Trial Outcomes & Findings for Clinical Trial of HIV Vaccine Combinations in Healthy Men and Women (NCT NCT03408262)
NCT ID: NCT03408262
Last Updated: 2024-10-16
Results Overview
Number of participants with mucosal (semen, nasal, vaginal or rectal) binding IgG antibodies to HIV CN54gp140 antigen, as determined by ELISA
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
At two weeks after the final immunisation
Results posted on
2024-10-16
Participant Flow
Participant milestones
| Measure |
Group A
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group B
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group C
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group D
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group E
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group F
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group G
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group H
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
6
|
6
|
13
|
6
|
6
|
9
|
7
|
|
Overall Study
COMPLETED
|
11
|
6
|
6
|
12
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
0
|
1
|
0
|
0
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of HIV Vaccine Combinations in Healthy Men and Women
Baseline characteristics by cohort
| Measure |
Group A
n=15 Participants
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group B
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group C
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group D
n=13 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group E
n=6 Participants
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group F
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group G
n=9 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group H
n=7 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
68 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
39 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White British
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White Irish
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Any other white background
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Indian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Pakistani
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Bangladeshi
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Any other Asian background
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Mixed White and Black Caribbean
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Mixed White and Black African
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Mixed White and Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Any other Mixed background
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black Caribbean
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black African
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Any other Black background
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
13 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=10 Participants
|
9 participants
n=115 Participants
|
7 participants
n=24 Participants
|
68 participants
n=42 Participants
|
|
Number of participants with CN54-gp140 IgG antibodies at time of vaccination
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: At two weeks after the final immunisationNumber of participants with mucosal (semen, nasal, vaginal or rectal) binding IgG antibodies to HIV CN54gp140 antigen, as determined by ELISA
Outcome measures
| Measure |
Group A
n=11 Participants
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group B
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group C
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group D
n=12 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group E
n=6 Participants
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group F
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group G
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group H
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mucosal Binding IgG Antibodies to HIV CN54gp140 Antigen
|
0 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to twenty-four weeks after the final immunisationNumber of Participants With Severe or Greater (Grades 3-4) Adverse Reactions up to twenty-four weeks after the final immunisation
Outcome measures
| Measure |
Group A
n=15 Participants
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group B
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group C
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group D
n=13 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group E
n=6 Participants
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group F
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group G
n=9 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group H
n=7 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Severe or Greater (Grades 3-4) Adverse Reactions During the Study
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: At two weeks after the final immunisationPopulation: Serum from participants at two weeks after the final immunisation
Median concentration of CN54-gp140 specific IgG binding antibodies, as measured by ELISA. Concentration is in ng/mL
Outcome measures
| Measure |
Group A
n=7 Participants
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group B
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group C
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group D
n=9 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group E
n=6 Participants
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group F
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group G
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group H
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
|---|---|---|---|---|---|---|---|---|
|
Median Concentration of CN54-gp140 Specific IgG Binding Antibodies
|
464 ng/mL
Interval 23.0 to 1521.0
|
14141 ng/mL
Interval 3971.0 to 18348.0
|
8992 ng/mL
Interval 3798.0 to 79435.0
|
11367 ng/mL
Interval 398.0 to 26149.0
|
6280 ng/mL
Interval 1102.0 to 15044.0
|
9639 ng/mL
Interval 3250.0 to 14282.0
|
20512 ng/mL
Interval 10583.0 to 36552.0
|
9041 ng/mL
Interval 4735.0 to 21023.0
|
SECONDARY outcome
Timeframe: At two weeks post-final immunisationNumber of participants with detectable serum binding antibodies to HIV CN54gp140 antigen, as measured by IgG binding ELISA
Outcome measures
| Measure |
Group A
n=11 Participants
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group B
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group C
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group D
n=12 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group E
n=6 Participants
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group F
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group G
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group H
n=6 Participants
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Detectable Serum Binding Antibodies to HIV CN54gp140 Antigen
|
7 Participants
|
6 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
Adverse Events
Group A
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group C
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group E
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group F
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group G
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group H
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=12 participants at risk
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group B
n=6 participants at risk
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group C
n=6 participants at risk
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group D
n=12 participants at risk
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group E
n=6 participants at risk
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group F
n=6 participants at risk
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group G
n=6 participants at risk
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group H
n=6 participants at risk
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Depressive Disorder Triggering Overdose
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Renal and urinary disorders
UTI on Kidney stones
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Gastrointestinal disorders
Haematemesis secondary to Mallory Weiss
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Concussion
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Skin and subcutaneous tissue disorders
Cellulitis on hand
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
Other adverse events
| Measure |
Group A
n=12 participants at risk
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group B
n=6 participants at risk
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group C
n=6 participants at risk
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group D
n=12 participants at risk
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group E
n=6 participants at risk
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group F
n=6 participants at risk
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group G
n=6 participants at risk
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
Group H
n=6 participants at risk
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 2 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea/nasopharyngitis/rhinitis/cold/upper respiratory tract infection
|
33.3%
4/12 • Number of events 8 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
33.3%
2/6 • Number of events 2 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
33.3%
2/6 • Number of events 4 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
33.3%
4/12 • Number of events 4 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 2 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
50.0%
3/6 • Number of events 4 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Road traffic accident
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
33.3%
2/6 • Number of events 2 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Myalgia
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Product Issues
Tenderness left arm
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 7 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Skin and subcutaneous tissue disorders
Fungal skin infection
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 3 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Dizziness
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 2 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Headache
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 2 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 3 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 2 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 2 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Surgical and medical procedures
Right wrist synovialcyst surgical removal
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Pyrexia
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Social circumstances
Sports injury
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Infections and infestations
Influenza like illness
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Musculoskeletal and connective tissue disorders
Lateral femoral nerve compression
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Vomiting, vision blurred, headache and fatigue
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 2 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Social circumstances
Hangover/Alcoholic Withdrawal Symptoms
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Toothache
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 2 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Feverish
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Ear and labyrinth disorders
Eye pruritis
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Dygeusia
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
1/6 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Reproductive system and breast disorders
Testicular pain
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Eye disorders
Conjunctivitis
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Oropharyngeal discomfort
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
General disorders
Fatigue
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
16.7%
2/12 • Number of events 3 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Musculoskeletal and connective tissue disorders
Biceps tendon tenderness
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Renal and urinary disorders
Cystitis
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Musculoskeletal and connective tissue disorders
shoulder/clavicle region tenderness
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Infections and infestations
lower respiratory tract infection
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
|
Infections and infestations
Threadworm infection
|
8.3%
1/12 • Number of events 1 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/12 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
0.00%
0/6 • 12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place