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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01284582
First Posted: January 27, 2011
Last Update Posted: October 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Affiris AG
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 264 days ]
  • Response to the various applied doses of ATH03 [ Time Frame: 264 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT01284582     History of Changes
Other Study ID Numbers: AFF007
First Submitted: January 25, 2011
First Posted: January 27, 2011
Last Update Posted: October 5, 2012
Last Verified: October 2012

Keywords provided by Affiris AG:
CETP
Vaccine
Cholesterol
Inhibition

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs