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
3 other identifiers
interventional
137
5 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2008
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2008
CompletedFirst Posted
Study publicly available on registry
April 16, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
January 5, 2017
CompletedFebruary 23, 2017
November 1, 2016
1.8 years
April 14, 2008
July 22, 2015
January 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
From Week 28 to Week 52
Secondary Outcomes (5)
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Up to week 52
Immunogenicity
Week 1, week 18 and week 52
Effect of Vacc-4x on CD8 Counts
Weeks 6,18,24,28,32,36,40,44,48,52.
Time to Restart of ART for Vacc-4x Subjects Versus Placebo
Between Week 28 to Week 52
Effects on Vacc-4x on HIV-1 RNA
Weeks 24,28,32,36,40,44,48,52.
Study Arms (2)
Vacc-4x
EXPERIMENTALVacc-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.
Placebo
PLACEBO COMPARATORPlacebo 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.
Interventions
Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
Sterile water is used in place of Vacc-4x and in place of Leukine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bionor Immuno ASlead
Study Sites (18)
UCLA CARE Center
Los Angeles, California, 90035, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048-8700, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Northwestern University Division of Infectious Diseases
Chicago, Illinois, 60611, United States
EPIMED GmbH
Berlin, State of Berlin, 12157, Germany
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 13353, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Klinik I für Innere Medizin Klinikum Der Universität zu Köln
Cologne, 50937, Germany
ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George
Hamburg, 20099, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Istituto San Raffaele
Milan, Italy
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Clinic i Provincial
Barcelona, 08036, Spain
Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat.
Barcelona, 08907, Spain
Brighton and Sussex University Hospital, HIV/GUM Research, Elton John Centre
Brighton, BN2 1EE, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Harrison Wing St Thomas' Hospital
London, United Kingdom
Related Publications (1)
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.
PMID: 24525316DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Maja Sommerfelt
- Organization
- Bionor Pharma ASA
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Pollard, MD
University of California at Davis, USA
- PRINCIPAL INVESTIGATOR
Jürgen Rochstroh, MD
Universitätsklinikum Bonn, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2008
First Posted
April 16, 2008
Study Start
August 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2011
Last Updated
February 23, 2017
Results First Posted
January 5, 2017
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share
Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.