HDLPhase 1NCT01284582
Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP)
A Phase 1 study testing ATH03 in people with HDL and Drug Safety, run by Affiris AG at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HDL, Drug Safety
- What is being tested?
- ATH03
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- May 2011to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- High density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl
Who cannot join
- Clinically relevant pathological findings
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department for Clinical Pharmacology Medical University Vienna
Vienna, State of Vienna, 1090
About this study
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
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.
Read the 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.
- Conditions
- HDL, Drug Safety
- Being tested
- ATH03
- Keywords
- CETP, Vaccine, Cholesterol, Inhibition
- Medical subject headings
- Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH03Biological
4 vaccinations
| Study group | Role | What they receive |
|---|---|---|
| ATH03 Group A | Experimental | ATH03, 10 µg, 0.2% Alum Receives: Biological: ATH03 |
| ATH03 Group B | Experimental | ATH03, 30 µg, 0.2% Alum Receives: Biological: ATH03 |
| ATH03 Group C | Experimental | ATH03, 100 µg, 0.2% Alum Receives: Biological: ATH03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: 264 days
Secondary outcomes (2)
Immunogenicity
Measured: 264 days
Response to the various applied doses of ATH03
Measured: 264 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HDLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiris AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Achim Schneeberger, MD, Study director, Affiris AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284582
- Sponsor's protocol ID
- AFF007
- Status last verified
- Oct 2012
- First submitted
- 25 Jan 2011
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01284582
- Acronym / sponsor ID
- AFF007
- Conditions
- HDL, Drug Safety
- Keywords
- CETP, Vaccine, Cholesterol, Inhibition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ATH03 Group A | Experimental | Biological: ATH03ATH03, 10 µg, 0.2% Alum |
| ATH03 Group B | Experimental | Biological: ATH03ATH03, 30 µg, 0.2% Alum |
| ATH03 Group C | Experimental | Biological: ATH03ATH03, 100 µg, 0.2% Alum |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males
- High density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl
Key exclusion criteria (1 listed)
- Clinically relevant pathological findings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATH034 vaccinations | Biological | ATH03 Group A, ATH03 Group B, ATH03 Group C |
Primary outcome
Number of adverse events
Time frame: 264 days
2 secondary outcomes
Immunogenicity
Time frame: 264 days
Response to the various applied doses of ATH03
Time frame: 264 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achim Schneeberger, MD study director
Affiris AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATH03 in people with HDL and Drug Safety, run by Affiris AG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: 264 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.