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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bionor Immuno AS
ClinicalTrials.gov Identifier:
NCT01712256
First received: October 16, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Biological: Vacc-4x
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bionor Immuno AS:

Primary Outcome Measures:
  • Vacc-4x effect on viral load set-point [ Time Frame: 37 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1


Secondary Outcome Measures:
  • CD4 counts [ Time Frame: 37 weeks ] [ Designated as safety issue: Yes ]
    Effect of a re-boost with Vacc-4x on CD4 counts

  • Delayed Type Hypersensitivity test(DTH) [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Effect of a re-boost with Vacc-4x on CD8 counts


Enrollment: 33
Study Start Date: December 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Re-boosting with Vacc-4x
All patients previously participating in the CT-BI Vacc-4x 2007/1 study and completed immunization regimen with Vacc-4x active and stopped ART (at Week 28) (No re-start of ART is required).
Biological: Vacc-4x
Two re-boost immunisations with adjuvant and vacc-4x, one at week 1 and one at week 3.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 63 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01712256

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

Publications:
Responsible Party: Bionor Immuno AS
ClinicalTrials.gov Identifier: NCT01712256     History of Changes
Other Study ID Numbers: CT-BI Vacc-4x 2012/1
Study First Received: October 16, 2012
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Germany: Paul-Ehrlich-Institut
Germany: Ethics Commission
Italy: Ethics Committee
Spain: Spanish Agency of Medicines
Spain: Ethics Committee

Keywords provided by Bionor Immuno AS:
CD4
Clinical trial
Human immunodeficiency virus-1 (HIV-1)
HIV
Immunomodulary
Infection
Phase II
Re-boost
Vaccine
Vacc-4x

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on September 16, 2014