Trial record 6 of 20 for:    affiris

Study Assessing Safety, Immunogenicity and LDLc -Lowering Activity of 2 PCSK9 Targeting AFFITOPE Vaccines in Healthy Subjects (AFF012)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT02508896
First received: July 24, 2015
Last updated: May 27, 2016
Last verified: May 2016
  Purpose

Study AFF011 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).

Over a treatment period of 8 weeks, each patient receives 3 injections of either an AFFITOPE® vaccine or Placebo.

The study consists of 2 parts, the main part: part A, encompassing Visit 1 to Visit 8, covering the 3 immunizations at days 0, 28 and 56 and the immediate observation period extending to day 140, and the prolonged observation period: part B, encompassing Visit 9 and Visit 10 at days 273 and 365. Probands will proceed directly from part A to part B. Continuation of part B 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.


Condition Intervention Phase
Hypercholesterolemia
Biological: AFFITOPE® AT04A+adjuvant
Biological: AFFITOPE® AT06A+adjuvant
Biological: Adjuvant without active component
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Occurence of any Serious Adverse Event (SAE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Immunological activity of AFFITOPE® AT04A: Titer of vaccination-induced antibodies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Titer of vaccination-induced antibodies directed towards peptide components of the vaccine, the carrier, and the target proprotein convertase subtilisin/kexin type 9

  • Immunological activity of AFFITOPE® AT06A: Titer of vaccination-induced antibodies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Titer of vaccination-induced antibodies directed towards peptide components of the vaccine, the carrier, and the target proprotein convertase subtilisin/kexin type 9

  • Mean Levels of Low Density Lipoprotein Cholesterol (LDLc) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline

  • Mean Levels of High Density Lipoprotein Cholesterol (HDLc) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline

  • Mean Levels of Very Low Density Lipoprotein (VLDL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline

  • Mean Levels of Total Cholesterol (TC) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline

  • Mean Levels of Triglycerides (TG) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline

  • Mean Levels of PCSK9 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline

  • Correlation analysis: Relating the strength of antibody responses to Lipid lowering effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Relating the strength of antibody responses to Lipid lowering effects


Enrollment: 72
Study Start Date: July 2015
Estimated Study Completion Date: December 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AFFITOPE® AT04A+adjuvant
3 injections of 15µg AFFITOPE® AT04A+adjuvant once every 4 weeks
Biological: AFFITOPE® AT04A+adjuvant
subcutaneous injection
Experimental: AFFITOPE® AT06A+adjuvant
3 injections of 15µg AFFITOPE® AT06A+adjuvant once every 4 weeks
Biological: AFFITOPE® AT06A+adjuvant
subcutaneous injection
Placebo Comparator: Adjuvant without active component
3 injections of Placebo once every 4 weeks
Biological: Adjuvant without active component
subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Treatment/change in treatment with medications known to influence HDLc, LDLc and total cholesterol concentrations
  2. Planned life-style changes during the study period like increasing aerobic exercise activity, attempting to lose body weight or changing the smoking status.
  3. History of autoimmune diseases.
  4. History of malignancy
  5. Active or passive vaccination
  6. Blood donation
  7. History of severe hypersensitivity reactions and anaphylaxis.
  8. History of allergic bronchial asthma.
  9. Acquired or hereditary immunodeficiency.
  10. Prior and/or current treatment with immune modulating drugs:
  11. Subject has taken prescription lipid-regulating drugs
  12. 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
  13. Infection with the human immunodeficiency Virus,Hepatitis B (HBsAg) or Hepatitis C.
  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: NCT02508896

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Affiris AG
Medical University of Vienna
Investigators
Principal Investigator: Markus Zeitlinger, MD Medical University of Vienna
  More Information

Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT02508896     History of Changes
Other Study ID Numbers: AFFiRiS 012  2015-001719-11 
Study First Received: July 24, 2015
Last Updated: May 27, 2016
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2016