Pneumococcal vaccine against atherosclerosis|
|- candidate number||24708|
|- NTR Number||NTR5981|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-jul-2016|
|- Secondary IDs||CHDR1503 |
|- Public Title||Pneumococcal vaccine against atherosclerosis|
|- Scientific Title||Proof-of-pharmacology clinical trial on a vaccine that elicits a protective humoral immune response against oxidized low density lipoprotein oxidized low density lipoprotein|
|- hypothesis||We hypothesize that prevenar 13 elicits a humoral immune response against oxidized low density lipoprotein|
|- Healt Condition(s) or Problem(s) studied||Atherosclerosis |
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following 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
|- Exclusion criteria||A potential subject who meets any of the following criteria will be excluded from participation in this study:|
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 splenectomy.
5. 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).
6. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
7. 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.
8. Participation in an investigational drug study within 3 months prior to screening.
9. Loss or donation of blood over 500 mL within three months (males)prior to screening.
10. 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.
11. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
12. Unwillingness or inability to comply with the study protocol for any other reason.
13. Active infection at the time of baseline visit, as evidence by either a body temperature >37.5 °C.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||4-apr-2016|
|- planned closingdate||1-okt-2017|
|- Target number of participants||24|
|- Primary outcome||Efficacy endpoints|
- Total IgG, IgM, immunoglobin E (IgE), immunoglobin A (IgA) titers
- Anti-oxLDL IgG, IgM, IgE, IgA titers
- Anti-pneumococcal wall polysaccharide IgG, IgM, IgE, IgA titers
- OxLDL levels
- Immunoglobin (Ig)-oxLDL complexes
- Total serum cholesterol, LDL, HDL, triglycerides and lipoprotein(a) (Lp(a))
Tolerability / safety endpoints
- Treatment-emergent (serious) adverse events (S)AEs
- Concomitant medication
- Clinical laboratory tests (haematology, chemistry (including cortisol and aldosterone) and
- Vital signs (pulse rate, systolic blood pressure and diastolic blood pressure)
- Electrocardiogram (ECG) (heart rate (HR), PR, QRS, QT, QTc)
|- Secondary outcome||N.A.|
|- Timepoints||Week 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 44, 56 and 68|
|- Trial web site||N.A.|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Centre for Human Drug Research|
|- CONTACT for SCIENTIFIC QUERIES|| Centre for Human Drug Research|
|- Sponsor/Initiator ||Centre for Human Drug Research (CHDR)|
(Source(s) of Monetary or Material Support)
|- Brief summary||In this study, 24 healthy subjects will undergo placebo-controlled injections with Prevenar 13. The humoral response against oxLDL will be measured, as well as the effect on blood cholesterol levels.
Recruitment will take place in the Netherlands
|- Main changes (audit trail)|
|- RECORD||28-jul-2016 - 16-sep-2016|
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