Re-boosting of HIV-1 Infected Subjects With Vacc-4x (Re-boost)

January 11, 2017 updated by: Bionor Immuno AS

Re-boosting of Subjects Previously Included in the CT BI-Vacc-4x 2007/1 Study. An Open, Multicenter, Immunogenicity, Follow-up Re-boosting Study With Vacc-4x in Subjects Infected With HIV-1 Who Have Maintained an Adequate Response to ART

During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV.

All patients participating in this trial have previously received the vacc-4x vaccine in order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The primary objective of this study is to evaluate if a re-boost with Vacc-4x could further reduce the amount of HIV-1 virus and increase the immune response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Human immunodeficiency virus (HIV) infects the cluster of differentiation 4 (CD4) subset of T-cells that are critical for initiating immune responses to infection. The level of CD4 cells in the blood is a marker of a patient's immunological status. During the course of an HIV infection, the number of CD4 cells decreases, resulting in reduced immunological responsiveness and ultimately immune deficiency.

Current management of an HIV infection includes antiretroviral therapy (ART). The advent of effective ART in 1996 led to a profound decrease in type 1 HIV (HIV-1)-associated morbidity and mortality in developed countries where ART has been available.

Despite the ability of ART to inhibit HIV-1 replication, it cannot cure infection, making ART a lifelong treatment that requires sustained compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects (e.g., metabolic toxicity and stigmatizing body fat redistribution) often require medication that further increases the inconveniences and financial burdens of HIV management. Of additional concern is the emergence of viruses resistant to ART that can result in treatment failure.

Vacc-4x is a peptide-based HIV therapeutic vaccine. The primary objective of Vacc-4x therapeutic vaccine is to strengthen the immune system's response to HIV p24. ART dramatically reduces the level of virus in circulation in the body, thereby allowing the immune system to focus on the therapeutic vaccine that is administered. ART also allows for the generation of new naïve CD4 cells that can be triggered by the therapeutic vaccine to generate new immune responses to HIV-1. Subjects are therefore immunized with Vacc-4x in the presence of ART to generate new HIV-specific immune responses that can sustain immunological fitness for prolonged periods when patients are removed from ART. It is likely that periodic boosting on ART will be required to sustain the immunotherapeutic effect - in this way ART may become an intermittent therapy.

This study is a follow-up, re-boosting study of Study CT-BI Vacc-4x 2007/1 (EudraCT Number 2007-006302-13) performed in US and Europe (UK, Germany, Spain and Italy). All subjects to be included have been given a therapeutic immunization with Vacc-4x during the CT-BI Vacc-4x 2007/1 study. During the study a reduction in the viral load set-point (mean viral load at Week 48 and Week 52, or if Week 52 not reached, mean viral load of the last two measured values before restart of ART) was seen in the Vacc-4x group compared to placebo group. Further stimulation of the immune system by re-boosting with Vacc-4x could reduce the viral load set-point further.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12157
        • EIPMED - Gesellschaft fűr epidemiologische und klinische Forschung in der Medizin mbH Rubensstrasse 125
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I; Immunologische Ambulanz, Siegmund-Freud-Str. 25
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Hamburg, Germany, 20099
        • ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George
  • Italy
      • Milano, Italy, 20127
        • Istituto San Raffaele
  • Spain
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08907
        • Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat.
  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Harrison Wing St Thomas' Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90035
        • UCLA CARE Center
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Completed immunization regimen with Vacc-4x active and stopped ART (at Week 28) in the CT-BI Vacc-4x 2007/1 study. (No re-start of ART is required).
  2. Documented pre-study CD4 cell count ≥400x106/L.
  3. Documented pre-study viral load < 300 000copies/mL.
  4. Signed informed consent.

Exclusion Criteria:

  1. Reported AIDS-defining illness within the previous year.
  2. Malignant disease.
  3. On chronic treatment with immune-suppressive therapy.
  4. Unacceptable values of the hematologic and clinical chemistry parameters, as judged by the Investigator, including creatinine values >1.5 x upper limit of normal (ULN), and AST, ALT and alkaline phosphatase (ALP) values >2.5 x ULN.
  5. Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis.
  6. Pregnant or breastfeeding women.
  7. Women of childbearing potential not using reliable and adequate contraceptive methods (defined as: use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; practicing abstinence; sterile) during the 5 weeks re-boosting period including the DTH and for 2 weeks after the DTH test, or sexually active male subjects with partners of child bearing potential unwilling to practice effective contraception during the 5 weeks re-boosting period including the DTH and for 12 weeks after the DTH-test.
  8. Current participation in other clinical therapeutic studies.
  9. Incapability of compliance to treatment protocol, in the opinion of the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Re-boosting with Vacc-4x
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Biological: Vacc-4x
Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
Other Names:
  • Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vacc-4x Effect on Viral Load Set-point
Time Frame: 37 weeks
Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.
37 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vacc-4x Effect on Immune Response Measured as CD4 Count
Time Frame: 36 weeks
Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1
36 weeks
Vacc-4x Effect on Immune Response Measured as CD8 Count
Time Frame: 36 weeks
Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1
36 weeks
Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration
Time Frame: 4 weeks
The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.
4 weeks
Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema
Time Frame: 4 Weeks
The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.
4 Weeks
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 37 weeks
To evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events
37 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bionor Immuno AS

Investigators

  • Study Director: Vidar Wendel-Hansen, Dr. med, Bionor Pharma ASA, Kronprinsesse Märthas Plass 1, P.O. Box 1477 Vika, NO-0116 Oslo, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

October 16, 2012

First Submitted That Met QC Criteria

October 19, 2012

First Posted (Estimate)

October 23, 2012

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-BI Vacc-4x 2012/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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