for Human Drug Research, +31 715246400, clintrials@chdr.nl
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Scientific contact |
Research Director, Centre for Human Drug Research, +31 715246400, clintrials@chdr.nl
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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 |
01 Nov 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 May 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
09 May 2017
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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 |
Investigation of the immune response following immunization with Immucothel/Alhydrogel with or without tetanus. Per efficacy endpoint, the following parameters will be explored:
(a) Response size;
(b) Inter-individual variability of the response;
(c) Time course of the response.
Moreover, for each efficacy endpoint, it will be confirmed that a simultaneous administration of tetanus toxoid does not interfere (or only minimally) with the KLH response. This is valuable information to support simultaneous KLH/tetanus toxoid immunizations in the future intervention trial targeting OX40/OX40L. The data generated in the current study will allow selection of the most robust readout measures for quantification of the Immucothel/Alhydrogel-induced immune response in the future OX40/OX40L study and allow for a power analysis of studies using this model.
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Protection of trial subjects |
Immunization with KLH is not expected to yield any benefit for the participating subjects. Since all participating subjects have been immunized with tetanus toxoid(see in-and exclusion criteria), any tetanus toxoid immunization in this study should be considered a booster immunization. This means that the six subjects that will be immunized with the tetanus toxoid immunization will not need a booster immunization in the ten years after completing this study.
In terms of risks, all drugs that are used in the present study are widely used in the Netherlands, and, apart from temporary side effects associated with the administration of the drugs, it is unlikely to expect that the subjects will be at risk of unforeseen events. Furthermore, all study drug administrations will be done in the clinic under medical supervision, and the subjects remain in the clinic for at least 30 minutes to closely monitor any adverse signs. Therefore, the risks associated with study participation are considered minimal
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
27 Mar 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Netherlands: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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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) |
15
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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 |
Overall trial (overall period). | |||||||||
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Pre-assignment
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Screening details |
Healthy male subjects, 18 to 45 years of age (inclusive). Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum bodyweight of 50 kg. Anti-tetanus toxoid antibody titer ≥0.1 IU/mL. | |||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor | |||||||||
Blinding implementation details |
This study was performed in a double-blind fashion. The investigator, study staff, subjects, sponsor, and monitor remained blinded to the treatment assignment until database lock. The IMPs and its matching placebo were indistinguishable and were packaged and administered in the same way.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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immunisation treatments | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Tetanus toxoid
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
The dose of tetanus toxoid that is also used in clinical practice for repeated immunisation in adults (>40 IU in 0.5 mL) was also used in this study.
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Investigational medicinal product name |
Immucothel®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
Immucothel® was adsorbed into Alhydrogel®, In this study the administered dose of KLH was 0.1 mg adsorbed in 0.9 mg of Alhydrogel.
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
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 |
Solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
The IMPs and its matching placebo were indistinguishable and were packaged and administered in the same way.
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Baseline characteristics reporting groups
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Reporting group title |
Overall period
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Reporting group description |
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End points reporting groups
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Reporting group title |
immunisation treatments
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
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End point title |
12 IgM antibody titer against KLH [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 7 until day 28
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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: For results see attached document. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the specific treatment, and up to 5 days (96 hours) after study drug administration.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18
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Reporting groups
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Reporting group title |
immunisation treatments
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| None reported | |||
