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HypercholesterolemiaPhase 1AFF012NCT02508896

Study Assessing Safety, Immunogenicity and LDLc -Lowering Activity of 2 PCSK9 Targeting AFFITOPE Vaccines in Healthy Subjects

A Phase 1 study testing AFFITOPE® AT04A+adjuvant, AFFITOPE® AT06A+adjuvant and Adjuvant without active component in people with Hypercholesterolemia, run by Affiris AG at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study AFF012 is a single blind, single-center, randomized, placebo-controlled, parallel group, phase I clinical trial of repeated administration by subcutaneous injection of a single dose of one of two different proprotein convertase subtilisin/kexin type 9 targeting AFFITOPE® vaccines or Placebo. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hypercholesterolemia
What is being tested?
AFFITOPE® AT04A+adjuvant, AFFITOPE® AT06A+adjuvant and Adjuvant without active component
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteAustria
Study dates
Jul 2015to 31 Aug 2017
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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects ≥ 18 years of age at time of study entry.
  • Fasting LDLc at screening.
  • Fasting triglycerides at screening.
  • Body weight > 50 kg and a body mass index (BMI) between 19 and 35.

Who cannot join

  • Treatment/change in treatment with medications known to influence HDLc, LDLc and total cholesterol concentrations
  • Planned life-style changes during the study period like increasing aerobic exercise activity, attempting to lose body weight or changing the smoking status.
  • History of autoimmune diseases.
  • History of malignancy
  • Active or passive vaccination
  • Blood donation
Show all 13Show fewer
  • History of severe hypersensitivity reactions and anaphylaxis.
  • History of allergic bronchial asthma.
  • Acquired or hereditary immunodeficiency.
  • Prior and/or current treatment with immune modulating drugs:
  • Subject has taken prescription lipid-regulating drugs
  • Treatment prior to screening with the following drugs: vitamin A derivatives and retinol derivatives for dermatologic treatment or any other drug known to influence cholesterol Levels
  • Infection with the human immunodeficiency Virus,Hepatitis B (HBsAg) or Hepatitis C.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Single-blind Phase 1 Study Assessing the Safety, Immunogenicity and Low Density Lipoprotein Cholesterol (LDLc)-Lowering Activity of 2 Different Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Targeting AFFITOPE® Vaccines in Healthy Subjects

Study AFF012 is a single blind, single-center, randomized, placebo-controlled, parallel group, phase I clinical trial of repeated administration by subcutaneous injection of a single dose of one of two different proprotein convertase subtilisin/kexin type 9 targeting AFFITOPE® vaccines or Placebo. This study will assess Safety, Immunogenicity and low density lipoprotein cholesterol-lowering activity of the two vaccines.

72 healthy subjects are divided into three test groups (2 treatment groups, 1 placebo group), each consisting of 24 subjects. The subjects are randomized to receive either of two AFFITOPEs® (AT04A or AT06A, adsorbed to 1 mg aluminium oxyhydroxide) or placebo (1 mg aluminium oxyhydroxide).

The study consists of 3 parts, part A, encompassing Visit 1 to Visit 8, covering 3 priming immunizations at a dose of 15μg at days 0, 28 and 56 and the immediate observation period extending to day 140; the prolonged observation period: part B, encompassing Visit 9 and Visit 10 at days 273 and 365; and part C consisting of 7 visits (V11 to V17). Study participants having received 3 priming vaccinations and having completed part B will receive in part C one boost immunization at a dose of 75μg, which will be applied one year after the 3rd immunization (day 420). Probands will proceed directly from part A to part B and to part C. Continuation of parts B and C will be considered based on the part A results, primarily the immunological results. The following scenarios apply (provided that there is no safety issue). None of the two treatment groups exhibits a vaccine-specific antibody response over the placebo group at Visit 8 - this will lead to termination of the trial. One of the two groups fails to exhibit a vaccine-specific antibody response over the placebo group at Visit 8 - this will lead to its discontinuation; the other treatment group and the placebo group will be continued.

Being tested
AFFITOPE® AT04A+adjuvant, AFFITOPE® AT06A+adjuvant, Adjuvant without active component
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AFFITOPE® AT04A+adjuvantBiological

    subcutaneous injection

  • AFFITOPE® AT06A+adjuvantBiological

    subcutaneous injection

  • Adjuvant without active componentBiological

    subcutaneous injection

Study groups in NCT02508896
Study groupRoleWhat they receive
AFFITOPE® AT04A+adjuvantExperimental3 injections of 15µg AFFITOPE® AT04A+adjuvant once every 4 weeks and 1 boost immunization at a dose of 75μg, which will be applied one year after the 3rd immunization
Receives: Biological: AFFITOPE® AT04A+adjuvant
AFFITOPE® AT06A+adjuvantExperimental3 injections of 15µg AFFITOPE® AT06A+adjuvant once every 4 weeks and 1 boost immunization at a dose of 75μg, which will be applied one year after the 3rd immunization
Receives: Biological: AFFITOPE® AT06A+adjuvant
Adjuvant without active componentPlacebo comparator3 injections of Placebo once every 4 weeks and 1 boost immunization which will be applied one year after the 3rd immunization
Receives: Biological: Adjuvant without active component

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence of any Serious Adverse Event (SAE)

    Evaluation of SAE being unlikely, possibly, probably or definitely related to the study vaccines Occurence of any Grade 3 or higher adverse Event (AE) Occurence of solicited local AEs Occurence of solicited systemic AEs Occurence of unsolicited non-serious AEs

    Measured: 21 months

Secondary outcomes (9)

  1. Immunological activity of AFFITOPE® AT04A: Titer of vaccination-induced antibodies

    Titer of vaccination-induced antibodies directed towards peptide components of the vaccine, the carrier, and the target proprotein convertase subtilisin/kexin type 9

    Measured: 21 months

  2. Immunological activity of AFFITOPE® AT06A: Titer of vaccination-induced antibodies

    Titer of vaccination-induced antibodies directed towards peptide components of the vaccine, the carrier, and the target proprotein convertase subtilisin/kexin type 9

    Measured: 21 months

  3. Mean Levels of Low Density Lipoprotein Cholesterol (LDLc)

    Change from baseline

    Measured: 21 months

  4. Mean Levels of High Density Lipoprotein Cholesterol (HDLc)

    Change from baseline

    Measured: 21 months

  5. Mean Levels of Very Low Density Lipoprotein (VLDL)

    Change from baseline

    Measured: 21 months

  6. Mean Levels of Total Cholesterol (TC)

    Change from baseline

    Measured: 21 months

  7. Mean Levels of Triglycerides (TG)

    Change from baseline

    Measured: 21 months

  8. Mean Levels of PCSK9

    Change from baseline

    Measured: 21 months

  9. Correlation analysis: Relating the strength of antibody responses to Lipid lowering effects

    Relating the strength of antibody responses to Lipid lowering effects

    Measured: 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionMay 2016
  4. Study completion31 Aug 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02508896
Sponsor's protocol ID
AFFiRiS 012
Other IDs
2015-001719-11, 2015
Acronym
AFF012
Status last verified
Oct 2017
First submitted
24 Jul 2015
Last updated
20 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Zeitlinger M, Bauer M, Reindl-Schwaighofer R, Stoekenbroek RM, Lambert G, Berger-Sieczkowski E, Lagler H, Oesterreicher Z, Wulkersdorfer B, Luhrs P, Galabova G, Schwenke C, Mader RM, Medori R, Landlinger C, Kutzelnigg A, Staffler G. A phase I study assessing the safety, tolerability, immunogenicity, and low-density lipoprotein cholesterol-lowering activity of immunotherapeutics targeting PCSK9. Eur J Clin Pharmacol. 2021 Oct;77(10):1473-1484. doi: 10.1007/s00228-021-03149-2. Epub 2021 May 10.

    PubMed 33969434

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AFFITOPE® AT04A+adjuvant, AFFITOPE® AT06A+adjuvant and Adjuvant without active component in people with Hypercholesterolemia, 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 4 inclusion and 13 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 20 Oct 2017. 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. Some participants in this study may receive a placebo. 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?

Occurence of any Serious Adverse Event (SAE) (time frame: 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02508896, which also lists 1 linked publication.

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 20 Oct 2017.

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