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

NCT ID: NCT00659789

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

HIV I Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vacc-4x

Intervention Type: DRUG

Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

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.

Group Type: PLACEBO_COMPARATOR

Sterile water

Intervention Type: DRUG

Sterile water is used in place of Vacc-4x and in place of Leukine

Interventions

Vacc-4x

Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

Intervention Type: DRUG

Sterile water

Sterile water is used in place of Vacc-4x and in place of Leukine

Intervention Type: DRUG

Other Intervention Names

Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13.; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bionor Immuno AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Pollard, MD

Role: PRINCIPAL_INVESTIGATOR

University of California at Davis, USA

Jürgen Rochstroh, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Bonn, Germany

Locations

UCLA CARE Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

UC Davis Medical Center

Sacramento, California, United States

University of Miami School of Medicine

Miami, Florida, United States

Northwestern University Division of Infectious Diseases

Chicago, Illinois, United States

EPIMED GmbH

Berlin, State of Berlin, Germany

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Universitätsklinikum Bonn

Bonn, , Germany

Klinik I für Innere Medizin Klinikum Der Universität zu Köln

Cologne, , Germany

ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George

Hamburg, , Germany

Universitätsklinikum Hamburg Eppendorf

Hamburg, , Germany

Istituto San Raffaele

Milan, , Italy

Hospital Germans Trias i Pujol

Badalona, , Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat.

Barcelona, , Spain

Brighton and Sussex University Hospital, HIV/GUM Research, Elton John Centre

Brighton, , United Kingdom

Chelsea and Westminster Hospital

London, , United Kingdom

Harrison Wing St Thomas' Hospital

London, , United Kingdom

Countries

United States; Germany; Italy; Spain; United Kingdom

References

Pollard RB, Rockstroh JK, Pantaleo G, Asmuth DM, Peters B, Lazzarin A, Garcia F, Ellefsen K, Podzamczer D, van Lunzen J, Arasteh K, Schurmann D, Clotet B, Hardy WD, Mitsuyasu R, Moyle G, Plettenberg A, Fisher M, Fatkenheuer G, Fischl M, Taiwo B, Baksaas I, Jolliffe D, Persson S, Jelmert O, Hovden AO, Sommerfelt MA, Wendel-Hansen V, Sorensen 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. Epub 2014 Feb 11.

Reference Type: DERIVED

PMID: 24525316 (View on PubMed)

Other Identifiers

2007-006302-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13619

Identifier Type: OTHER

Identifier Source: secondary_id

CT-BI Vacc-4x 2007/1

Identifier Type: -

Identifier Source: org_study_id