Trial Outcomes & Findings for A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis (NCT NCT00316602)
NCT ID: NCT00316602
Last Updated: 2019-01-09
Results Overview
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
632 participants
Primary outcome timeframe
week 6
Results posted on
2019-01-09
Participant Flow
Participant milestones
| Measure |
Healthy Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
IMVAMUNE: Subjects receiving two subcutaneous vaccinations
|
Atopic Dermatitis Participants
Vaccinia naive subjects with diagnosed Atopic Dermatitis. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] \<= 30), receiving two doses of MVA-BN (IMVAMUNE)
IMVAMUNE: Subjects receiving two subcutaneous vaccinations
|
|---|---|---|
|
Overall Study
STARTED
|
282
|
350
|
|
Overall Study
COMPLETED
|
272
|
325
|
|
Overall Study
NOT COMPLETED
|
10
|
25
|
Reasons for withdrawal
| Measure |
Healthy Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
IMVAMUNE: Subjects receiving two subcutaneous vaccinations
|
Atopic Dermatitis Participants
Vaccinia naive subjects with diagnosed Atopic Dermatitis. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] \<= 30), receiving two doses of MVA-BN (IMVAMUNE)
IMVAMUNE: Subjects receiving two subcutaneous vaccinations
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Subject unwilling/unable to comply with
|
3
|
17
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Other
|
3
|
6
|
Baseline Characteristics
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Healthy Participants
n=282 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=350 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
Total
n=632 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.4 years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
27.9 years
STANDARD_DEVIATION 6.33 • n=7 Participants
|
27.7 years
STANDARD_DEVIATION 6.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
373 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
24 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
124 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
109 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental/Asian
|
20 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
194 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
437 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
88 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 6Population: Per Protocol Set
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Healthy Participants
n=194 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=257 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
Percentage of Participants With Seroconversion by ELISA
|
98.5 percentage of subjects
Interval 95.5 to 99.7
|
97.3 percentage of subjects
Interval 94.5 to 98.9
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Per Protocol Set
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Healthy Participants
n=194 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=257 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
Percentage of Participants With Seroconversion by ELISA
Week 4
|
85.4 percentage of subjects
Interval 79.6 to 90.1
|
85.4 percentage of subjects
Interval 80.5 to 89.5
|
|
Percentage of Participants With Seroconversion by ELISA
Week 6
|
98.5 percentage of subjects
Interval 95.5 to 99.7
|
97.3 percentage of subjects
Interval 94.5 to 98.9
|
|
Percentage of Participants With Seroconversion by ELISA
Week 8
|
98.4 percentage of subjects
Interval 95.4 to 99.7
|
97.1 percentage of subjects
Interval 94.2 to 98.8
|
|
Percentage of Participants With Seroconversion by ELISA
Week 32
|
68.1 percentage of subjects
Interval 57.7 to 77.3
|
75.0 percentage of subjects
Interval 63.7 to 84.2
|
|
Percentage of Participants With Seroconversion by ELISA
Week 1
|
12.5 percentage of subjects
Interval 8.1 to 18.2
|
22.9 percentage of subjects
Interval 17.8 to 28.6
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Per Protocol Set
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Healthy Participants
n=194 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=257 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
ELISA GMT
Week 0
|
1.4 Titer
Interval 1.2 to 1.7
|
1.7 Titer
Interval 1.4 to 2.0
|
|
ELISA GMT
Week 1
|
2.2 Titer
Interval 1.7 to 2.9
|
3.4 Titer
Interval 2.6 to 4.4
|
|
ELISA GMT
Week 4
|
60.0 Titer
Interval 47.2 to 76.4
|
62.3 Titer
Interval 50.1 to 77.4
|
|
ELISA GMT
Week 6
|
499.4 Titer
Interval 417.1 to 598.0
|
532.9 Titer
Interval 452.9 to 627.1
|
|
ELISA GMT
Week 8
|
298.0 Titer
Interval 252.3 to 351.8
|
314.3 Titer
Interval 269.2 to 366.8
|
|
ELISA GMT
Week 32
|
21.4 Titer
Interval 14.2 to 32.3
|
33.2 Titer
Interval 21.7 to 50.6
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Per Protocol Set
Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Outcome measures
| Measure |
Healthy Participants
n=194 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=257 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
Percentage of Participants With Seroconversion by PRNT
Week 1
|
5.4 percentage of subjects
Interval 2.6 to 9.8
|
5.6 percentage of subjects
Interval 3.1 to 9.3
|
|
Percentage of Participants With Seroconversion by PRNT
Week 4
|
24.5 percentage of subjects
Interval 18.6 to 31.2
|
26.8 percentage of subjects
Interval 21.4 to 32.7
|
|
Percentage of Participants With Seroconversion by PRNT
Week 6
|
86.6 percentage of subjects
Interval 81.0 to 91.1
|
90.3 percentage of subjects
Interval 86.0 to 93.6
|
|
Percentage of Participants With Seroconversion by PRNT
Week 8
|
76.1 percentage of subjects
Interval 69.3 to 82.0
|
80.7 percentage of subjects
Interval 75.2 to 85.5
|
|
Percentage of Participants With Seroconversion by PRNT
Week 32
|
22.3 percentage of subjects
Interval 14.4 to 32.1
|
19.7 percentage of subjects
Interval 11.5 to 30.5
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Per Protocol Set
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Outcome measures
| Measure |
Healthy Participants
n=194 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=257 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
PRNT GMT
Week 0
|
1.1 Titer
Interval 1.0 to 1.2
|
1.2 Titer
Interval 1.1 to 1.4
|
|
PRNT GMT
Week 1
|
1.3 Titer
Interval 1.1 to 1.5
|
1.5 Titer
Interval 1.2 to 1.7
|
|
PRNT GMT
Week 4
|
2.4 Titer
Interval 1.9 to 3.1
|
2.8 Titer
Interval 2.2 to 3.5
|
|
PRNT GMT
Week 6
|
34.6 Titer
Interval 26.4 to 45.3
|
47.7 Titer
Interval 38.1 to 59.8
|
|
PRNT GMT
Week 8
|
15.7 Titer
Interval 12.0 to 20.6
|
21.9 Titer
Interval 17.2 to 27.9
|
|
PRNT GMT
Week 32
|
2.2 Titer
Interval 1.6 to 2.9
|
2.3 Titer
Interval 1.6 to 3.5
|
SECONDARY outcome
Timeframe: within 6 weeksPopulation: ELISPOT Analysis Set
Number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) per 10\^6 PBMC in response to restimulation with MVA-BN detected by ELISPOT assay
Outcome measures
| Measure |
Healthy Participants
n=46 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=71 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
ELISPOT IFN-γ Values
Week 0
|
107.5 Spot Forming Units / 10^6 PBMC
Interval 0.0 to 775.0
|
109.0 Spot Forming Units / 10^6 PBMC
Interval 0.0 to 871.0
|
|
ELISPOT IFN-γ Values
Week 1
|
106.5 Spot Forming Units / 10^6 PBMC
Interval 0.0 to 674.0
|
166.0 Spot Forming Units / 10^6 PBMC
Interval 0.0 to 1800.0
|
|
ELISPOT IFN-γ Values
Week 6
|
276.5 Spot Forming Units / 10^6 PBMC
Interval 0.0 to 1800.0
|
334.0 Spot Forming Units / 10^6 PBMC
Interval 0.0 to 1800.0
|
SECONDARY outcome
Timeframe: within 32 weeksPopulation: Safety Analysis Set
Occurrence, relationship and intensity of any serious AE (SAE)
Outcome measures
| Measure |
Healthy Participants
n=282 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=350 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
Number of Participants With SAEs
Any SAE
|
3 Participants
|
3 Participants
|
|
Number of Participants With SAEs
Any SAE with intensity >= Grade 3
|
3 Participants
|
2 Participants
|
|
Number of Participants With SAEs
Any SAE assessed as related to vaccine
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 29 days after vaccinationPopulation: Safety Analysis Set
Number of Participants with any Grade \>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.
Outcome measures
| Measure |
Healthy Participants
n=282 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=350 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
Number of Participants With Related Grade >=3 Adverse Events
|
16 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: within 8 days after any vaccinationPopulation: Safety Analysis Set
Number of Participants with and Intensity of solicited local AEs (erythema, swelling and pain). Percentages based on subjects with at least one completed diary card.
Outcome measures
| Measure |
Healthy Participants
n=282 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=345 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
Number of Participants With Solicited Local Adverse Events
Swelling : Total
|
115 Participants
|
180 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Swelling : Grade >=2
|
21 Participants
|
45 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Pain : Total
|
233 Participants
|
283 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Pain : Grade >=2
|
117 Participants
|
152 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Pain : Grade >=3
|
31 Participants
|
53 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Swelling : Grade >=3
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Erythema : Total
|
139 Participants
|
211 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Erythema : Grade >=2
|
35 Participants
|
66 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Erythema : Grade >=3
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: within 8 days after any vaccinationPopulation: Safety Analysis Set
Number of Participants with solicited systemic/general AEs (elevated body temperature, headache, myalgia, nausea, fatigue and chills): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Outcome measures
| Measure |
Healthy Participants
n=282 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=345 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
Number of Participants With Solicited General AEs
Headache : Total
|
98 Participants
|
163 Participants
|
|
Number of Participants With Solicited General AEs
Headache : Related
|
76 Participants
|
119 Participants
|
|
Number of Participants With Solicited General AEs
Headache : Grade >=3
|
9 Participants
|
26 Participants
|
|
Number of Participants With Solicited General AEs
Headache : Related - Grade >=3
|
5 Participants
|
18 Participants
|
|
Number of Participants With Solicited General AEs
Myalgia : Total
|
98 Participants
|
153 Participants
|
|
Number of Participants With Solicited General AEs
Body Temperature increased : Total
|
23 Participants
|
28 Participants
|
|
Number of Participants With Solicited General AEs
Body Temperature increased : Related
|
16 Participants
|
20 Participants
|
|
Number of Participants With Solicited General AEs
Body Temperature increased : Grade >=3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited General AEs
Body Temperature increased : Related - Grade >=3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited General AEs
Chills : Related
|
19 Participants
|
39 Participants
|
|
Number of Participants With Solicited General AEs
Chills : Grade >=3
|
4 Participants
|
7 Participants
|
|
Number of Participants With Solicited General AEs
Chills : Related - Grade >=3
|
4 Participants
|
3 Participants
|
|
Number of Participants With Solicited General AEs
Nausea : Total
|
41 Participants
|
80 Participants
|
|
Number of Participants With Solicited General AEs
Myalgia : Related
|
88 Participants
|
121 Participants
|
|
Number of Participants With Solicited General AEs
Myalgia : Grade >=3
|
9 Participants
|
14 Participants
|
|
Number of Participants With Solicited General AEs
Myalgia : Related - Grade >=3
|
8 Participants
|
9 Participants
|
|
Number of Participants With Solicited General AEs
Chills : Total
|
22 Participants
|
55 Participants
|
|
Number of Participants With Solicited General AEs
Nausea : Related
|
29 Participants
|
49 Participants
|
|
Number of Participants With Solicited General AEs
Nausea : Grade >=3
|
6 Participants
|
8 Participants
|
|
Number of Participants With Solicited General AEs
Nausea : Related - Grade >=3
|
4 Participants
|
5 Participants
|
|
Number of Participants With Solicited General AEs
Fatigue : Total
|
75 Participants
|
124 Participants
|
|
Number of Participants With Solicited General AEs
Fatigue : Related
|
53 Participants
|
90 Participants
|
|
Number of Participants With Solicited General AEs
Fatigue : Grade >=3
|
9 Participants
|
16 Participants
|
|
Number of Participants With Solicited General AEs
Fatigue : Related - Grade >=3
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Safety Analysis Set
Occurrence of unsolicited non-serious AEs by Intensity
Outcome measures
| Measure |
Healthy Participants
n=282 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=350 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
Number of Unsolicited Non-serious Adverse Events: Intensity
Total
|
432 events
|
538 events
|
|
Number of Unsolicited Non-serious Adverse Events: Intensity
Grade 1
|
298 events
|
432 events
|
|
Number of Unsolicited Non-serious Adverse Events: Intensity
Grade 2
|
108 events
|
86 events
|
|
Number of Unsolicited Non-serious Adverse Events: Intensity
Grade 3
|
26 events
|
20 events
|
|
Number of Unsolicited Non-serious Adverse Events: Intensity
Grade 4
|
0 events
|
0 events
|
|
Number of Unsolicited Non-serious Adverse Events: Intensity
Missing
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: within 29 days after any vaccinationPopulation: Safety Analysis Set
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Outcome measures
| Measure |
Healthy Participants
n=282 Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=350 Participants
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
None
|
142 events
|
170 events
|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Unlikely
|
117 events
|
86 events
|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Possible
|
76 events
|
111 events
|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Probable
|
59 events
|
92 events
|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Definite
|
38 events
|
79 events
|
|
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Total
|
432 events
|
538 events
|
Adverse Events
Healthy Participants
Serious events: 3 serious events
Other events: 133 other events
Deaths: 0 deaths
Atopic Dermatitis Participants
Serious events: 3 serious events
Other events: 196 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy Participants
n=282 participants at risk
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=350 participants at risk
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
Eye disorders
Extraocular muscle paresis
|
0.35%
1/282 • Number of events 1 • 32 weeks
|
0.00%
0/350 • 32 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.35%
1/282 • Number of events 1 • 32 weeks
|
0.00%
0/350 • 32 weeks
|
|
Injury, poisoning and procedural complications
Loss of consciousness
|
0.35%
1/282 • Number of events 1 • 32 weeks
|
0.00%
0/350 • 32 weeks
|
|
Psychiatric disorders
Panic attack
|
0.35%
1/282 • Number of events 1 • 32 weeks
|
0.00%
0/350 • 32 weeks
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/282 • 32 weeks
|
0.29%
1/350 • Number of events 2 • 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/282 • 32 weeks
|
0.29%
1/350 • Number of events 1 • 32 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/282 • 32 weeks
|
0.29%
1/350 • Number of events 1 • 32 weeks
|
Other adverse events
| Measure |
Healthy Participants
n=282 participants at risk
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
|
Atopic Dermatitis Participants
n=350 participants at risk
Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30)
|
|---|---|---|
|
General disorders
Injection site pruritus
|
17.0%
48/282 • 32 weeks
|
28.6%
100/350 • 32 weeks
|
|
General disorders
Injection site bruising
|
0.71%
2/282 • 32 weeks
|
2.0%
7/350 • 32 weeks
|
|
General disorders
Injection site induration
|
2.1%
6/282 • 32 weeks
|
0.86%
3/350 • 32 weeks
|
|
Investigations
Troponin I increased
|
13.1%
37/282 • 32 weeks
|
15.4%
54/350 • 32 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
11/282 • 32 weeks
|
6.6%
23/350 • 32 weeks
|
|
Infections and infestations
Influenza
|
2.8%
8/282 • 32 weeks
|
3.1%
11/350 • 32 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
9/282 • 32 weeks
|
1.7%
6/350 • 32 weeks
|
|
Infections and infestations
Pharyngitis
|
3.2%
9/282 • 32 weeks
|
1.1%
4/350 • 32 weeks
|
|
Infections and infestations
Pharyngotonsillitis
|
2.5%
7/282 • 32 weeks
|
0.86%
3/350 • 32 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
7/282 • 32 weeks
|
2.6%
9/350 • 32 weeks
|
|
Nervous system disorders
Headache
|
6.7%
19/282 • 32 weeks
|
4.6%
16/350 • 32 weeks
|
|
Nervous system disorders
Dizziness
|
2.5%
7/282 • 32 weeks
|
3.1%
11/350 • 32 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/282 • 32 weeks
|
4.3%
15/350 • 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
8/282 • 32 weeks
|
0.86%
3/350 • 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.8%
8/282 • 32 weeks
|
0.57%
2/350 • 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.1%
6/282 • 32 weeks
|
0.86%
3/350 • 32 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.5%
7/282 • 32 weeks
|
2.3%
8/350 • 32 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place