Re-boosting of HIV-1 Infected Subjects With Vacc-4x
Re-boost
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
1 other identifier
interventional
33
5 countries
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2012
Shorter than P25 for phase_2
10 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
October 16, 2012
CompletedFirst Posted
Study publicly available on registry
October 23, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
March 6, 2017
CompletedMarch 6, 2017
January 1, 2017
1.1 years
October 16, 2012
January 11, 2017
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vacc-4x Effect on Viral Load Set-point
Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.
37 weeks
Secondary Outcomes (5)
Vacc-4x Effect on Immune Response Measured as CD4 Count
36 weeks
Vacc-4x Effect on Immune Response Measured as CD8 Count
36 weeks
Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration
4 weeks
Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema
4 Weeks
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
37 weeks
Study Arms (1)
Re-boosting with Vacc-4x
EXPERIMENTALIntradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
Interventions
Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
Eligibility Criteria
You may qualify if:
- 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).
- Documented pre-study CD4 cell count ≥400x106/L.
- Documented pre-study viral load \< 300 000copies/mL.
- Signed informed consent.
You may not qualify if:
- Reported AIDS-defining illness within the previous year.
- Malignant disease.
- On chronic treatment with immune-suppressive therapy.
- 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.
- Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis.
- Pregnant or breastfeeding women.
- 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.
- Current participation in other clinical therapeutic studies.
- Incapability of compliance to treatment protocol, in the opinion of the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bionor Immuno ASlead
Study Sites (10)
UCLA CARE Center
Los Angeles, California, 90035, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I; Immunologische Ambulanz, Siegmund-Freud-Str. 25
Bonn, Bonn, 53127, Germany
ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George
Hamburg, Hamburg, 20099, Germany
EIPMED - Gesellschaft fűr epidemiologische und klinische Forschung in der Medizin mbH Rubensstrasse 125
Berlin, State of Berlin, 12157, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Istituto San Raffaele
Milan, Milano, 20127, Italy
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat.
Barcelona, 08907, Spain
Harrison Wing St Thomas' Hospital
London, London, SE1 7EH, United Kingdom
Related Publications (5)
Kran AM, Sommerfelt MA, Baksaas I, Sorensen 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: 22339677BACKGROUNDLind A, Sommerfelt M, Holmberg JO, Baksaas I, Sorensen 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. doi: 10.3109/00365548.2011.653581. Epub 2012 Feb 19.
PMID: 22339485BACKGROUNDJones 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: 20721838BACKGROUNDKran AM, Sorensen 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. doi: 10.1097/01.aids.0000210620.75707.ac.
PMID: 16470131BACKGROUNDRockstroh JK, Asmuth D, Pantaleo G, Clotet B, Podzamczer D, van Lunzen J, Arasteh K, Mitsuyasu R, Peters B, Silvia N, Jolliffe D, Okvist M, Krogsgaard K, Sommerfelt MA. Re-boost immunizations with the peptide-based therapeutic HIV vaccine, Vacc-4x, restores geometric mean viral load set-point during treatment interruption. PLoS One. 2019 Jan 30;14(1):e0210965. doi: 10.1371/journal.pone.0210965. eCollection 2019.
PMID: 30699178DERIVED
MeSH Terms
Conditions
Interventions
Results Point of Contact
- Title
- Maja Sommerfelt
- Organization
- Bionor Pharma ASA
Study Officials
- STUDY DIRECTOR
Vidar Wendel-Hansen, Dr. med
Bionor Pharma ASA, Kronprinsesse Märthas Plass 1, P.O. Box 1477 Vika, NO-0116 Oslo, Norway
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2012
First Posted
October 23, 2012
Study Start
December 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
March 6, 2017
Results First Posted
March 6, 2017
Record last verified: 2017-01
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.