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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006302-13 | EudraCT Number | ||
| 13619 | Other Identifier | FDA IND |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacc-4x | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacc-4x | Drug | Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | 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. | Up to week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Pollard, MD | University of California at Davis, USA | Principal Investigator |
| Jürgen Rochstroh, MD | Universitätsklinikum Bonn, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA CARE Center | Los Angeles | California | 90035 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24525316 | Derived | 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. |
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Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.
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137 study participants were enrolled. One participant withdrew prior to randomization.
The first subject was screened on 29 July 2008 and the first immunization was given on 22 August 2008. The last subject completed the study (to Week 52) on 22 June 2010. The last long-term follow-up visit was 07 June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18. |
| FG001 | Placebo Injections (Group II) While on ART |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sterile water | Drug | Sterile water is used in place of Vacc-4x and in place of Leukine |
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| Immunogenicity | Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema | Week 1, week 18 and week 52 |
| Effect of Vacc-4x on CD8 Counts | CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52 | Weeks 6,18,24,28,32,36,40,44,48,52. |
| Time to Restart of ART for Vacc-4x Subjects Versus Placebo | Kaplan-Meier Estimate of Time to restart ART (from time coming off ART) | Between Week 28 to Week 52 |
| Effects on Vacc-4x on HIV-1 RNA | Weeks 24,28,32,36,40,44,48,52. |
| 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 |
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18. |
| COMPLETED |
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| NOT COMPLETED |
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ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18. |
| BG001 | Placebo Injections (Group II) While on ART | Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Gender | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Height | Median | Full Range | cm |
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| Time since HIV diagnosis (days) | Median | Full Range | days |
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| CD4 nadir | Median | Full Range | 10^6 cells/L |
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| Pre-ART CD4 | Median | Full Range | 10^6 cells/L |
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| Pre-ART HIV-1 viral load | Median | Full Range | copies/mL |
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| Total time on ART | Median | Full Range | months |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. | ITT Population | Posted | Number | participants | From Week 28 to Week 52 |
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| Secondary | Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths | 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. | Safety Population | Posted | Number | participants | Up to week 52 |
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| Secondary | Immunogenicity | Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema | ITT Population | Posted | Number | participants | Week 1, week 18 and week 52 |
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| Secondary | Effect of Vacc-4x on CD8 Counts | CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52 | Subject who stopped ART at week 28 and remained off ART until week 52 | Posted | Median | Inter-Quartile Range | cells/µL | Weeks 6,18,24,28,32,36,40,44,48,52. |
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| Secondary | Time to Restart of ART for Vacc-4x Subjects Versus Placebo | Kaplan-Meier Estimate of Time to restart ART (from time coming off ART) | ITT Population | Posted | Mean | Standard Deviation | days | Between Week 28 to Week 52 |
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| Secondary | Effects on Vacc-4x on HIV-1 RNA | Posted | Mean | Standard Deviation | copies/mL | Weeks 24,28,32,36,40,44,48,52. |
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Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART | Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18. | 4 | 93 | 91 | 93 | ||
| EG001 | Placebo Injections (Group II) While on ART | Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18. | 3 | 42 | 40 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis perforated | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment | Perforated appendix |
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| Multiple sclerosis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment | Multiple sclerosis |
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| Cellulitis of male external genital organ | Infections and infestations | MedDRA 11.1 | Systematic Assessment | Cellulitis of scrotum and penis |
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| Appendicitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment | Acute appendicitis resulting in appendectomy |
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| Postoperative wound infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment | Surgical wound infection |
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| Necrosis | General disorders | MedDRA 11.1 | Systematic Assessment | Atypic(al) necrosis of both femoral heads |
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| Bipolar disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment | Bipolar disorder resulting in hospitalization |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment | Prolonged anesthesia effects (dizziness) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 11.1 | Systematic Assessment | Injection site erythema |
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| Injection site induration | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Influenza-like illness | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| ALT increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| AST increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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The Sponsor (or designee) will prepare a final report on the study. The Investigator may not publish or present any information on this study without the express written approval of the Sponsor. Additionally, the Sponsor, may, for any reason, withhold approval for publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maja Sommerfelt | Bionor Pharma ASA | +4723010960 | ms@bionorpharma.com |
| ID | Term |
|---|---|
| C494182 | Vacc-4x |
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| >=55 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Subjects not qualifying for ART interruption |
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| Subjects resuming ART between week 28 and 52 |
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| Subjects restarting ART at Week 52/termination |
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