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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01712256
Recruitment Status : Completed
First Posted : October 23, 2012
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Bionor Immuno AS

Tracking Information
First Submitted Date  ICMJE October 16, 2012
First Posted Date  ICMJE October 23, 2012
Results First Submitted Date  ICMJE January 11, 2017
Results First Posted Date  ICMJE March 6, 2017
Last Update Posted Date March 6, 2017
Study Start Date  ICMJE December 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2012)
  • Vacc-4x effect on viral load set-point [ Time Frame: 37 weeks ]
    The effect of Re-boost with Vacc-4x on the viral load set-point obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1 by measuring viral load before and after reboosting.
  • Vacc-4x effect on immune response [ Time Frame: 37 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
  • 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
  • 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
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2012)
  • CD4 counts [ Time Frame: 37 weeks ]
    Effect of a re-boost with Vacc-4x on CD4 counts
  • Delayed Type Hypersensitivity test(DTH) [ Time Frame: 37 weeks ]
    In vivo immunogenicity of Vacc-4x by delayed-type hypersensitivity (DTH) and to compare the DTH response to the DTH response observed in the initial study; CT-BI Vacc-4x 2007/1
  • 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
  • CD8 counts [ Time Frame: 37 weeks ]
    Effect of a re-boost with Vacc-4x on CD8 counts
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Re-boosting of HIV-1 Infected Subjects With Vacc-4x
Official Title  ICMJE 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
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE Biological: Vacc-4x
Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
Other Name: Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13
Study Arms  ICMJE 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.
Intervention: Biological: Vacc-4x
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2014)
33
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2012)
35
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 63 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01712256
Other Study ID Numbers  ICMJE CT-BI Vacc-4x 2012/1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party Bionor Immuno AS
Study Sponsor  ICMJE Bionor Immuno AS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vidar Wendel-Hansen, Dr. med Bionor Pharma ASA, Kronprinsesse Märthas Plass 1, P.O. Box 1477 Vika, NO-0116 Oslo, Norway
PRS Account Bionor Immuno AS
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP