Trial Outcomes & Findings for Re-boosting of HIV-1 Infected Subjects With Vacc-4x (NCT NCT01712256)
NCT ID: NCT01712256
Last Updated: 2017-03-06
Results Overview
Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
37 weeks
Results posted on
2017-03-06
Participant Flow
Participant milestones
| Measure |
Re-boosting With Vacc-4x
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.
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|---|---|
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Overall Study
STARTED
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33
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Overall Study
COMPLETED
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32
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Re-boosting With Vacc-4x
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.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Re-boosting With Vacc-4x
n=33 Participants
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.
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|---|---|
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Age, Continuous
|
47.0 years
STANDARD_DEVIATION 7.12 • n=33 Participants
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Gender
Female
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6 Participants
n=33 Participants
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Gender
Male
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27 Participants
n=33 Participants
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Region of Enrollment
United States
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8 participants
n=33 Participants
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Region of Enrollment
United Kingdom
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3 participants
n=33 Participants
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Region of Enrollment
Italy
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2 participants
n=33 Participants
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Region of Enrollment
Germany
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10 participants
n=33 Participants
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Region of Enrollment
Spain
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10 participants
n=33 Participants
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BMI
|
25.64 kg/m^2
STANDARD_DEVIATION 5.077 • n=33 Participants
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Time since HIV diagnosis
|
5786.8 Days
STANDARD_DEVIATION 2043.44 • n=33 Participants
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Total time on ART
|
138.6 months
STANDARD_DEVIATION 57.42 • n=33 Participants
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Currently on ART
|
30 participants
n=33 Participants
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Pre-ART HIV-1 viral load
|
67502.4 copies/mL
STANDARD_DEVIATION 150008.65 • n=27 Participants • 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.
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PRIMARY outcome
Timeframe: 37 weeksPopulation: 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).
Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.
Outcome measures
| Measure |
Re-boosting With Vacc-4x
n=30 Participants
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.
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|---|---|
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Vacc-4x Effect on Viral Load Set-point
CT Vacc-4x 2012/1 VL set point, ITT
|
38455.0 Copies/mL
Standard Deviation 46628.69
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Vacc-4x Effect on Viral Load Set-point
CT Vacc-4x 2012/1 VL set point, PP
|
40088.8 Copies/mL
Standard Deviation 48923.00
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Vacc-4x Effect on Viral Load Set-point
CT-BI Vacc-4x 2007/1 VL Set Point, ITT
|
45253.9 Copies/mL
Standard Deviation 55676.68
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Vacc-4x Effect on Viral Load Set-point
CT-BI Vacc-4x 2007/1 VL Set Point, PP
|
47336.8 Copies/mL
Standard Deviation 58031.65
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SECONDARY outcome
Timeframe: 36 weeksPopulation: 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.
Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1
Outcome measures
| Measure |
Re-boosting With Vacc-4x
n=30 Participants
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.
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|---|---|
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Baseline; ITT
|
782.21 cells/micro liter
Standard Deviation 278.303
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Baseline, PP
|
795.74 cells/micro liter
Standard Deviation 283.990
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 2, ITT
|
764.8 cells/micro liter
Standard Deviation 245.79
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 2, PP
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778.1 cells/micro liter
Standard Deviation 731.0
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 4, ITT
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791.1 cells/micro liter
Standard Deviation 321.53
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 4, PP
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805.6 cells/micro liter
Standard Deviation 328.31
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 12, ITT
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772.2 cells/micro liter
Standard Deviation 324.2
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 12, PP
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789.4 cells/micro liter
Standard Deviation 326.96
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 16, ITT
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705.2 cells/micro liter
Standard Deviation 233.36
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 16, PP
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718.1 cells/micro liter
Standard Deviation 235.41
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 20, ITT
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574.9 cells/micro liter
Standard Deviation 185.81
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 20, PP
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581.2 cells/micro liter
Standard Deviation 191.63
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 24, ITT
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544.0 cells/micro liter
Standard Deviation 144.60
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 24, PP
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557.9 cells/micro liter
Standard Deviation 142.98
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 28, ITT
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534.2 cells/micro liter
Standard Deviation 140.16
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 28, PP
|
542.5 cells/micro liter
Standard Deviation 145.70
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 36, ITT
|
579.0 cells/micro liter
Standard Deviation 59.57
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Vacc-4x Effect on Immune Response Measured as CD4 Count
Week 36, PP
|
579.0 cells/micro liter
Standard Deviation 59.57
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SECONDARY outcome
Timeframe: 36 weeksPopulation: 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.
Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1
Outcome measures
| Measure |
Re-boosting With Vacc-4x
n=30 Participants
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.
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|---|---|
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 20, ITT
|
1282.1 cells/micro liter
Standard Deviation 633.71
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 20, PP
|
1257.8 cells/micro liter
Standard Deviation 649.42
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 24, ITT
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1430.9 cells/micro liter
Standard Deviation 588.85
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Baseline; ITT
|
979.43 cells/micro liter
Standard Deviation 352.891
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Baseline, PP
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972.19 cells/micro liter
Standard Deviation 364.810
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 2, ITT
|
988.7 cells/micro liter
Standard Deviation 315.63
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 2, PP
|
971.4 cells/micro liter
Standard Deviation 320.59
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 4, ITT
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926.3 cells/micro liter
Standard Deviation 361.44
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 4, PP
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919.0 cells/micro liter
Standard Deviation 369.43
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 12, ITT
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952.0 cells/micro liter
Standard Deviation 451.76
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 12, PP
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954.0 cells/micro liter
Standard Deviation 455.80
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 16, ITT
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962.6 cells/micro liter
Standard Deviation 307.56
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 16, PP
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966.9 cells/micro liter
Standard Deviation 311.06
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 24, PP
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1444.6 cells/micro liter
Standard Deviation 609.71
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 28, ITT
|
1261.9 cells/micro liter
Standard Deviation 511.76
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 28, PP
|
1245.1 cells/micro liter
Standard Deviation 536.84
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 36, ITT
|
1230.7 cells/micro liter
Standard Deviation 192.25
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Vacc-4x Effect on Immune Response Measured as CD8 Count
Week 36, PP
|
1302.7 cells/micro liter
Standard Deviation 192.25
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SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.
Outcome measures
| Measure |
Re-boosting With Vacc-4x
n=30 Participants
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.
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|---|---|
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Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration
Week 0, ITT
|
10 participants
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Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration
Week 0, PP
|
9 participants
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Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration
Week 4, ITT
|
20 participants
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Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration
Week 4, PP
|
19 participants
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: 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.
The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.
Outcome measures
| Measure |
Re-boosting With Vacc-4x
n=30 Participants
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.
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|---|---|
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Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema
Week 0, ITT
|
19 participants
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Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema
Week 0, PP
|
17 participants
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Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema
Week 4, ITT
|
19 participants
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Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema
Week 4, PP
|
18 participants
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SECONDARY outcome
Timeframe: 37 weeksTo evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events
Outcome measures
| Measure |
Re-boosting With Vacc-4x
n=33 Participants
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.
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|---|---|
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Number of Participants With Adverse Events as a Measure of Safety and Tolerability
With any TEAE
|
31 participants
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Number of Participants With Adverse Events as a Measure of Safety and Tolerability
With injection site reaction
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19 participants
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Number of Participants With Adverse Events as a Measure of Safety and Tolerability
With any TESAE
|
2 participants
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Number of Participants With Adverse Events as a Measure of Safety and Tolerability
With any AE leading to discontinuation
|
0 participants
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Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Deaths
|
0 participants
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Adverse Events
Re-boosting With Vacc-4x
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Re-boosting With Vacc-4x
n=33 participants at risk
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.
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|---|---|
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Infections and infestations
HIV infection
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
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Vascular disorders
Haemorrhage
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
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Other adverse events
| Measure |
Re-boosting With Vacc-4x
n=33 participants at risk
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.
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|---|---|
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General disorders
Application site pruritus
|
48.5%
16/33 • Number of events 21 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
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General disorders
Injection site pruritus
|
39.4%
13/33 • Number of events 17 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
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General disorders
Fatigue
|
21.2%
7/33 • Number of events 8 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
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General disorders
Influenza-like illness
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
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General disorders
Injection site erythema
|
12.1%
4/33 • Number of events 6 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
General disorders
Asthenia
|
9.1%
3/33 • Number of events 4 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
General disorders
Application site reaction
|
6.1%
2/33 • Number of events 5 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
General disorders
Injection site Vesicles
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Infections and infestations
Oral candidiasis
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Infections and infestations
Bronchitis
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
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|
Infections and infestations
Gastroenteritis
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremities
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
3/33 • Number of events 4 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Nervous system disorders
Headache
|
18.2%
6/33 • Number of events 6 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Nervous system disorders
Paraesthesia
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
3/33 • Number of events 5 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
18.2%
6/33 • Number of events 10 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Gastrointestinal disorders
diarrhoea
|
9.1%
3/33 • Number of events 4 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
|
|
Vascular disorders
Hypertension
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER