Trial Outcomes & Findings for First-In-Human Study of ChAdOx1-HBV & MVA-HBV Vaccines (VTP-300) for Chronic HBV (NCT NCT04778904)
NCT ID: NCT04778904
Last Updated: 2024-08-13
Results Overview
The incidence of TEAEs and and ≥Grade 3 study vaccine-related adverse events will be based on the number and percentage of participants with events and number of events. TEAEs are defined as all adverse events occurring after study vaccine administration; they will be further categorised by Seriousness, Severity (i.e. ≥ Grade 3) and Causality. Seriousness of the TEAEs is assessed according to the published FDA criteria (2016). Severity of the TEAEs will be graded according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adults and Volunteers Enrolled in Preventative Vaccine Trials, 2007 (70 FR 22664).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
From each study vaccination for the following 27 days
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Group 1 (MVA-HBV)
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
18
|
18
|
9
|
|
Overall Study
COMPLETED
|
9
|
18
|
17
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1 (MVA-HBV)
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
First-In-Human Study of ChAdOx1-HBV & MVA-HBV Vaccines (VTP-300) for Chronic HBV
Baseline characteristics by cohort
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Total
n=55 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
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
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
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
South Korea
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
4 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Region of Enrollment
Taiwan
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
30 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From each study vaccination for the following 27 daysPopulation: Safety analysis set - all participants who received at least one vaccination.
The incidence of TEAEs and and ≥Grade 3 study vaccine-related adverse events will be based on the number and percentage of participants with events and number of events. TEAEs are defined as all adverse events occurring after study vaccine administration; they will be further categorised by Seriousness, Severity (i.e. ≥ Grade 3) and Causality. Seriousness of the TEAEs is assessed according to the published FDA criteria (2016). Severity of the TEAEs will be graded according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adults and Volunteers Enrolled in Preventative Vaccine Trials, 2007 (70 FR 22664).
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination
Incidence of vaccine related adverse events following vaccination · Participants experiencing events
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination
Incidence of vaccine related adverse events following vaccination · No events
|
9 Participants
|
17 Participants
|
16 Participants
|
8 Participants
|
|
The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination
Grade 3 or greater vaccine related adverse events following vaccination · Participants experiencing events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination
Grade 3 or greater vaccine related adverse events following vaccination · No events
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination
Serious Adverse Events vaccine related following vaccination · Participants experiencing events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination
Serious Adverse Events vaccine related following vaccination · No events
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From each study vaccination with nivolumab for the following 27 daysPopulation: All participants who received at least one vaccination and nivolumab.
The incidence of ≥Grade 3 adverse events will be based on the number and percentage of participants with events and number of events. TEAEs are defined as all adverse events occurring after study vaccine administration with nivolumab; they are further categorised by Seriousness, Severity (i.e. ≥ Grade 3) according to FDA Guidance 70 FR 22664 and Causality.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab
Participants experiencing events
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab
No events
|
10 Participants
|
18 Participants
|
17 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From study admission (the signature of informed consent) to the end of the study (Month 9)Population: Safety analysis set - all participants who received at least one vaccination
The incidence of AESIs will be based on the number and percentage of participants with events and number of events. AESIs specific to this study include pneumonitis, grade 3 or 4 diarrhoea, diabetes, thyroid diseases, colitis, nephritis, immune-related endocrinopathies, myocarditis, immune-related skin conditions, or other unspecified immune-related adverse reactions.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
The Incidence of Participants With Adverse Events of Special Interest (AESIs)
Participants with Adverse Events of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
The Incidence of Participants With Adverse Events of Special Interest (AESIs)
Participants with no AESI
|
10 Participants
|
18 Participants
|
16 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From each study vaccination for the following 27 daysThe incidence of TEAEs will be based on the number and proportion of participants with events and number of events and will be calculated for each of the four study groups.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group
No events
|
4 Participants
|
10 Participants
|
7 Participants
|
5 Participants
|
|
The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group
Participants experiencing events
|
6 Participants
|
8 Participants
|
11 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From the first vaccination until Month 9 (end of study)Population: Safety analysis set - participants who received at least one vaccination
The incidence of participants will be based upon the number and proportion of patients in each treatment group with clinically significant laboratory signs (haematology and biochemistry, including liver function tests) as assessed by the investigator. All laboratory signs will be reported in SI units. If any laboratory sign is considered to be clinically significant i.e. outside laboratory normal reference range, the severity of this sign will be assessed according to the FDA Guidance for Industry 70 FR 22664. Absolute change, change from baseline and worst change for each participant will be calculated. The incidence of participants with treatment-emergent, clinically significant laboratory signs and laboratory signs of Grade 3-4 severity will be calculated for each treatment group at each time point.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator
Haematology · Clinically Significant
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator
Haematology · Non Clinically Significant
|
10 Participants
|
18 Participants
|
16 Participants
|
9 Participants
|
|
Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator
Biochemistry · Clinically Significant
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator
Biochemistry · Non Clinically Significant
|
10 Participants
|
18 Participants
|
17 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From the first vaccination until Month 9 (end of study)Population: Safety Analysis Set - participants who received at least one vaccination
The incidence of participants will be based upon the number and proportion of patients in each treatment group with clinically significant vital signs. Vital signs will be considered to be potentially clinically significant if they respectively fall below or above the relevant upper and lower limits. The incidence of participants with treatment-emergent, clinically significant vital signs will be calculated for each treatment group at each time point.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator
Pulse Rate · Clinically Significant
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator
Pulse Rate · Non Clinically Significant
|
10 Participants
|
18 Participants
|
17 Participants
|
9 Participants
|
|
Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator
Blood Pressure · Clinically Significant
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator
Blood Pressure · Non Clinically Significant
|
9 Participants
|
15 Participants
|
15 Participants
|
7 Participants
|
|
Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator
Temperature · Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator
Temperature · Non Clinically Significant
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From baseline till Month 9Population: Statistical Analysis Plan changed analysis of laboratory results so that shift tables of laboratory results, vital signs, and physical examinations were summarised using the worst post-baseline result overall, rather than by time point as indicated in the protocol.
Hematology laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA). For all hematology parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study. The number of participants showing shifts of at least two severity grades (as worst change from baseline for each hematology parameter) will be presented within shift tables.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Prothrombin time · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
WBC decrease · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
WBC decrease · Participants with no change
|
10 Participants
|
18 Participants
|
17 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
WBC increase · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
WBC increase · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
8 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Eosinophils · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Eosinophils · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Lymphocytes Decrease · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Lymphocytes Decrease · Participants with no change
|
10 Participants
|
18 Participants
|
17 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Neutrophils Decrease · Participants with at least two severity grades change
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Neutrophils Decrease · Participants with no change
|
9 Participants
|
18 Participants
|
16 Participants
|
8 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Haemoglobin · Participants with at least two severity grades change
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Haemoglobin · Participants with no change
|
9 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Platelets decrease · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Platelets decrease · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters
Prothrombin time · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline till Month 9Population: Statistical analysis Plan has changed the planned analysis so that shift tables of laboratory results were summarised using the worst post-baseline result overall, rather than by time point as indicated in the protocol.
Biochemistry laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA). For all biochemistry parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study. The number of participants showing shifts of at least two severity grades (as worst change from baseline for each biochemistry parameter) will be presented within shift tables.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Creatinine · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Alanine Aminotransferase · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Alanine Aminotransferase · Participants with no change
|
10 Participants
|
18 Participants
|
16 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Aspartate Aminotransferase · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Aspartate Aminotransferase · Participants with no change
|
10 Participants
|
18 Participants
|
17 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Alkaline Phosphatase · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Alkaline Phosphatase · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Bilirubin Increase · Participants with at least two severity grades change
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Bilirubin Increase · Participants with no change
|
10 Participants
|
17 Participants
|
17 Participants
|
8 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Blood Urea Nitrogen · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Blood Urea Nitrogen · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Creatinine · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Hypokalemia · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Hypokalemia · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Hyperkalemia · Participants with at least two severity grades change
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Hyperkalemia · Participants with no change
|
10 Participants
|
17 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Hyponatremia · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Hyponatremia · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Hypernatremia · Participants with at least two severity grades change
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Hypernatremia · Participants with no change
|
10 Participants
|
17 Participants
|
17 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Hypoalbuminemia · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters
Hypoalbuminemia · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From baseline till Month 9Population: Statistical Analysis Plan changed planned analysis so that shift tables of laboratory results, vital signs, and physical examinations were summarised using the worst post-baseline result overall, rather than by time point as indicated in the protocol.
Worst change is defined as the lowest and highest post-baseline values for heart rate (bradycardia, tachycardia) and systolic blood pressure (hypotension, hypertension), and as the highest post-baseline values for diastolic blood pressure (hypertension) and temperature (fever). For all vital signs measurements, changes from baseline will be calculated for each timepoint at which the vital sign measurement is conducted throughout the study. The number of participants showing worst change from baseline for the vital signs parameters overall will be presented within shift tables.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Hypertension (Systolic) · Participants with no change
|
9 Participants
|
16 Participants
|
17 Participants
|
8 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Bradycardia · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Bradycardia · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
7 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Tachycardia · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Tachycardia · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Hypotension · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Hypotension · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Hypertension (Systolic) · Participants with at least two severity grades change
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Hypertension (diastolic) · Participants with at least two severity grades change
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Hypertension (diastolic) · Participants with no change
|
8 Participants
|
15 Participants
|
17 Participants
|
8 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Fever · Participants with at least two severity grades change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)
Fever · Participants with no change
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9Population: Immunogenicity Analysis Set
The frequency of HBV-specific CD4+ and CD8+ T cells was determined by stimulating Peripheral Blood Mononuclear Cells (PBMC) with peptide pools corresponding to HBV antigens Core, Polymerase and Surface in an Intracellular Cytokine Staining (ICS) flow cytometry assay. In this assay the percentage of CD4+ or CD8+ expressing cytokines IFNγ, IL-2 or TNFα in response to HBV peptides is measured. Frequencies of antigen-specific cytokine-expressing CD4+ or CD8+ T cells are compared across trial timepoints and treatment groups.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=9 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=17 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=17 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 3 (Pol 1+2)
|
0.0068 percentage of cells
Interval -0.003 to 0.0463
|
0.0000 percentage of cells
Interval -0.0091 to 0.0178
|
0.0002 percentage of cells
Interval 0.0 to 0.0222
|
-0.0149 percentage of cells
Interval -0.1094 to 0.0485
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 3 (Pol 3+4)
|
0.0109 percentage of cells
Interval -0.1014 to 0.0492
|
0.0007 percentage of cells
Interval -0.0098 to 0.0174
|
0.0120 percentage of cells
Interval -0.0257 to 0.0369
|
-0.0232 percentage of cells
Interval -0.0869 to 0.1094
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 35 (Pol 3+4)
|
0.0052 percentage of cells
Interval -0.1305 to 0.0688
|
0.0093 percentage of cells
Interval -0.0283 to 0.0341
|
0.0000 percentage of cells
Interval -0.0098 to 0.0303
|
-0.0191 percentage of cells
Interval -0.0562 to 0.0412
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 6 (Pol 1+2)
|
0.0058 percentage of cells
Interval 0.0 to 0.1146
|
0.0009 percentage of cells
Interval 0.0 to 0.0304
|
0.0000 percentage of cells
Interval -0.0047 to 0.0275
|
-0.0085 percentage of cells
Interval -0.1068 to 0.0058
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 6 (Pol 3+4)
|
0.0066 percentage of cells
Interval -0.1055 to 0.0395
|
0.0022 percentage of cells
Interval -0.0183 to 0.0653
|
-0.0034 percentage of cells
Interval -0.0194 to 0.0575
|
-0.0232 percentage of cells
Interval -0.0611 to 0.1405
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 9 (Pol 3+4)
|
0.0058 percentage of cells
Interval -0.0767 to 0.0243
|
0.0069 percentage of cells
Interval -0.0143 to 0.0453
|
0.0154 percentage of cells
Interval -0.0489 to 0.027
|
-0.0267 percentage of cells
Interval -0.0419 to 0.0247
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 7 (Pre-S1/S2+S)
|
0.0071 percentage of cells
Interval -0.0249 to 0.0441
|
-0.0372 percentage of cells
Interval -0.0862 to 0.0177
|
-0.0173 percentage of cells
Interval -0.055 to 0.0163
|
-0.0117 percentage of cells
Interval -0.0954 to 0.03
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 28 (Pre-S1/S2+S)
|
0.0022 percentage of cells
Interval -0.0484 to 0.0929
|
0.0058 percentage of cells
Interval -0.0203 to 0.0148
|
-0.0210 percentage of cells
Interval -0.0679 to 0.0088
|
-0.0304 percentage of cells
Interval -0.0627 to 0.0057
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 35 (Pre-S1/S2+S)
|
-0.0162 percentage of cells
Interval -0.0727 to 0.0478
|
0.0031 percentage of cells
Interval -0.0318 to 0.0705
|
-0.0363 percentage of cells
Interval -0.0639 to 0.0244
|
-0.0260 percentage of cells
Interval -0.0724 to 1.3927
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 3 (Pre-S1/S2+S)
|
-0.0166 percentage of cells
Interval -0.0332 to 0.0329
|
0.0005 percentage of cells
Interval -0.0252 to 0.0269
|
-0.0319 percentage of cells
Interval -0.0824 to 0.0373
|
0.0158 percentage of cells
Interval -0.1124 to 0.0621
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 6 (Pre-S1/S2+S)
|
0.0107 percentage of cells
Interval -0.0318 to 0.0575
|
-0.0119 percentage of cells
Interval -0.0556 to 0.0393
|
-0.0202 percentage of cells
Interval -0.0869 to 0.0428
|
-0.0215 percentage of cells
Interval -0.0396 to 0.0866
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 9 (Pre-S1/S2+S)
|
0.0052 percentage of cells
Interval -0.0188 to 0.0347
|
-0.0011 percentage of cells
Interval -0.0384 to 0.0512
|
-0.0249 percentage of cells
Interval -0.1262 to 0.021
|
-0.0270 percentage of cells
Interval -0.0364 to 0.0233
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 7 (Core)
|
0.0027 percentage of cells
Interval -0.0556 to 0.0975
|
0.0000 percentage of cells
Interval -0.0353 to 0.0262
|
-0.0010 percentage of cells
Interval -0.0357 to 0.0573
|
-0.0231 percentage of cells
Interval -0.0853 to 0.1737
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 28 (Core)
|
0.0054 percentage of cells
Interval -0.0421 to 0.1203
|
0.0000 percentage of cells
Interval -0.0575 to 0.0098
|
-0.0203 percentage of cells
Interval -0.0553 to 0.0245
|
-0.0011 percentage of cells
Interval -0.0182 to 0.0412
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 35 (Core)
|
-0.0194 percentage of cells
Interval -0.0442 to 0.0299
|
0.0003 percentage of cells
Interval -0.0078 to 0.0815
|
0.0000 percentage of cells
Interval -0.0455 to 0.0285
|
0.0000 percentage of cells
Interval -0.0496 to 0.1169
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 3 (Core)
|
-0.0364 percentage of cells
Interval -0.1506 to 0.028
|
0.0147 percentage of cells
Interval -0.0208 to 0.0617
|
-0.0204 percentage of cells
Interval -0.0553 to 0.0081
|
0.0008 percentage of cells
Interval -0.0804 to 0.0334
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 6 (Core)
|
0.0108 percentage of cells
Interval -0.1378 to 0.0819
|
0.0145 percentage of cells
Interval -0.0119 to 0.0578
|
-0.0219 percentage of cells
Interval -0.0568 to 0.0097
|
-0.0061 percentage of cells
Interval -0.0737 to 0.1041
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 9 (Core)
|
0.0000 percentage of cells
Interval -0.1506 to 0.0467
|
0.0092 percentage of cells
Interval -0.0033 to 0.0951
|
0.0038 percentage of cells
Interval -0.0215 to 0.0341
|
-0.0001 percentage of cells
Interval -0.044 to 0.0724
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 7 (Pol 1+2)
|
0.0000 percentage of cells
Interval -0.0131 to 0.0662
|
0.0000 percentage of cells
Interval 0.0 to 0.0
|
0.0000 percentage of cells
Interval -0.0179 to 0.0621
|
-0.0018 percentage of cells
Interval -0.1589 to 0.0481
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 28 (Pol 1+2)
|
0.0000 percentage of cells
Interval -0.0131 to 0.0265
|
0.0000 percentage of cells
Interval -0.0286 to 0.006
|
0.0000 percentage of cells
Interval -0.0004 to 0.0267
|
-0.0276 percentage of cells
Interval -0.1589 to 0.0
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 35 (Pol 1+2)
|
0.0000 percentage of cells
Interval -0.015 to 0.0
|
0.0000 percentage of cells
Interval 0.0 to 0.037
|
0.0010 percentage of cells
Interval -0.0102 to 0.0345
|
-0.0401 percentage of cells
Interval -0.7508 to 0.0135
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 3 (Pol 1+2)
|
0.0146 percentage of cells
Interval -0.015 to 0.1076
|
0.0018 percentage of cells
Interval 0.0 to 0.0446
|
0.0000 percentage of cells
Interval 0.0 to 0.0025
|
0.0000 percentage of cells
Interval -0.1354 to 0.0196
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 9 (Pol 1+2)
|
0.0000 percentage of cells
Interval -0.0075 to 0.0802
|
0.0054 percentage of cells
Interval 0.0 to 0.0404
|
0.0000 percentage of cells
Interval -0.0085 to 0.0288
|
-0.0152 percentage of cells
Interval -0.1589 to 0.0044
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 7 (Pol 3+4)
|
0.0189 percentage of cells
Interval -0.0345 to 0.1001
|
-0.0055 percentage of cells
Interval -0.0415 to 0.0098
|
0.0322 percentage of cells
Interval -0.0213 to 0.1084
|
-0.0443 percentage of cells
Interval -0.145 to 0.0363
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 7 (Core)
|
0.0034 percentage of cells
Interval -0.0277 to 0.0625
|
-0.0131 percentage of cells
Interval -0.0382 to 0.005
|
0.0050 percentage of cells
Interval -0.0344 to 0.0181
|
-0.0016 percentage of cells
Interval -0.0178 to 0.0092
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 28 (Core)
|
-0.0089 percentage of cells
Interval -0.0511 to 0.0294
|
0.0050 percentage of cells
Interval -0.0215 to 0.0338
|
-0.0003 percentage of cells
Interval -0.0303 to 0.0081
|
-0.0051 percentage of cells
Interval -0.0496 to 0.1999
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 35 (Core)
|
-0.0165 percentage of cells
Interval -0.0551 to 0.0336
|
-0.0009 percentage of cells
Interval -0.0081 to 0.0208
|
-0.0003 percentage of cells
Interval -0.0294 to 0.0182
|
-0.0024 percentage of cells
Interval -0.0602 to 0.0818
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 3 (Core)
|
-0.0099 percentage of cells
Interval -0.0551 to 0.0228
|
0.0058 percentage of cells
Interval -0.0098 to 0.0113
|
0.0051 percentage of cells
Interval -0.0437 to 0.0272
|
-0.0142 percentage of cells
Interval -0.0796 to 0.1142
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 28 (Pol 3+4)
|
-0.0075 percentage of cells
Interval -0.0523 to 0.1291
|
0.0051 percentage of cells
Interval -0.0271 to 0.0647
|
0.0004 percentage of cells
Interval -0.0358 to 0.0579
|
-0.0161 percentage of cells
Interval -0.1284 to 0.0796
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 6 (Core)
|
0.0128 percentage of cells
Interval -0.0406 to 0.0312
|
-0.0163 percentage of cells
Interval -0.0313 to -0.0017
|
-0.0213 percentage of cells
Interval -0.0403 to 0.0066
|
0.0197 percentage of cells
Interval -0.1181 to 0.1317
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 35 (Pol 3+4)
|
-0.0021 percentage of cells
Interval -0.0754 to 0.0883
|
0.0131 percentage of cells
Interval -0.0043 to 0.1186
|
0.0477 percentage of cells
Interval 0.0006 to 0.1503
|
0.0144 percentage of cells
Interval -0.2188 to 0.5461
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 9 (Core)
|
0.0068 percentage of cells
Interval -0.0247 to 0.0334
|
-0.0033 percentage of cells
Interval -0.0174 to 0.0363
|
-0.0107 percentage of cells
Interval -0.0262 to 0.02
|
-0.0260 percentage of cells
Interval -0.0378 to 0.0177
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 7 (Pol 1+2)
|
0.0068 percentage of cells
Interval -0.003 to 0.0315
|
-0.0040 percentage of cells
Interval -0.0139 to 0.0
|
0.0020 percentage of cells
Interval 0.0 to 0.0399
|
-0.0162 percentage of cells
Interval -0.1309 to 0.0072
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 3 (Pol 3+4)
|
0.0375 percentage of cells
Interval -0.0235 to 0.0757
|
0.0180 percentage of cells
Interval -0.0228 to 0.2331
|
0.0110 percentage of cells
Interval -0.0318 to 0.0749
|
-0.0430 percentage of cells
Interval -0.2208 to 0.1043
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 28 (Pol 1+2)
|
0.0063 percentage of cells
Interval -0.003 to 0.0245
|
0.0000 percentage of cells
Interval -0.0097 to 0.0016
|
0.0000 percentage of cells
Interval 0.0 to 0.0077
|
-0.0155 percentage of cells
Interval -0.1436 to 0.0193
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 6 (Pol 3+4)
|
0.0318 percentage of cells
Interval -0.0373 to 0.1127
|
0.0096 percentage of cells
Interval -0.0267 to 0.098
|
0.0138 percentage of cells
Interval -0.0042 to 0.1727
|
-0.0585 percentage of cells
Interval -0.2379 to 0.112
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 35 (Pol 1+2)
|
0.0046 percentage of cells
Interval -0.0018 to 0.0153
|
0.0025 percentage of cells
Interval -0.0097 to 0.0386
|
0.0000 percentage of cells
Interval 0.0 to 0.0153
|
-0.0162 percentage of cells
Interval -0.3456 to 0.0201
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 9 (Pol 3+4)
|
0.0478 percentage of cells
Interval -0.0746 to 0.2997
|
0.0068 percentage of cells
Interval -0.0329 to 0.0804
|
0.0412 percentage of cells
Interval -0.0138 to 0.0888
|
-0.0634 percentage of cells
Interval -0.0906 to 0.2202
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 6 (Pol 1+2)
|
0.0235 percentage of cells
Interval -0.0008 to 0.0567
|
0.0000 percentage of cells
Interval -0.0097 to 0.0067
|
0.0000 percentage of cells
Interval -0.0118 to 0.017
|
-0.0196 percentage of cells
Interval -0.105 to 0.0555
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Month 9 (Pol 1+2)
|
0.0066 percentage of cells
Interval -0.0062 to 0.1149
|
-0.0011 percentage of cells
Interval -0.0101 to 0.0147
|
0.0000 percentage of cells
Interval 0.0 to 0.011
|
-0.0155 percentage of cells
Interval -0.1639 to 0.0054
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 7 (Pol 3+4)
|
0.0152 percentage of cells
Interval -0.0838 to 0.0737
|
-0.0035 percentage of cells
Interval -0.0436 to 0.0204
|
-0.0023 percentage of cells
Interval -0.0166 to 0.0188
|
-0.0218 percentage of cells
Interval -0.0579 to 0.0266
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD4+ Change from Baseline to Day 28 (Pol 3+4)
|
-0.0076 percentage of cells
Interval -0.0258 to 0.0827
|
0.0028 percentage of cells
Interval -0.0291 to 0.0191
|
0.0000 percentage of cells
Interval -0.0261 to 0.0126
|
-0.0324 percentage of cells
Interval -0.0729 to 0.0493
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 7 (Pre-S1/S2+S)
|
0.0054 percentage of cells
Interval -0.0262 to 0.1085
|
0.0042 percentage of cells
Interval -0.0301 to 0.0525
|
-0.0034 percentage of cells
Interval -0.0491 to 0.1314
|
-0.0574 percentage of cells
Interval -0.1699 to 0.1008
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 28 (Pre-S1/S2+S)
|
0.0000 percentage of cells
Interval -0.0774 to 0.0462
|
0.0065 percentage of cells
Interval -0.0871 to 0.0304
|
-0.0130 percentage of cells
Interval -0.1008 to 0.0711
|
-0.0120 percentage of cells
Interval -0.1582 to 0.099
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Day 35 (Pre-S1/S2+S)
|
-0.0093 percentage of cells
Interval -0.2066 to 0.0
|
0.0000 percentage of cells
Interval -0.0265 to 0.0999
|
0.0000 percentage of cells
Interval -0.0484 to 0.0651
|
-0.0446 percentage of cells
Interval -0.1609 to 0.7839
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 3 (Pre-S1/S2+S)
|
-0.0304 percentage of cells
Interval -0.0881 to 0.0524
|
0.0385 percentage of cells
Interval 0.0 to 0.1025
|
-0.0292 percentage of cells
Interval -0.0802 to 0.0
|
-0.0390 percentage of cells
Interval -0.2847 to 0.1337
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 6 (Pre-S1/S2+S)
|
0.0481 percentage of cells
Interval -0.2066 to 0.1186
|
0.0000 percentage of cells
Interval -0.065 to 0.0267
|
0.0215 percentage of cells
Interval -0.0376 to 0.0713
|
-0.0246 percentage of cells
Interval -0.1491 to 0.1077
|
|
Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen
CD8+ Change from Baseline to Month 9 (Pre-S1/S2+S)
|
0.0012 percentage of cells
Interval 0.0 to 0.0897
|
0.0195 percentage of cells
Interval -0.0221 to 0.1407
|
-0.0130 percentage of cells
Interval -0.1505 to 0.1012
|
0.0006 percentage of cells
Interval -0.1844 to 0.1839
|
SECONDARY outcome
Timeframe: Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9Population: Per Protocol population used for HBsAg changes
This will be determined from samples of PBMCs. The percentage of participants with a HBsAg loss \>0.5 log10 and \>1.0 log10 will be determined for each vaccine and for each treatment group.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Day 7 · > 0.5 log10
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Day 7 · > 1.0 log10
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Day 7 · No log change or <0.5 log10
|
10 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Day 28 · > 0.5 log10
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Day 28 · > 1.0 log10
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Day 28 · No log change or <0.5 log10
|
9 Participants
|
17 Participants
|
18 Participants
|
9 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Day 35 · > 0.5 log10
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Day 35 · > 1.0 log10
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Day 35 · No log change or <0.5 log10
|
9 Participants
|
18 Participants
|
18 Participants
|
9 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Month 3 · > 0.5 log10
|
0 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Month 3 · > 1.0 log10
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Month 3 · No log change or <0.5 log10
|
9 Participants
|
14 Participants
|
7 Participants
|
8 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Month 6 · > 0.5 log10
|
1 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Month 6 · > 1.0 log10
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Month 6 · No log change or <0.5 log10
|
8 Participants
|
13 Participants
|
10 Participants
|
9 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Month 9 · > 0.5 log10
|
1 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Month 9 · > 1.0 log10
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction in HBsAg Titre
Loss from Baseline to Month 9 · No log change or <0.5 log10
|
8 Participants
|
14 Participants
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 9Population: Intent to Treat Analysis Set
The proportion of participants infected with HBsAg-positive virus at baseline who develop Hepatitis B surface antigen antibody will be determined for each vaccine and for each treatment group. The proportion of participants infected with HBeAg-positive virus at baseline who develop Hepatitis B e-antigen antibody will be determined for each vaccine and for each treatment group.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Percentage of Participants With HBsAg and HBeAg Loss
HBsAg Seroconversion at Month 9 · Seroconversion
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Percentage of Participants With HBsAg and HBeAg Loss
HBsAg Seroconversion at Month 9 · No Seroconversion
|
9 Participants
|
18 Participants
|
15 Participants
|
9 Participants
|
|
Percentage of Participants With HBsAg and HBeAg Loss
HBeAg Seroconversion1 at Month 9 · Seroconversion
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Percentage of Participants With HBsAg and HBeAg Loss
HBeAg Seroconversion1 at Month 9 · No Seroconversion
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: ITT Analysis Set
The proportion of participants infected with HBsAg-positive virus at baseline who become HBsAg negative will be determined for each vaccine and for each treatment group. The times to seroconversion will be calculated in months.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=9 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=17 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Percentage of Participants With HBsAg Seroconversion
No seroconversion (i.e., HBsAg > LLoQ) at Month 9
|
9 Participants
|
18 Participants
|
15 Participants
|
9 Participants
|
|
Percentage of Participants With HBsAg Seroconversion
Seroconversion (i.e., HBsAg < LLoQ) at Month 9
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: ITT Analysis Set The overall number of particpants analyized is made up of number of participants who are HBeAg positive at baseline and have non-missing HBeAg results at Month 9. This results in a smaller analysis population than the total participants for each group
This will be determined from samples of PBMCs. The proportion of participants infected with HBeAg-positive virus at baseline who become HBeAg negative will be determined for each vaccine and for each treatment group. The times to seroconversion will be calculated in months.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=1 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=4 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=5 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=3 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Percentage of Participants With HBeAg Seroconversion
Seroconversion
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Percentage of Participants With HBeAg Seroconversion
No Seroconversion
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 35, Month 3 and Month 9Population: ITT Analysis Set
Changes from baseline will be calculated for each vaccine and for each treatment group.
Outcome measures
| Measure |
Group 1 (MVA-HBV)
n=10 Participants
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 Participants
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Month 9 · < 20 IU/mL HBV DNA detected
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Baseline · No HBV DNA detected
|
7 Participants
|
16 Participants
|
14 Participants
|
7 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Baseline · < 20 IU/mL HBV DNA detected
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Baseline · ≥ 20 IU/mL HBV DNA detected
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Day 35 · No HBV DNA detected
|
8 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Day 35 · < 20 IU/mL HBV DNA detected
|
1 Participants
|
7 Participants
|
6 Participants
|
1 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Day 35 · ≥ 20 IU/mL HBV DNA detected
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Month 3 · No HBV DNA detected
|
6 Participants
|
14 Participants
|
13 Participants
|
7 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Month 3 · < 20 IU/mL HBV DNA detected
|
3 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Month 3 · ≥ 20 IU/mL HBV DNA detected
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Month 9 · No HBV DNA detected
|
10 Participants
|
16 Participants
|
16 Participants
|
7 Participants
|
|
Percentage of Participants With Reduction of Hepatitis B DNA
Month 9 · ≥ 20 IU/mL HBV DNA detected
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1 (MVA-HBV)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2 (ChAdOx1-HBV, MVA-HBV)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (MVA-HBV)
n=10 participants at risk
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 participants at risk
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 participants at risk
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 participants at risk
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Eye disorders
RHEGMATOGENOUS RETINAL DETACHMENT OD (RIGHT EYE (OCULUS DEXTER)
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Respiratory, thoracic and mediastinal disorders
POLYPOSIS OVER RIGHT MAXILARY SINUSITIS
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
Other adverse events
| Measure |
Group 1 (MVA-HBV)
n=10 participants at risk
Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 2 (ChAdOx1-HBV, MVA-HBV)
n=18 participants at risk
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
|
Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)
n=18 participants at risk
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)
n=9 participants at risk
Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
2/18 • Number of events 2 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Conjunctivitis
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Fungal infection
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Gingivitis
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Laryngopharyngitis
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
1/9 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
2/18 • Number of events 2 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 3 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
1/9 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Intestinal metaplasia
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
1/9 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
1/9 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
1/9 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
2/18 • Number of events 2 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
2/18 • Number of events 2 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Investigations
Weight increased
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
2/18 • Number of events 2 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
General disorders
Chest pain
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
General disorders
Fatigue
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
General disorders
Pain
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
11.1%
1/9 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Psychiatric disorders
Rapid eye movement sleep behaviour disorder
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Eye disorders
Cataract
|
10.0%
1/10 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/10 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/18 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
0.00%
0/9 • Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit. Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
|
Additional Information
Chief Medical Officer
Barinthus Biotherapeutics
Phone: +44 (0) 1865 818 808
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement restricting the right of the Participating Organisation and/or Principal Investigator to publish trial results, which may not be before the first multi-site publication. Following this, Participating Organisation and/or Principal Investigator may publish results, subject to Sponsor's prior review and comment (within 60 days). Sponsor can request a delay of publication up to six (6) months to enable protection of its proprietary information and/or IPR and know-how.
- Publication restrictions are in place
Restriction type: OTHER