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Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bionor Immuno AS
ClinicalTrials.gov Identifier:
NCT00659789
First received: April 14, 2008
Last updated: January 5, 2017
Last verified: November 2016

April 14, 2008
January 5, 2017
August 2008
June 2010   (Final data collection date for primary outcome measure)
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. [ Time Frame: From Week 28 to Week 52 ]
To evaluate the proportion of subjects who require resumption of ART between the interruption of ART at week 28 and end of study at week 52. [ Time Frame: Week 52 ]
Complete list of historical versions of study NCT00659789 on ClinicalTrials.gov Archive Site
  • Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths [ Time Frame: Up to week 52 ]
    Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.
  • Immunogenicity [ Time Frame: Week 1, week 18 and week 52 ]
    Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema
  • Effect of Vacc-4x on CD8 Counts [ Time Frame: Weeks 6,18,24,28,32,36,40,44,48,52. ]
    CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52
  • Time to Restart of ART for Vacc-4x Subjects Versus Placebo [ Time Frame: Between Week 28 to Week 52 ]
    Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)
  • Effects on Vacc-4x on HIV-1 RNA [ Time Frame: Weeks 24,28,32,36,40,44,48,52. ]
  • Safety and tolerability of Vacc-4x [ Time Frame: Several points throughout the study ]
  • Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) [ Time Frame: Several points throughout the study ]
  • Effect of Vacc-4x on CD8 counts and HIV viral RNA [ Time Frame: Several points throughout the study ]
  • Time to Restart of ART for Vacc-4x Subjects Versus Placebo [ Time Frame: Several points throughout the study ]
Not Provided
Not Provided
 
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
A Phase II, Randomized, Double-blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV-1 Who Have Maintained an Adequate Response to ART

Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore,ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV I Infection
  • Drug: 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.
  • Drug: Sterile water
    Sterile water is used in place of Vacc-4x and in place of Leukine
    Other Name: Placebo
  • Experimental: Vacc-4x
    Vacc-4x reconstituted in sterile water (0.1 mL) at a dose of 1.2mg per intradermal administration. Participants are given a total of 6 immunizations over 18 weeks (weeks 1, 2, 3, 4, 16, 18). Recombinant human granulocyte macrophage colony stimulating factor (rhuGM-CSF) Leukine (0.06mg in 0.1 mL) administered intradermally is used as a local adjuvant.
    Intervention: Drug: Vacc-4x
  • Placebo Comparator: Placebo
    Placebo injections consisting of sterile water (0.1 mL) in place of Vacc-4x. Placebo injections consisting of sterile water (0.1 mL) in place of Leukine.
    Intervention: Drug: Sterile water
Pollard RB, Rockstroh JK, Pantaleo G, Asmuth DM, Peters B, Lazzarin A, Garcia F, Ellefsen K, Podzamczer D, van Lunzen J, Arastéh K, Schürmann D, Clotet B, Hardy WD, Mitsuyasu R, Moyle G, Plettenberg A, Fisher M, Fätkenheuer G, Fischl M, Taiwo B, Baksaas I, Jolliffe D, Persson S, Jelmert O, Hovden AO, Sommerfelt MA, Wendel-Hansen V, Sørensen B. Safety and efficacy of the peptide-based therapeutic vaccine for HIV-1, Vacc-4x: a phase 2 randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2014 Apr;14(4):291-300. doi: 10.1016/S1473-3099(13)70343-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
June 2011
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-55
  • HIV positive at least one year
  • Clinically stable on ART for at least six months
  • Documented viral load less than 50 copies/mL for the last six months
  • Documented prestudy CD4 cell count equal or more than 400x10exp6/L
  • Nadir CD4 cell count equal or more than 200x10exp6/L
  • Signed informed consent

Exclusion Criteria:

  • Reported pre-study AIDS-defining illness within the previous year
  • Malignant disease
  • On chronic treatment with immuno-suppressive therapy
  • Unacceptable values of hematology and clinical chemistry parameters
  • Current chronic infection such as HCV and HBV or active tuberculosis
  • Pregnant or breastfeeding women
  • Not using safe contraceptive methods
  • Participation in other clinical trial
  • Incapability of compliance
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Italy,   Spain,   United Kingdom
 
 
NCT00659789
CT-BI Vacc-4x 2007/1
2007-006302-13 ( EudraCT Number )
13619 ( Other Identifier: FDA IND )
Yes
Not Provided
No
Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.
Bionor Immuno AS
Bionor Immuno AS
Not Provided
Principal Investigator: Richard Pollard, MD University of California at Davis, USA
Principal Investigator: Jürgen Rochstroh, MD Universitätsklinikum Bonn, Germany
Bionor Immuno AS
November 2016

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