Trial Outcomes & Findings for Controlled Human Infection Model Challenge/Rechallenge (NCT NCT04992520)
NCT ID: NCT04992520
Last Updated: 2025-01-31
Results Overview
Shigellosis was defined as: * Severe diarrhea: ≥ 6 loose (grade 3-5) stools within 24 hours or \>800 - 999 g loose stools within any 24-hour window, or * Moderate diarrhea (4 - 5 loose stools within 24 hours or 401-800 g loose stools within any 24-hour window) with fever (oral temperature of ≥ 101.2°F / 38°C) OR with ≥ 1 moderate constitutional or enteric symptom OR ≥ 2 episodes of vomiting in a 24-hour period, or * Dysentery: ≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours AND fever OR ≥ 1 moderate constitutional/enteric symptom OR ≥ 2 episodes of vomiting in 24 hours. Constitutional/Enteric symptoms include nausea, abdominal cramps/pain, myalgia, arthralgia, or malaise. Stools were graded on the following scale: * Grade 1, firm formed; * Grade 2, soft formed; * Grade 3, viscous opaque liquid or semi-liquid; * Grade 4, watery opaque liquid; * Grade 5, clear watery or mucoid liquid. Outcome data were evaluated by an independent, blinded adjudication board.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)
Results posted on
2025-01-31
Participant Flow
This was a single-center controlled human infection model (CHIM) study conducted at the Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. Healthy volunteers not previously exposed to Shigella ("Naive") were recruited for the study; once informed consent was obtained, participants were admitted to the inpatient unit at CIR for Shigella challenge and subsequent rechallenge with a different Shigella strain.
Naive participants were challenged with either Shigella sonnei strain 53G (Group 1A) or Shigella flexneri 2a strain 2457T (Group 2A). Approximately 3 months later, participants who continued to meet eligibility criteria received a 2nd challenge with the other Shigella strain ("Veterans"). Additional naive volunteers were enrolled alongside the veteran participants receiving their 2nd challenge; both received the same challenge agent to allow a comparison of shigellosis rates across the groups.
Participant milestones
| Measure |
Group 1A: S. Sonnei 53G
Naïve participants were challenged with 1500 colony forming units (CFU) of Shigella sonnei (S. sonnei) strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of Shigella flexneri (S. flexneri) 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Part A: First Challenge
STARTED
|
22
|
0
|
0
|
13
|
0
|
0
|
|
Part A: First Challenge
COMPLETED
|
21
|
0
|
0
|
11
|
0
|
0
|
|
Part A: First Challenge
NOT COMPLETED
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Part B: 3 Months Later/Second Challenge
STARTED
|
0
|
5
|
19
|
0
|
6
|
10
|
|
Part B: 3 Months Later/Second Challenge
COMPLETED
|
0
|
5
|
17
|
0
|
6
|
9
|
|
Part B: 3 Months Later/Second Challenge
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1A: S. Sonnei 53G
Naïve participants were challenged with 1500 colony forming units (CFU) of Shigella sonnei (S. sonnei) strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of Shigella flexneri (S. flexneri) 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Part A: First Challenge
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Part A: First Challenge
Non-compliance
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part B: 3 Months Later/Second Challenge
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Part B: 3 Months Later/Second Challenge
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Controlled Human Infection Model Challenge/Rechallenge
Baseline characteristics by cohort
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=13 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.41 years
STANDARD_DEVIATION 7.98 • n=5 Participants
|
37.20 years
STANDARD_DEVIATION 7.76 • n=7 Participants
|
—
|
34.92 years
STANDARD_DEVIATION 11.77 • n=4 Participants
|
32.67 years
STANDARD_DEVIATION 7.58 • n=21 Participants
|
—
|
35.59 years
STANDARD_DEVIATION 8.96 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
—
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
—
|
36 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
—
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
13 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
—
|
44 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
11 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
—
|
34 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
—
|
8 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
—
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
—
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Population: Per-Protocol Population included participants who received the challenge dose and had no major protocol violations that were determined to potentially interfere with the clinical assessment.
Shigellosis was defined as: * Severe diarrhea: ≥ 6 loose (grade 3-5) stools within 24 hours or \>800 - 999 g loose stools within any 24-hour window, or * Moderate diarrhea (4 - 5 loose stools within 24 hours or 401-800 g loose stools within any 24-hour window) with fever (oral temperature of ≥ 101.2°F / 38°C) OR with ≥ 1 moderate constitutional or enteric symptom OR ≥ 2 episodes of vomiting in a 24-hour period, or * Dysentery: ≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours AND fever OR ≥ 1 moderate constitutional/enteric symptom OR ≥ 2 episodes of vomiting in 24 hours. Constitutional/Enteric symptoms include nausea, abdominal cramps/pain, myalgia, arthralgia, or malaise. Stools were graded on the following scale: * Grade 1, firm formed; * Grade 2, soft formed; * Grade 3, viscous opaque liquid or semi-liquid; * Grade 4, watery opaque liquid; * Grade 5, clear watery or mucoid liquid. Outcome data were evaluated by an independent, blinded adjudication board.
Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Shigellosis Following Shigella Challenge
|
59.1 percentage of participants
Interval 36.4 to 79.3
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
15.8 percentage of participants
Interval 3.4 to 39.6
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
50.0 percentage of participants
Interval 18.7 to 81.3
|
SECONDARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Population: Per Protocol Population
During the 8-day inpatient period after each challenge all stools were weighed and graded according to the following scale: * Grade 1, firm formed; * Grade 2, soft formed; * Grade 3, viscous opaque liquid or semi-liquid; * Grade 4, watery opaque liquid; * Grade 5, clear watery or mucoid liquid.
Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Maximum Volume of Loose Stools in Any 24-hour Period
|
446.86 grams
Standard Deviation 383.47
|
656.80 grams
Standard Deviation 450.93
|
225.32 grams
Standard Deviation 285.73
|
459.67 grams
Standard Deviation 530.36
|
824.33 grams
Standard Deviation 852.98
|
294.30 grams
Standard Deviation 286.32
|
SECONDARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Population: Per Protocol Population
During the 8-day inpatient period after each challenge all stools were weighed and graded according to the following scale: * Grade 1, firm formed; * Grade 2, soft formed; * Grade 3, viscous opaque liquid or semi-liquid; * Grade 4, watery opaque liquid; * Grade 5, clear watery or mucoid liquid. Severe diarrhea was defined as ≥ 6 loose (Grade 3-5) stools within 24 hours or \> 800 grams of loose (Grade 3-5) stools within any 24-hour window.
Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Severe Diarrhea
|
50.0 percentage of participants
|
40.0 percentage of participants
|
10.5 percentage of participants
|
25.0 percentage of participants
|
50.0 percentage of participants
|
30.0 percentage of participants
|
SECONDARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Population: Per Protocol Population
During the 8-day inpatient period after each challenge all stools were weighed and graded according to the following scale: * Grade 1, firm formed; * Grade 2, soft formed; * Grade 3, viscous opaque liquid or semi-liquid; * Grade 4, watery opaque liquid; * Grade 5, clear watery or mucoid liquid. Participants met the criteria for diarrhea if they had ≥ 2 loose (Grade 3-5) stools weighing ≥ 200 grams within any 48-hour window or any loose stools weighing ≥ 300 grams.
Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Diarrhea of Any Severity
|
77.3 percentage of participants
|
80.0 percentage of participants
|
42.1 percentage of participants
|
66.7 percentage of participants
|
83.3 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Population: Per Protocol Population
During the 8-day inpatient period after each challenge all stools were weighed and graded according to the following scale: * Grade 1, firm formed; * Grade 2, soft formed; * Grade 3, viscous opaque liquid or semi-liquid; * Grade 4, watery opaque liquid; * Grade 5, clear watery or mucoid liquid.
Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Total Weight of Grade 3-5 Stools Per Participant After Challenge
|
768.95 grams
Standard Deviation 741.61
|
884.40 grams
Standard Deviation 531.71
|
352.74 grams
Standard Deviation 479.56
|
747.58 grams
Standard Deviation 692.05
|
979.50 grams
Standard Deviation 1008.34
|
402.40 grams
Standard Deviation 403.44
|
SECONDARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Population: Per Protocol Population
During the 8-day inpatient period after each challenge, nausea, vomiting, anorexia, and abdominal pain/cramps were monitored and graded (except for vomiting) according to the following: Mild: Discomfort noted, but no disruption of normal daily activities; slightly bothersome; relieved with or without symptomatic treatment. Moderate: Discomfort sufficient to reduce or affect normal daily activity to some degree; bothersome; interferes with activities, only partially relieved with symptomatic treatment. Severe: Discomfort sufficient to reduce or affect normal daily activity considerably; prevents regular activities; not relieved with symptomatic treatment. Vomiting was graded according the the following: Mild: One episode within a 24-hour period Moderate: Two episodes within a 24-hour period Severe: Three or more episodes within a 24-hour period.
Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Nausea, Vomiting, Anorexia, Abdominal Pain/Cramps Rated as Moderate to Severe
Moderate/Severe Nausea
|
18.2 percentage of participants
|
0.0 percentage of participants
|
10.5 percentage of participants
|
58.3 percentage of participants
|
16.7 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Nausea, Vomiting, Anorexia, Abdominal Pain/Cramps Rated as Moderate to Severe
Moderate/Severe Vomiting
|
9.1 percentage of participants
|
0.0 percentage of participants
|
5.3 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Nausea, Vomiting, Anorexia, Abdominal Pain/Cramps Rated as Moderate to Severe
Moderate/Severe Anorexia
|
13.6 percentage of participants
|
0.0 percentage of participants
|
15.8 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants With Nausea, Vomiting, Anorexia, Abdominal Pain/Cramps Rated as Moderate to Severe
Moderate/Severe Abdominal Pain/Cramps
|
22.7 percentage of participants
|
0.0 percentage of participants
|
21.1 percentage of participants
|
41.7 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Population: Per Protocol Population
During the 8-day inpatient period after each challenge all stools were weighed and graded according to the following scale: * Grade 1, firm formed; * Grade 2, soft formed; * Grade 3, viscous opaque liquid or semi-liquid; * Grade 4, watery opaque liquid; * Grade 5, clear watery or mucoid liquid. Dysentery was defined as ≥ 2 loose stools (Grade 3-5) with gross blood (hemoccult positive) in 24 hours AND fever OR ≥ 1 moderate constitutional/enteric symptom OR ≥2 episodes of vomiting in 24 hours. Constitutional/enteric symptoms included nausea, abdominal cramps/pain, myalgia, arthralgia, and malaise.
Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Dysentery
|
40.9 percentage of participants
|
20.0 percentage of participants
|
10.5 percentage of participants
|
41.7 percentage of participants
|
33.3 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: From challenge administration to the end of the 8-day inpatient period (Days 1-8 and Days 90-97 for challenge 2)Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Time to Onset of Diarrhea
|
62.45 hours
Standard Deviation 28.75
|
53.95 hours
Standard Deviation 19.50
|
78.22 hours
Standard Deviation 42.16
|
53.47 hours
Standard Deviation 35.25
|
60.34 hours
Standard Deviation 24.23
|
47.46 hours
Standard Deviation 22.31
|
SECONDARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Population: Per Protocol Population
During the 8-day inpatient period after each challenge all stools were weighed and graded according to the following scale: * Grade 1, firm formed; * Grade 2, soft formed; * Grade 3, viscous opaque liquid or semi-liquid; * Grade 4, watery opaque liquid; * Grade 5, clear watery or mucoid liquid. More severe diarrhea was defined as ≥ 10 loose (Grade 3-5) stools within 24 hours or ≥ 1000 grams loose stools within any 24-hour window.
Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Number of Participants With More Severe Diarrhea
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Population: Per Protocol Population
Fever: measured oral temperature ≥ 38°C confirmed within about 20 minutes.
Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Fever After Challenge
|
11 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Population: Per Protocol Population
The Shigella clinical severity score is a composite, ordinal disease score that consists of three parameters: self-reported symptoms (arthralgia, nausea, myalgia, headache, anorexia, and abdominal cramps and pain), clinical signs (blood in stool, fever, and vomiting) and stool output (maximum loose stool output / 24 hours). Each parameter is scored based off maximum severity clinical signs, self-reported symptoms and stool output experienced over over the 8-day period. The Shigella clinical severity score ranges from 0 to 9, where 0 = no or mild symptoms only and 9 = severe symptoms.
Outcome measures
| Measure |
Group 1A: S. Sonnei 53G
n=22 Participants
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 Participants
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 Participants
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=12 Participants
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 Participants
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 Participants
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Shigella Clinical Severity Score
|
2.95 score on a scale
Standard Deviation 2.38
|
3.00 score on a scale
Standard Deviation 2.55
|
1.47 score on a scale
Standard Deviation 1.74
|
4.00 score on a scale
Standard Deviation 2.70
|
3.50 score on a scale
Standard Deviation 2.66
|
3.90 score on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)Analysis of stool samples to quantify challenge strains in the stool are not yet complete. Data will be reported once the assays have been completed.
Outcome measures
Outcome data not reported
Adverse Events
Group 1A: S. Sonnei 53G
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Group 1B: S. Flexneri 2a (Naive)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 1B: S. Flexneri 2a (Veteran)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Group 2A: S. Flexneri 2a
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2B: S. Sonnei 53G (Naive)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2B: S. Sonnei 53G (Veteran)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1A: S. Sonnei 53G
n=22 participants at risk
Naïve participants were challenged with 1500 CFU of S. sonnei strain 53G.
|
Group 1B: S. Flexneri 2a (Naive)
n=5 participants at risk
At least 3 months after the challenge in Group 1A, newly recruited naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 1B: S. Flexneri 2a (Veteran)
n=19 participants at risk
At least 3 months after challenge with S. sonnei 53G in Group 1A, participants received a 2nd challenge with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2A: S. Flexneri 2a
n=13 participants at risk
Naïve participants were challenged with 1500 CFU of S. flexneri 2a strain 2457T.
|
Group 2B: S. Sonnei 53G (Naive)
n=6 participants at risk
At least 3 months after the challenge in Group 2A, newly recruited naïve participants were challenged with 1500 CFU of S. sonnei 53G.
|
Group 2B: S. Sonnei 53G (Veteran)
n=10 participants at risk
At least 3 months after challenge with S. flexneri 2a in Group 2A, participants received a 2nd challenge with 1500 CFU of S. sonnei 53G.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Cardiac disorders
Tachycardia
|
50.0%
11/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
3/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
26.3%
5/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
38.5%
5/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
66.7%
4/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
40.0%
4/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Eye disorders
Eye pain
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Abdominal distension
|
27.3%
6/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
23.1%
3/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
50.0%
3/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
30.0%
3/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Abdominal pain
|
63.6%
14/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
36.8%
7/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
38.5%
5/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
50.0%
3/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
6/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Abdominal tenderness
|
18.2%
4/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
15.4%
2/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
50.0%
3/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Constipation
|
18.2%
4/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
1/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Defaecation urgency
|
50.0%
11/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
3/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
21.1%
4/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
38.5%
5/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
66.7%
4/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
40.0%
4/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Diarrhoea
|
77.3%
17/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
80.0%
4/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
47.4%
9/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
61.5%
8/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
83.3%
5/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
6/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Eructation
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Flatulence
|
40.9%
9/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
31.6%
6/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
46.2%
6/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
66.7%
4/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
40.0%
4/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
50.0%
11/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
1/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
23.1%
3/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Nausea
|
31.8%
7/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
15.8%
3/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
53.8%
7/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
66.7%
4/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
40.0%
4/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
7.7%
1/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Rectal tenesmus
|
13.6%
3/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
1/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
2/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Toothache
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
7.7%
1/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
3/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
30.8%
4/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
2/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
General disorders
Chills
|
40.9%
9/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
1/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
21.1%
4/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
38.5%
5/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
66.7%
4/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
40.0%
4/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
General disorders
Fatigue
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
7.7%
1/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
General disorders
Malaise
|
45.5%
10/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
3/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
21.1%
4/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
53.8%
7/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
83.3%
5/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
6/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
General disorders
Pyrexia
|
50.0%
11/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
3/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
46.2%
6/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
33.3%
2/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
40.0%
4/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Infections and infestations
COVID-19
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Infections and infestations
Dysentery
|
40.9%
9/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
1/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
38.5%
5/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
33.3%
2/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
6/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Infections and infestations
Fungal foot infection
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
7.7%
1/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
1/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Investigations
Blood glucose increased
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Investigations
Blood pressure increased
|
18.2%
4/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
40.0%
2/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
21.1%
4/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
15.4%
2/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Investigations
Blood pressure systolic increased
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
7.7%
1/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Investigations
Orthostatic heart rate response increased
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
63.6%
14/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
3/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
15.8%
3/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
61.5%
8/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
83.3%
5/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
70.0%
7/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.6%
3/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
15.4%
2/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
2/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
1/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
15.4%
2/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
33.3%
2/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
2/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
1/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.3%
6/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
1/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
15.8%
3/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
53.8%
7/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
50.0%
3/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
30.0%
3/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.6%
3/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Nervous system disorders
Dizziness
|
36.4%
8/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
53.8%
7/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
50.0%
3/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
30.0%
3/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Nervous system disorders
Headache
|
54.5%
12/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
3/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
31.6%
6/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
61.5%
8/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
83.3%
5/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
60.0%
6/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Nervous system disorders
Syncope
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.0%
1/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Psychiatric disorders
Insomnia
|
13.6%
3/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
20.0%
1/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
33.3%
2/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
16.7%
1/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.5%
1/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
5.3%
1/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Vascular disorders
Hypertension
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
10.5%
2/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/5 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/19 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
7.7%
1/13 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/6 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
0.00%
0/10 • Serious adverse events were collected up to 180 days after last challenge (a total of 270 days for participants who received 2 challenge doses). Non-serious adverse events were collected for up to 28 days after each challenge (Days 1-28 and approximate Days 90-118).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place