Sacramento, California 95817

  • 1 Infection

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

CT-BI Vacc-4x 2012/1


NCT ID:

NCT01712256


Secondary ID:


Study Acronym:

Re-boost


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

63 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bionor Immuno AS


Oversight 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


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

33


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:December 2012
Completion Date:January 2014
Completion Type:Actual
Primary Completion Date:January 2014
Primary Completion Type:Actual
Verification Date:January 2014
Last Changed Date:January 13, 2014
First Received Date:October 16, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Vacc-4x effect on viral load set-point
Time Frame:37 weeks
Safety Issues:True
Description: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.
Outcome Type:Primary Outcome
Measure:Vacc-4x effect on immune response
Time Frame:37 weeks
Safety Issues:False
Description:Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1
Outcome Type:Secondary Outcome
Measure:CD4 counts
Time Frame:37 weeks
Safety Issues:True
Description:Effect of a re-boost with Vacc-4x on CD4 counts
Outcome Type:Secondary Outcome
Measure:Delayed Type Hypersensitivity test(DTH)
Time Frame:37 weeks
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame:37 weeks
Safety Issues:True
Description:To evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events
Outcome Type:Secondary Outcome
Measure:CD8 counts
Time Frame:37 weeks
Safety Issues:False
Description:Effect of a re-boost with Vacc-4x on CD8 counts

Study Interventions

Intervention Type:Biological
Name:Vacc-4x
Description:Two re-boost immunisations with adjuvant and vacc-4x, one at week 1 and one at week 3.
Arm Name:Re-boosting with Vacc-4x

Study Arms

Study Arm Type:Experimental
Arm Name:Re-boosting with Vacc-4x
Description: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).

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bionor Immuno AS

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Kran AM, Sommerfelt MA, Baksaas I, Sørensen B, Kvale D. Delayed-type hypersensitivity responses to HIV Gag p24 relate to clinical outcome after peptide-based therapeutic immunization for chronic HIV infection. APMIS. 2012 Mar;120(3):204-9. doi: 10.1111/j.1600-0463.2011.02843.x. Epub 2011 Nov 27.
PMID:22339677
Reference Type:Reference
Citation:Lind A, Sommerfelt M, Holmberg JO, Baksaas I, Sørensen B, Kvale D. Intradermal vaccination of HIV-infected patients with short HIV Gag p24-like peptides induces CD4 + and CD8 + T cell responses lasting more than seven years. Scand J Infect Dis. 2012 Aug;44(8):566-72. Epub 2012 Feb 19.
PMID:22339485
Reference Type:Reference
Citation:Jones T. Vacc-4x, a therapeutic vaccine comprised of four engineered peptides for the potential treatment of HIV infection. Curr Opin Investig Drugs. 2010 Aug;11(8):964-70.
PMID:20721838
Reference Type:Reference
Citation:Kran AM, Sørensen B, Sommerfelt MA, Nyhus J, Baksaas I, Kvale D. Long-term HIV-specific responses and delayed resumption of antiretroviral therapy after peptide immunization targeting dendritic cells. AIDS. 2006 Feb 28;20(4):627-30.
PMID:16470131

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.