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

NCT ID: NCT01284582

Last Updated: 2012-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HDL Drug Safety

Keywords

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CETP Vaccine Cholesterol Inhibition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ATH03 Group A

ATH03, 10 µg, 0.2% Alum

Group Type EXPERIMENTAL

ATH03

Intervention Type BIOLOGICAL

4 vaccinations

ATH03 Group B

ATH03, 30 µg, 0.2% Alum

Group Type EXPERIMENTAL

ATH03

Intervention Type BIOLOGICAL

4 vaccinations

ATH03 Group C

ATH03, 100 µg, 0.2% Alum

Group Type EXPERIMENTAL

ATH03

Intervention Type BIOLOGICAL

4 vaccinations

Interventions

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ATH03

4 vaccinations

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Clinically relevant pathological findings
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Affiris AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Achim Schneeberger, MD

Role: STUDY_DIRECTOR

Affiris AG

Locations

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Department for Clinical Pharmacology Medical University Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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AFF007

Identifier Type: -

Identifier Source: org_study_id