Proof-of-pharmacology clinical trial on a vaccine that elicits a protective humoral immune response against oxidized low density lipoprotei

Phase 2

Completed

• Conditions: Hypercholesterolemie; Atherosclerosis; 10003216

• Registration Number: NL-OMON43410
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-03-05
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy endpoints<br /><br>- Total IgG, IgM, immunoglobin E (IgE), immunoglobin A (IgA) titers<br /><br>- Anti-oxLDL IgG, IgM, IgE, IgA titers<br /><br>- Anti-pneumococcal wall polysaccharide IgG, IgM, IgE, IgA titers<br /><br>- OxLDL levels<br /><br>- Immunoglobin (Ig)-oxLDL complexes<br /><br>- Total serum cholesterol, LDL, HDL, triglycerides and lipoprotein(a) (Lp(a))<br /><br>-<br /><br>Tolerability / safety endpoints<br /><br>- Treatment-emergent (serious) adverse events (S)AEs<br /><br>- Concomitant medication<br /><br>- Clinical laboratory tests (haematology, chemistry (including cortisol and<br /><br>aldosterone) and<br /><br>urinalysis)<br /><br>- Vital signs (pulse rate, systolic blood pressure and diastolic blood pressure)<br /><br>- Electrocardiogram (ECG) (heart rate (HR), PR, QRS, QT, QTc)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not Applicable</p><br>