Re-boosting of HIV-1 Infected Subjects With Vacc-4x
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 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|
- 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
- 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
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
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).
Two re-boost immunisations with adjuvant and vacc-4x, one at week 1 and one at week 3.
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.
|United States, California|
|UCLA CARE Center|
|Los Angeles, California, United States, 90035|
|UC Davis Medical Center|
|Sacramento, California, United States, 95817|
|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|
|Istituto San Raffaele|
|Milano, Italy, 20127|
|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|
|Harrison Wing St Thomas' Hospital|
|London, United Kingdom, SE1 7EH|
|Study Director:||Vidar Wendel-Hansen, Dr. med||Bionor Pharma ASA, Kronprinsesse Märthas Plass 1, P.O. Box 1477 Vika, NO-0116 Oslo, Norway|