Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP)

Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP), in Healthy Male Subjects With High Density Lipoprotein Cholesterol (HDLc) Blood Concentrations Equal or Below 80 mg/dl

Phase 1 Study :Safety, Immunogenicity and Dose response of ATH03, a new vaccine against the cholesterol ester transfer protein (CETP), in healthy male subjects with high density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl.

Study Overview

• Status: Completed
• Conditions: HDL; Drug Safety
• Intervention / Treatment: Biological: ATH03

Detailed Description

This open-label Phase 1 study will be conducted in three groups of 12 subjects with HDLc blood concentrations equal or below 80 mg/dl at a single study center. 36 subjects will be enrolled.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department for Clinical Pharmacology Medical University Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy males
• High density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl

Exclusion Criteria:

• Clinically relevant pathological findings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATH03 Group A; ATH03, 10 µg, 0.2% Alum	Biological: ATH03; 4 vaccinations
Experimental: ATH03 Group B; ATH03, 30 µg, 0.2% Alum	Biological: ATH03; 4 vaccinations
Experimental: ATH03 Group C; ATH03, 100 µg, 0.2% Alum	Biological: ATH03; 4 vaccinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events	264 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity	264 days
Response to the various applied doses of ATH03	264 days

Collaborators and Investigators

• Sponsor: Affiris AG
• Investigators: Study Director: Achim Schneeberger, MD, AFFiRiS AG

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Cholesterol; Vaccine; CETP; Inhibition
• Other Study ID Numbers: AFF007