Pneumococcal vaccine against atherosclerosis

Completed

• Conditions: Atherosclerosis

• Registration Number: NL-OMON21732
• Lead Sponsor: .A.

Brief Summary

.A.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 aldosterone) and<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)<br>