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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT01284582
First received: January 25, 2011
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
HDL
Drug Safety
Biological: ATH03
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: 264 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 264 days ] [ Designated as safety issue: No ]
  • Response to the various applied doses of ATH03 [ Time Frame: 264 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Clinically relevant pathological findings
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284582

Locations
Austria
Department for Clinical Pharmacology Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Affiris AG
Investigators
Study Director: Achim Schneeberger, MD Affiris AG
  More Information

No publications provided

Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT01284582     History of Changes
Other Study ID Numbers: AFF007
Study First Received: January 25, 2011
Last Updated: October 4, 2012
Health Authority: Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care

Keywords provided by Affiris AG:
CETP
Vaccine
Cholesterol
Inhibition

ClinicalTrials.gov processed this record on April 17, 2014