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Re-boosting of HIV-1 Infected Subjects With Vacc-4x (Re-boost)

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ClinicalTrials.gov Identifier: NCT01712256
Recruitment Status : Completed
First Posted : October 23, 2012
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Bionor Immuno AS

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Intervention Biological: Vacc-4x
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Re-boosting With Vacc-4x
Hide Arm/Group Description

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.

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

Period Title: Overall Study
Started 33
Completed 32
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Re-boosting With Vacc-4x
Hide Arm/Group Description

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.

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

Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
47.0  (7.12)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
6
  18.2%
Male
27
  81.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
8
United Kingdom Number Analyzed 33 participants
3
Italy Number Analyzed 33 participants
2
Germany Number Analyzed 33 participants
10
Spain Number Analyzed 33 participants
10
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 33 participants
25.64  (5.077)
Time since HIV diagnosis  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 33 participants
5786.8  (2043.44)
Total time on ART  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 33 participants
138.6  (57.42)
Currently on ART  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
30
Pre-ART HIV-1 viral load   [1] 
Mean (Standard Deviation)
Unit of measure:  copies/mL
Number Analyzed 27 participants
67502.4  (150008.65)
[1]
Measure Analysis Population Description: Examination of the data suggest that the CRF question was interpreted in different ways with respect to stopping and starting ART, and changing the composition of the ART received and the answers given cannot be relied upon.
1.Primary Outcome
Title Vacc-4x Effect on Viral Load Set-point
Hide Description Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.
Time Frame 37 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
In the ITT population there were 20 evaluable subjects out of 30 (3 subjects did not receive ART from Screening through Week 12) and in the PP population there were 18 evaluable subjects out of 27 (an additional 3 subjects did not discontinue ART at Week 12).
Arm/Group Title Re-boosting With Vacc-4x
Hide Arm/Group Description:

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.

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

Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Copies/mL
CT Vacc-4x 2012/1 VL set point, ITT Number Analyzed 20 participants
38455.0  (46628.69)
CT Vacc-4x 2012/1 VL set point, PP Number Analyzed 18 participants
40088.8  (48923.00)
CT-BI Vacc-4x 2007/1 VL Set Point, ITT Number Analyzed 22 participants
45253.9  (55676.68)
CT-BI Vacc-4x 2007/1 VL Set Point, PP Number Analyzed 20 participants
47336.8  (58031.65)
2.Secondary Outcome
Title Vacc-4x Effect on Immune Response Measured as CD4 Count
Hide Description Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).

Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.

Arm/Group Title Re-boosting With Vacc-4x
Hide Arm/Group Description:

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.

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

Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: cells/micro liter
Baseline; ITT Number Analyzed 29 participants
782.21  (278.303)
Baseline, PP Number Analyzed 27 participants
795.74  (283.990)
Week 2, ITT Number Analyzed 29 participants
764.8  (245.79)
Week 2, PP Number Analyzed 27 participants
778.1  (731.0)
Week 4, ITT Number Analyzed 29 participants
791.1  (321.53)
Week 4, PP Number Analyzed 27 participants
805.6  (328.31)
Week 12, ITT Number Analyzed 29 participants
772.2  (324.2)
Week 12, PP Number Analyzed 27 participants
789.4  (326.96)
Week 16, ITT Number Analyzed 27 participants
705.2  (233.36)
Week 16, PP Number Analyzed 25 participants
718.1  (235.41)
Week 20, ITT Number Analyzed 27 participants
574.9  (185.81)
Week 20, PP Number Analyzed 25 participants
581.2  (191.63)
Week 24, ITT Number Analyzed 23 participants
544.0  (144.60)
Week 24, PP Number Analyzed 21 participants
557.9  (142.98)
Week 28, ITT Number Analyzed 20 participants
534.2  (140.16)
Week 28, PP Number Analyzed 18 participants
542.5  (145.70)
Week 36, ITT Number Analyzed 3 participants
579.0  (59.57)
Week 36, PP Number Analyzed 3 participants
579.0  (59.57)
3.Secondary Outcome
Title Vacc-4x Effect on Immune Response Measured as CD8 Count
Hide Description Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).

Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.

Arm/Group Title Re-boosting With Vacc-4x
Hide Arm/Group Description:

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.

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

Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: cells/micro liter
Baseline; ITT Number Analyzed 29 participants
979.43  (352.891)
Baseline, PP Number Analyzed 27 participants
972.19  (364.810)
Week 2, ITT Number Analyzed 29 participants
988.7  (315.63)
Week 2, PP Number Analyzed 27 participants
971.4  (320.59)
Week 4, ITT Number Analyzed 29 participants
926.3  (361.44)
Week 4, PP Number Analyzed 27 participants
919.0  (369.43)
Week 12, ITT Number Analyzed 29 participants
952.0  (451.76)
Week 12, PP Number Analyzed 27 participants
954.0  (455.80)
Week 16, ITT Number Analyzed 27 participants
962.6  (307.56)
Week 16, PP Number Analyzed 25 participants
966.9  (311.06)
Week 20, ITT Number Analyzed 27 participants
1282.1  (633.71)
Week 20, PP Number Analyzed 25 participants
1257.8  (649.42)
Week 24, ITT Number Analyzed 23 participants
1430.9  (588.85)
Week 24, PP Number Analyzed 21 participants
1444.6  (609.71)
Week 28, ITT Number Analyzed 20 participants
1261.9  (511.76)
Week 28, PP Number Analyzed 18 participants
1245.1  (536.84)
Week 36, ITT Number Analyzed 3 participants
1230.7  (192.25)
Week 36, PP Number Analyzed 3 participants
1302.7  (192.25)
4.Secondary Outcome
Title Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration
Hide Description The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).

Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.

Arm/Group Title Re-boosting With Vacc-4x
Hide Arm/Group Description:

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.

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

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
Week 0, ITT Number Analyzed 30 participants
10
Week 0, PP Number Analyzed 27 participants
9
Week 4, ITT Number Analyzed 30 participants
20
Week 4, PP Number Analyzed 27 participants
19
5.Secondary Outcome
Title Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema
Hide Description The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).

Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.

Arm/Group Title Re-boosting With Vacc-4x
Hide Arm/Group Description:

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.

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

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
Week 0, ITT Number Analyzed 30 participants
19
Week 0, PP Number Analyzed 27 participants
17
Week 4, ITT Number Analyzed 30 participants
19
Week 4, PP Number Analyzed 27 participants
18
6.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description To evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events
Time Frame 37 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Re-boosting With Vacc-4x
Hide Arm/Group Description:

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.

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

Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
With any TEAE 31
With injection site reaction 19
With any TESAE 2
With any AE leading to discontinuation 0
Deaths 0
Time Frame Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Re-boosting With Vacc-4x
Hide Arm/Group Description

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.

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

All-Cause Mortality
Re-boosting With Vacc-4x
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Re-boosting With Vacc-4x
Affected / at Risk (%) # Events
Total   2/33 (6.06%)    
Infections and infestations   
HIV infection  1  1/33 (3.03%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Oropharyngeal cancer stage unspecified  1  1/33 (3.03%)  1
Vascular disorders   
Haemorrhage  1  1/33 (3.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Re-boosting With Vacc-4x
Affected / at Risk (%) # Events
Total   31/33 (93.94%)    
Blood and lymphatic system disorders   
Lymphadenopathy  1  6/33 (18.18%)  10
Gastrointestinal disorders   
diarrhoea  1  3/33 (9.09%)  4
Nausea  1  3/33 (9.09%)  3
Aphthous stomatitis  1  2/33 (6.06%)  3
General disorders   
Application site pruritus  1  16/33 (48.48%)  21
Injection site pruritus  1  13/33 (39.39%)  17
Fatigue  1  7/33 (21.21%)  8
Influenza-like illness  1  4/33 (12.12%)  4
Injection site erythema  1  4/33 (12.12%)  6
Asthenia  1  3/33 (9.09%)  4
Application site reaction  1  2/33 (6.06%)  5
Injection site Vesicles  1  2/33 (6.06%)  3
Infections and infestations   
Oral candidiasis  1  4/33 (12.12%)  4
Bronchitis  1  2/33 (6.06%)  2
Gastroenteritis  1  2/33 (6.06%)  2
Nasopharyngitis  1  2/33 (6.06%)  2
Upper respiratory tract infection  1  2/33 (6.06%)  2
Injury, poisoning and procedural complications   
Contusion  1  2/33 (6.06%)  3
Musculoskeletal and connective tissue disorders   
Pain in extremities  1  4/33 (12.12%)  4
Arthralgia  1  3/33 (9.09%)  4
Myalgia  1  3/33 (9.09%)  3
Nervous system disorders   
Headache  1  6/33 (18.18%)  6
Paraesthesia  1  2/33 (6.06%)  2
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  4/33 (12.12%)  4
Night sweats  1  3/33 (9.09%)  5
Vascular disorders   
Hypertension  1  2/33 (6.06%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maja Sommerfelt
Organization: Bionor Pharma ASA
Phone: +4723010960
EMail: ms@bionorpharma.com
Layout table for additonal information
Responsible Party: Bionor Immuno AS
ClinicalTrials.gov Identifier: NCT01712256     History of Changes
Other Study ID Numbers: CT-BI Vacc-4x 2012/1
First Submitted: October 16, 2012
First Posted: October 23, 2012
Results First Submitted: January 11, 2017
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017