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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014