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 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003601 |
E.1.2 | Term | Atherosclerosis |
E.1.2 | System Organ Class | 100000004866 |
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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 |
- To determine the specific immunoglobulin response against oxLDL after administration of a single 13-valent pneumococcal vaccine. |
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E.2.2 | Secondary objectives of the trial |
- To investigate if early revaccination with the 13-valent pneumococcal conjugate vaccine elicits an additional immune response against oxLDL - To investigate if late revaccination with the 13-valent pneumococcal conjugate vaccine elicits an additional immune response against oxLDL - The temporal resolution of immunoglobulin responses after vaccination after single, double and triple vaccination with the 13-valent pneumococcal conjugate vaccine. - To determine the induction of immunoglobulin-oxLDL complexes after vaccination with the 13-valent pneumococcal conjugate vaccine; - To determine the effect of vaccination and revaccination with the 13-valent pneumococcal conjugate vaccine on total serum cholesterol, (ox)LDL, HDL, triglycerides and Lp(a)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male, aged 18-45 without evidence of any active or chronic disease following a medical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry and urinalysis. 2. Able to participate and willing to give written informed consent and to comply with the study restrictions
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E.4 | Principal exclusion criteria |
1. Subjects vaccinated with a pneumococcus vaccine 2. Known allergy against any of the excipients of the Prevenar vaccine. 3. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder. 4. History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., skin basal or squamous cell carcinoma). 5. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening. 6. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. 7. Participation in an investigational drug study within 3 months prior to screening. 8. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening. 9. Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study. 10. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable). 11. Unwillingness or inability to comply with the study protocol for any other reason. 12. Active infection at the time of baseline visit, as evidence by either a body temperature >37.5 °C or CRP >10 mg/L.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the titer of elicited anti-oxLDL IgM antibodies. These antibodies have been shown to impact atherosclerotic lesion progression in non-clinical studies and are associated with atheroprotective effects in humans. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 1, 2, 3, 8, 12, 16, 20, 24, 32, 44, 56 and 68 |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
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.8.5 | 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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Last visit of last subject in the trial (LSLV) |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |