The aim of the present study is to determine the effect of vaccination on anti-oxLDL antibodies in man.
ID
Source
Brief title
Condition
- Other condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
Hypercholesterolemie
Research involving
Sponsors and support
Intervention
Outcome measures
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
urinalysis)
- Vital signs (pulse rate, systolic blood pressure and diastolic blood pressure)
- Electrocardiogram (ECG) (heart rate (HR), PR, QRS, QT, QTc)
Secondary outcome
Not Applicable
Background summary
Atherosclerosis is the main cause of cardiovascular disease. Low density
lipoprotein (LDL) plays an important role in atherosclerosis: after being
oxidized in the vascular wall, it is phagocytosed by macrophages, forming foam
cells and stimulating the overall inflammatory process. Animal research has
demonstrated that the 13-valent pneumococcal polysaccharide conjugate vaccine
that is currently used in clinical practice can induce immunoglobin M (IgM)
antibodies against these oxidized LDL (oxLDL) particles, which resulted in a
reduction of atherosclerotic lesion size.
Study objective
The aim of the present study is to determine the effect of vaccination on
anti-oxLDL antibodies in man.
Study design
Randomized, double-blind, placebo-controlled, single center study
Study burden and risks
Burden: measurements, blood and urine sampling, lifestyle restrictions and time
investment.
Risks: potential adverse events caused by Prevenar
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
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
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-005650-35-NL |
| CCMO | NL56174.058.16 |