Trial Outcomes & Findings for iHIVARNA Clinical Trial in HIV Infected Individuals (NCT NCT02888756)
NCT ID: NCT02888756
Last Updated: 2019-12-23
Results Overview
* Grade 3 or above local adverse event (pain, cutaneous reactions including induration). * Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia). * Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively. Any event attributable to vaccination leading to discontinuation of the immunisation regimen.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
week 6
Results posted on
2019-12-23
Participant Flow
Participant milestones
| Measure |
iHIVARNA-01
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Vaccination Period
STARTED
|
16
|
9
|
8
|
|
Vaccination Period
COMPLETED
|
16
|
9
|
8
|
|
Vaccination Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Analytical Treatment Interruption
STARTED
|
15
|
9
|
8
|
|
Analytical Treatment Interruption
COMPLETED
|
5
|
3
|
3
|
|
Analytical Treatment Interruption
NOT COMPLETED
|
10
|
6
|
5
|
Reasons for withdrawal
| Measure |
iHIVARNA-01
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Analytical Treatment Interruption
Physician Decision
|
10
|
6
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
iHIVARNA-01
n=16 Participants
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 Participants
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=8 Participants
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants
|
9 Participants
n=9 Participants
|
8 Participants
n=8 Participants
|
33 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=33 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=16 Participants
|
9 Participants
n=9 Participants
|
8 Participants
n=8 Participants
|
32 Participants
n=33 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
1 participants
n=16 Participants
|
1 participants
n=9 Participants
|
0 participants
n=8 Participants
|
2 participants
n=33 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=16 Participants
|
3 participants
n=9 Participants
|
3 participants
n=8 Participants
|
12 participants
n=33 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=16 Participants
|
5 participants
n=9 Participants
|
5 participants
n=8 Participants
|
19 participants
n=33 Participants
|
|
CD4 T cell counts
|
793 cells/microliter
n=16 Participants
|
708 cells/microliter
n=9 Participants
|
742 cells/microliter
n=8 Participants
|
769 cells/microliter
n=33 Participants
|
PRIMARY outcome
Timeframe: week 6* Grade 3 or above local adverse event (pain, cutaneous reactions including induration). * Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia). * Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively. Any event attributable to vaccination leading to discontinuation of the immunisation regimen.
Outcome measures
| Measure |
iHIVARNA-01
n=16 Participants
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 Participants
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=8 Participants
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: week 6 and week 18Change from baseline immunogenicity as measured by ELISPOT at week 6 and 18, i.e. two weeks and 14 weeks after the last immunization compared to both control groups
Outcome measures
| Measure |
iHIVARNA-01
n=16 Participants
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 Participants
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=8 Participants
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Immunogenicity as Measured by Elispot
week 6
|
-0.07 delta log difference spot forming units
Interval -0.35 to 0.2
|
0.18 delta log difference spot forming units
Interval -0.17 to 0.52
|
0.01 delta log difference spot forming units
Interval -0.57 to 0.6
|
|
Immunogenicity as Measured by Elispot
week 18
|
-0.08 delta log difference spot forming units
Interval -0.57 to 0.42
|
-0.12 delta log difference spot forming units
Interval -0.61 to 0.36
|
0.45 delta log difference spot forming units
Interval -0.52 to 1.42
|
SECONDARY outcome
Timeframe: week 10, 18 and 30Population: The data were not collected. In the protocol it was pre-specified, that ICS would not be done if Elispot results did not show immunogenicity of the study product. This analysis was not performed, because the results from the Elispot assay at the same time points showed no increase in the number of spot-forming units, also see primary outcome two.
HIV-specific CD4+ and CD8+ T cell responses after immunization by the number of poly-functional T cells as determined by intracellular cytokine staining, (ICS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 6-18Population: One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial.
time until viral rebound (defined as two consecutive measurements of plasma viral load \> 1000 copies/mL separated by at least 15 days) after discontinuation at week 6.
Outcome measures
| Measure |
iHIVARNA-01
n=15 Participants
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 Participants
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=8 Participants
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Time to Viral Rebound
|
50 days
Interval 33.0 to 57.0
|
55.5 days
Interval 43.0 to 77.0
|
58 days
Interval 36.0 to 72.0
|
SECONDARY outcome
Timeframe: week 6-18Population: One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial.
difference in log10 copies/ml plasma viral load in vivo after analytical treatment interruption (ATI, week 6-restart ART), compared to placebo WFI
Outcome measures
| Measure |
iHIVARNA-01
n=15 Participants
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 Participants
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=8 Participants
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Change in Plasma Viral Load
|
-0.17 log10 copies/ml
Interval -1.1 to 0.77
|
-0.14 log10 copies/ml
Interval -1.18 to 0.9
|
1.26 log10 copies/ml
Interval 0.21 to 2.31
|
SECONDARY outcome
Timeframe: week 18Population: One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial.
proportion of patients with viral load below detectable level of 50 copies/mL in plasma after ATI, week 18
Outcome measures
| Measure |
iHIVARNA-01
n=15 Participants
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 Participants
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=8 Participants
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Functional Cure
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from baseline to week 6Change in frequency of at least 0.7log10 HIV-specific T-cell responses between baseline and week 6
Outcome measures
| Measure |
iHIVARNA-01
n=13 Participants
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=7 Participants
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=6 Participants
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Primary Immune Response Against Vaccine
|
0.01 delta log spot forming units
Interval -0.56 to 0.57
|
0.17 delta log spot forming units
Interval -0.47 to 0.81
|
2.65 delta log spot forming units
Interval 1.94 to 3.37
|
SECONDARY outcome
Timeframe: week 4The capacity of CD8 T cells to suppress virus production in HIV infected autologous CD4 T cells, after vaccination. For this purpose PBMC are isolated and separated in CD8 and CD4 T cells. CD4 cells are infected with HIV. Thereafter CD4 cells are co-cultured with pre-stimulated CD8 cells and the capacity to suppress virus production at different effector to target (E:T) ratios is measured, by the change of p24 Gag production. Pannus et al AIDS 2019, PMID: 30702513
Outcome measures
| Measure |
iHIVARNA-01
n=10 Participants
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 Participants
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=5 Participants
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
CD8 T Cell Mediated Viral Suppression
stimulated (E:T) 2:1
|
0.15 log(pg/ml)
Interval -0.69 to 0.99
|
0.22 log(pg/ml)
Interval -0.73 to 1.16
|
0.18 log(pg/ml)
Interval -0.48 to 0.85
|
|
CD8 T Cell Mediated Viral Suppression
Stimulated (E:T) 0.1:1
|
-0.65 log(pg/ml)
Interval -1.26 to -0.05
|
-1.32 log(pg/ml)
Interval -2.0 to -0.65
|
0.41 log(pg/ml)
Interval -0.08 to 0.9
|
SECONDARY outcome
Timeframe: day 0-90 (week 4, week 4 + 1 day and week 5 and week 6) and day 90-130 (week 18) and day >130 (week 30)effect on reservoir as measured by changes in the proviral DNA copy numbers per million cells during and after immunization
Outcome measures
| Measure |
iHIVARNA-01
n=16 Participants
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 Participants
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=8 Participants
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Proviral DNA Reservoir
proviral DNA 0-90 days
|
-0.002 delta log copies DNA /10E6 cel
Interval -0.007 to 0.003
|
-0.001 delta log copies DNA /10E6 cel
Interval -0.007 to 0.004
|
0.007 delta log copies DNA /10E6 cel
Interval 0.003 to 0.011
|
|
Proviral DNA Reservoir
proviral DNA 90-130 days
|
0.004 delta log copies DNA /10E6 cel
Interval -0.01 to 0.019
|
0.004 delta log copies DNA /10E6 cel
Interval -0.013 to 0.02
|
-0.003 delta log copies DNA /10E6 cel
Interval -0.015 to 0.008
|
|
Proviral DNA Reservoir
proviral DNA >130 days
|
-0.001 delta log copies DNA /10E6 cel
Interval -0.007 to 0.005
|
-0.002 delta log copies DNA /10E6 cel
Interval -0.01 to 0.006
|
-0.003 delta log copies DNA /10E6 cel
Interval -0.007 to 0.002
|
SECONDARY outcome
Timeframe: week 18Population: data were not collected
viral immune escape: change in % mutated epitopes from pre-cART to post-ATI
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 6 and 18Population: data were not collected
host protein mRNA expression profiles in whole blood
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 0-30 (week 4, week 4 + 1 day and week 5) and day 30-80 (week 6), 80-150 days (week 18) and >150 days (week 30)effect on reservoir as measured by changes in the intracellular viral RNA copy numbers per million cells during and after immunization
Outcome measures
| Measure |
iHIVARNA-01
n=16 Participants
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 Participants
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=8 Participants
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Cell-associated RNA Viral Reservoir
caRNA 0-30 days
|
-0.001 delta log copies RNA/ml
Interval -0.009 to 0.007
|
-0.002 delta log copies RNA/ml
Interval -0.012 to 0.008
|
-0.004 delta log copies RNA/ml
Interval -0.011 to 0.003
|
|
Cell-associated RNA Viral Reservoir
caRNA 30-80 days
|
-0.006 delta log copies RNA/ml
Interval -0.015 to 0.003
|
-0.001 delta log copies RNA/ml
Interval -0.014 to 0.01
|
0.032 delta log copies RNA/ml
Interval 0.024 to 0.04
|
|
Cell-associated RNA Viral Reservoir
caRNA 80-150 days
|
0.002 delta log copies RNA/ml
Interval -0.008 to 0.012
|
0.003 delta log copies RNA/ml
Interval -0.008 to 0.015
|
-0.016 delta log copies RNA/ml
Interval -0.024 to -0.008
|
|
Cell-associated RNA Viral Reservoir
caRNA >150 days
|
0.002 delta log copies RNA/ml
Interval -0.008 to 0.011
|
-0.001 delta log copies RNA/ml
Interval -0.012 to 0.01
|
-0.004 delta log copies RNA/ml
Interval -0.011 to 0.003
|
Adverse Events
iHIVARNA-01
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
TriMix
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
iHIVARNA-01
n=16 participants at risk
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 participants at risk
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=8 participants at risk
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Gastrointestinal disorders
Colitis
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
Other adverse events
| Measure |
iHIVARNA-01
n=16 participants at risk
Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval
iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption
TriMix: Therapeutic vaccination, followed by treatment interruption
|
TriMix
n=9 participants at risk
Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval
TriMix: Therapeutic vaccination, followed by treatment interruption
|
Placebo
n=8 participants at risk
Water for injection 3 vaccinations, two weeks interval
Placebo: Therapeutic vaccination, followed by treatment interruption
|
|---|---|---|---|
|
Vascular disorders
hypotensions
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Immune system disorders
Hypersensitivity
|
6.2%
1/16 • Number of events 3 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
General disorders
Asthenia
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
General disorders
Chills
|
12.5%
2/16 • Number of events 2 • 30 weeks
|
11.1%
1/9 • Number of events 2 • 30 weeks
|
12.5%
1/8 • Number of events 2 • 30 weeks
|
|
General disorders
Cyst
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
General disorders
Fatigue
|
12.5%
2/16 • Number of events 3 • 30 weeks
|
33.3%
3/9 • Number of events 5 • 30 weeks
|
25.0%
2/8 • Number of events 4 • 30 weeks
|
|
General disorders
influenza-like illness
|
6.2%
1/16 • Number of events 2 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
General disorders
Infusion site extravasation
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
12.5%
1/8 • Number of events 2 • 30 weeks
|
|
General disorders
Injection site pain
|
18.8%
3/16 • Number of events 3 • 30 weeks
|
22.2%
2/9 • Number of events 3 • 30 weeks
|
25.0%
2/8 • Number of events 4 • 30 weeks
|
|
General disorders
Injection site puritis
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 2 • 30 weeks
|
|
General disorders
Injection site reaction
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
General disorders
Malaise
|
18.8%
3/16 • Number of events 6 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
12.5%
1/8 • Number of events 2 • 30 weeks
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
General disorders
Tenderness
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
General disorders
Urethritis
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Psychiatric disorders
Burn-out syndrome
|
0.00%
0/16 • 30 weeks
|
22.2%
2/9 • Number of events 2 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Psychiatric disorders
Mental disoreder
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Psychiatric disorders
Nightmare
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Reproductive system and breast disorders
Balanoposthitis
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Injury, poisoning and procedural complications
wrist fracture
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Investigations
Blood creatine-phospho kinase increased
|
12.5%
2/16 • Number of events 2 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 2 • 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Nervous system disorders
Aphasia
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 2 • 30 weeks
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 2 • 30 weeks
|
|
Nervous system disorders
Headache
|
37.5%
6/16 • Number of events 7 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
50.0%
4/8 • Number of events 8 • 30 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 2 • 30 weeks
|
|
Nervous system disorders
Muscle contractions involuntary
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Nervous system disorders
Neuralgia
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Nervous system disorders
Somnolence
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Eye disorders
Vitreous floaters
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Gastrointestinal disorders
Aphthous ulcer
|
6.2%
1/16 • Number of events 2 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
44.4%
4/9 • Number of events 4 • 30 weeks
|
25.0%
2/8 • Number of events 2 • 30 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Gastrointestinal disorders
Entercolitis
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
25.0%
2/8 • Number of events 3 • 30 weeks
|
|
Gastrointestinal disorders
Esophageal pain
|
12.5%
2/16 • Number of events 2 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Erythemia
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
11.1%
1/9 • Number of events 2 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Althragia
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscles spasms
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.2%
5/16 • Number of events 6 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
25.0%
2/8 • Number of events 5 • 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Metabolism and nutrition disorders
Gout
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.2%
1/16 • Number of events 2 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Furunkel
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Gastro enteritis
|
12.5%
2/16 • Number of events 2 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Gingivitis
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Hepatitis viral
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Infections and infestations
Laryngitis
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Infections and infestations
Lung infection
|
0.00%
0/16 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
|
Infections and infestations
Oral herpes
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Respiratory tract infection
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Sexually transmitted disease
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • Number of events 1 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 2 • 30 weeks
|
|
Infections and infestations
Tonsillitis
|
6.2%
1/16 • Number of events 2 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
2/16 • Number of events 2 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • 30 weeks
|
11.1%
1/9 • Number of events 1 • 30 weeks
|
0.00%
0/8 • 30 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
25.0%
4/16 • Number of events 5 • 30 weeks
|
0.00%
0/9 • 30 weeks
|
12.5%
1/8 • Number of events 1 • 30 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60