Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, Smallpox, Vaccination
Brief summary
The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
Interventions
BIOLOGICALIMVAMUNE
Subjects receiving two subcutaneous vaccinations
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Bavarian Nordic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Group 1 (Healthy Participants): Subjects without present or history of any kind of atopy. Group 2 (Atopic Dermatitis Participants): Subjects with diagnosed atopic dermatitis. All study subjects: 1. Male and female subjects between 18 and 40 years of age without history of smallpox vaccination. 2. Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination. 3. Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last vaccination. 4. Lab values without clinically significant findings. 5. Electrocardiogram (ECG) without clinically significant findings.
Exclusion criteria
1. Pregnant or breast-feeding women. 2. Uncontrolled serious infection i.e. not responding to antimicrobial therapy. 3. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. 4. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment. 5. History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded. 6. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure. 7. History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years. 8. Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool: (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to volunteers 20 years of age and older. 9. History of anaphylaxis or severe allergic reaction. 10. Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy. 11. Administration of immunomodulatory substances.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion by ELISA | week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ELISA GMT | within 32 weeks | 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'. |
| Percentage of Participants With Seroconversion by PRNT | within 32 weeks | 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. |
| PRNT GMT | within 32 weeks | 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'. |
| ELISPOT IFN-γ Values | within 6 weeks | 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 |
| Number of Participants With SAEs | within 32 weeks | Occurrence, relationship and intensity of any serious AE (SAE) |
| Percentage of Participants With Seroconversion by ELISA | within 32 weeks | 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. |
| Number of Participants With Solicited Local Adverse Events | within 8 days after any vaccination | 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. |
| Number of Participants With Solicited General AEs | within 8 days after any vaccination | 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. |
| Number of Unsolicited Non-serious Adverse Events: Intensity | within 29 days after any vaccination | Occurrence of unsolicited non-serious AEs by Intensity |
| Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | within 29 days after any vaccination | Occurrence of unsolicited non-serious AEs by relationship to study vaccine |
| Number of Participants With Related Grade >=3 Adverse Events | within 29 days after vaccination | Number of Participants with any Grade \>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs. |
Countries
Mexico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Participants Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE) | 282 |
| Atopic Dermatitis 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) | 350 |
| Total | 632 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Other | 3 | 6 |
| Overall Study | Subject unwilling/unable to comply with | 3 | 17 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Atopic Dermatitis Participants | Total | Healthy Participants |
|---|---|---|---|
| Age, Continuous | 27.9 years STANDARD_DEVIATION 6.33 | 27.7 years STANDARD_DEVIATION 6.11 | 27.4 years STANDARD_DEVIATION 5.81 |
| Race/Ethnicity, Customized Black | 33 Participants | 57 Participants | 24 Participants |
| Race/Ethnicity, Customized Caucasian | 125 Participants | 249 Participants | 124 Participants |
| Race/Ethnicity, Customized Hispanic | 134 Participants | 243 Participants | 109 Participants |
| Race/Ethnicity, Customized Oriental/Asian | 49 Participants | 69 Participants | 20 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 14 Participants | 5 Participants |
| Region of Enrollment Mexico | 107 Participants | 195 Participants | 88 Participants |
| Region of Enrollment United States | 243 Participants | 437 Participants | 194 Participants |
| Sex: Female, Male Female | 223 Participants | 373 Participants | 150 Participants |
| Sex: Female, Male Male | 127 Participants | 259 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 282 | 0 / 350 |
| other Total, other adverse events | 133 / 282 | 196 / 350 |
| serious Total, serious adverse events | 3 / 282 | 3 / 350 |
Outcome results
Primary
Percentage of Participants With Seroconversion by ELISA
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.
Time frame: week 6
Population: Per Protocol Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Participants | Percentage of Participants With Seroconversion by ELISA | 98.5 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by ELISA | 97.3 percentage of subjects |
Secondary
ELISA GMT
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'.
Time frame: within 32 weeks
Population: Per Protocol Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Healthy Participants | ELISA GMT | Week 0 | 1.4 Titer |
| Healthy Participants | ELISA GMT | Week 1 | 2.2 Titer |
| Healthy Participants | ELISA GMT | Week 4 | 60.0 Titer |
| Healthy Participants | ELISA GMT | Week 6 | 499.4 Titer |
| Healthy Participants | ELISA GMT | Week 8 | 298.0 Titer |
| Healthy Participants | ELISA GMT | Week 32 | 21.4 Titer |
| Atopic Dermatitis Participants | ELISA GMT | Week 8 | 314.3 Titer |
| Atopic Dermatitis Participants | ELISA GMT | Week 0 | 1.7 Titer |
| Atopic Dermatitis Participants | ELISA GMT | Week 6 | 532.9 Titer |
| Atopic Dermatitis Participants | ELISA GMT | Week 1 | 3.4 Titer |
| Atopic Dermatitis Participants | ELISA GMT | Week 32 | 33.2 Titer |
| Atopic Dermatitis Participants | ELISA GMT | Week 4 | 62.3 Titer |
Secondary
ELISPOT IFN-γ Values
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
Time frame: within 6 weeks
Population: ELISPOT Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Participants | ELISPOT IFN-γ Values | Week 0 | 107.5 Spot Forming Units / 10^6 PBMC |
| Healthy Participants | ELISPOT IFN-γ Values | Week 1 | 106.5 Spot Forming Units / 10^6 PBMC |
| Healthy Participants | ELISPOT IFN-γ Values | Week 6 | 276.5 Spot Forming Units / 10^6 PBMC |
| Atopic Dermatitis Participants | ELISPOT IFN-γ Values | Week 0 | 109.0 Spot Forming Units / 10^6 PBMC |
| Atopic Dermatitis Participants | ELISPOT IFN-γ Values | Week 1 | 166.0 Spot Forming Units / 10^6 PBMC |
| Atopic Dermatitis Participants | ELISPOT IFN-γ Values | Week 6 | 334.0 Spot Forming Units / 10^6 PBMC |
Secondary
Number of Participants With Related Grade >=3 Adverse Events
Number of Participants with any Grade \>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.
Time frame: within 29 days after vaccination
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Participants | Number of Participants With Related Grade >=3 Adverse Events | 16 Participants |
| Atopic Dermatitis Participants | Number of Participants With Related Grade >=3 Adverse Events | 27 Participants |
Secondary
Number of Participants With SAEs
Occurrence, relationship and intensity of any serious AE (SAE)
Time frame: within 32 weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Participants | Number of Participants With SAEs | Any SAE | 3 Participants |
| Healthy Participants | Number of Participants With SAEs | Any SAE with intensity >= Grade 3 | 3 Participants |
| Healthy Participants | Number of Participants With SAEs | Any SAE assessed as related to vaccine | 1 Participants |
| Atopic Dermatitis Participants | Number of Participants With SAEs | Any SAE | 3 Participants |
| Atopic Dermatitis Participants | Number of Participants With SAEs | Any SAE with intensity >= Grade 3 | 2 Participants |
| Atopic Dermatitis Participants | Number of Participants With SAEs | Any SAE assessed as related to vaccine | 0 Participants |
Secondary
Number of Participants With Solicited General AEs
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.
Time frame: within 8 days after any vaccination
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Participants | Number of Participants With Solicited General AEs | Body Temperature increased : Related | 16 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Chills : Total | 22 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Headache : Grade >=3 | 9 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Chills : Related | 19 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Body Temperature increased : Related - Grade >=3 | 1 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Chills : Grade >=3 | 4 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Headache : Related - Grade >=3 | 5 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Chills : Related - Grade >=3 | 4 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Body Temperature increased : Total | 23 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Nausea : Total | 41 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Myalgia : Total | 98 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Nausea : Related | 29 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Headache : Total | 98 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Nausea : Grade >=3 | 6 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Myalgia : Related | 88 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Nausea : Related - Grade >=3 | 4 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Body Temperature increased : Grade >=3 | 1 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Fatigue : Total | 75 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Fatigue : Related | 53 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Myalgia : Grade >=3 | 9 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Fatigue : Grade >=3 | 9 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Headache : Related | 76 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Fatigue : Related - Grade >=3 | 5 Participants |
| Healthy Participants | Number of Participants With Solicited General AEs | Myalgia : Related - Grade >=3 | 8 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Chills : Grade >=3 | 7 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Body Temperature increased : Total | 28 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Body Temperature increased : Related | 20 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Body Temperature increased : Grade >=3 | 1 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Body Temperature increased : Related - Grade >=3 | 1 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Headache : Total | 163 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Headache : Related | 119 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Headache : Grade >=3 | 26 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Headache : Related - Grade >=3 | 18 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Myalgia : Total | 153 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Myalgia : Related | 121 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Myalgia : Grade >=3 | 14 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Myalgia : Related - Grade >=3 | 9 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Chills : Total | 55 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Chills : Related | 39 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Fatigue : Total | 124 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Chills : Related - Grade >=3 | 3 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Nausea : Total | 80 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Nausea : Related | 49 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Nausea : Grade >=3 | 8 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Nausea : Related - Grade >=3 | 5 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Fatigue : Related | 90 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Fatigue : Grade >=3 | 16 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited General AEs | Fatigue : Related - Grade >=3 | 9 Participants |
Secondary
Number of Participants With Solicited Local Adverse Events
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.
Time frame: within 8 days after any vaccination
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Participants | Number of Participants With Solicited Local Adverse Events | Pain : Grade >=2 | 117 Participants |
| Healthy Participants | Number of Participants With Solicited Local Adverse Events | Erythema : Grade >=3 | 3 Participants |
| Healthy Participants | Number of Participants With Solicited Local Adverse Events | Erythema : Total | 139 Participants |
| Healthy Participants | Number of Participants With Solicited Local Adverse Events | Swelling : Total | 115 Participants |
| Healthy Participants | Number of Participants With Solicited Local Adverse Events | Pain : Grade >=3 | 31 Participants |
| Healthy Participants | Number of Participants With Solicited Local Adverse Events | Swelling : Grade >=2 | 21 Participants |
| Healthy Participants | Number of Participants With Solicited Local Adverse Events | Erythema : Grade >=2 | 35 Participants |
| Healthy Participants | Number of Participants With Solicited Local Adverse Events | Swelling : Grade >=3 | 2 Participants |
| Healthy Participants | Number of Participants With Solicited Local Adverse Events | Pain : Total | 233 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited Local Adverse Events | Swelling : Grade >=3 | 1 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited Local Adverse Events | Pain : Total | 283 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited Local Adverse Events | Pain : Grade >=2 | 152 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited Local Adverse Events | Pain : Grade >=3 | 53 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited Local Adverse Events | Erythema : Total | 211 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited Local Adverse Events | Erythema : Grade >=2 | 66 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited Local Adverse Events | Erythema : Grade >=3 | 3 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited Local Adverse Events | Swelling : Total | 180 Participants |
| Atopic Dermatitis Participants | Number of Participants With Solicited Local Adverse Events | Swelling : Grade >=2 | 45 Participants |
Secondary
Number of Unsolicited Non-serious Adverse Events: Intensity
Occurrence of unsolicited non-serious AEs by Intensity
Time frame: within 29 days after any vaccination
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Grade 1 | 298 events |
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Total | 432 events |
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Grade 4 | 0 events |
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Grade 2 | 108 events |
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Missing | 0 events |
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Grade 3 | 26 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Missing | 0 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Total | 538 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Grade 1 | 432 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Grade 2 | 86 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Grade 3 | 20 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Intensity | Grade 4 | 0 events |
Secondary
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Time frame: within 29 days after any vaccination
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | None | 142 events |
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | Unlikely | 117 events |
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | Possible | 76 events |
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | Probable | 59 events |
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | Definite | 38 events |
| Healthy Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | Total | 432 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | Definite | 79 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | None | 170 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | Probable | 92 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | Unlikely | 86 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | Total | 538 events |
| Atopic Dermatitis Participants | Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination | Possible | 111 events |
Secondary
Percentage of Participants With Seroconversion by ELISA
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.
Time frame: within 32 weeks
Population: Per Protocol Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Participants | Percentage of Participants With Seroconversion by ELISA | Week 4 | 85.4 percentage of subjects |
| Healthy Participants | Percentage of Participants With Seroconversion by ELISA | Week 8 | 98.4 percentage of subjects |
| Healthy Participants | Percentage of Participants With Seroconversion by ELISA | Week 6 | 98.5 percentage of subjects |
| Healthy Participants | Percentage of Participants With Seroconversion by ELISA | Week 32 | 68.1 percentage of subjects |
| Healthy Participants | Percentage of Participants With Seroconversion by ELISA | Week 1 | 12.5 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by ELISA | Week 32 | 75.0 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by ELISA | Week 1 | 22.9 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by ELISA | Week 4 | 85.4 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by ELISA | Week 6 | 97.3 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by ELISA | Week 8 | 97.1 percentage of subjects |
Secondary
Percentage of Participants With Seroconversion by PRNT
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.
Time frame: within 32 weeks
Population: Per Protocol Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Participants | Percentage of Participants With Seroconversion by PRNT | Week 4 | 24.5 percentage of subjects |
| Healthy Participants | Percentage of Participants With Seroconversion by PRNT | Week 8 | 76.1 percentage of subjects |
| Healthy Participants | Percentage of Participants With Seroconversion by PRNT | Week 6 | 86.6 percentage of subjects |
| Healthy Participants | Percentage of Participants With Seroconversion by PRNT | Week 32 | 22.3 percentage of subjects |
| Healthy Participants | Percentage of Participants With Seroconversion by PRNT | Week 1 | 5.4 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by PRNT | Week 32 | 19.7 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by PRNT | Week 1 | 5.6 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by PRNT | Week 4 | 26.8 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by PRNT | Week 6 | 90.3 percentage of subjects |
| Atopic Dermatitis Participants | Percentage of Participants With Seroconversion by PRNT | Week 8 | 80.7 percentage of subjects |
Secondary
PRNT GMT
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'.
Time frame: within 32 weeks
Population: Per Protocol Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Healthy Participants | PRNT GMT | Week 0 | 1.1 Titer |
| Healthy Participants | PRNT GMT | Week 1 | 1.3 Titer |
| Healthy Participants | PRNT GMT | Week 4 | 2.4 Titer |
| Healthy Participants | PRNT GMT | Week 6 | 34.6 Titer |
| Healthy Participants | PRNT GMT | Week 8 | 15.7 Titer |
| Healthy Participants | PRNT GMT | Week 32 | 2.2 Titer |
| Atopic Dermatitis Participants | PRNT GMT | Week 8 | 21.9 Titer |
| Atopic Dermatitis Participants | PRNT GMT | Week 0 | 1.2 Titer |
| Atopic Dermatitis Participants | PRNT GMT | Week 6 | 47.7 Titer |
| Atopic Dermatitis Participants | PRNT GMT | Week 1 | 1.5 Titer |
| Atopic Dermatitis Participants | PRNT GMT | Week 32 | 2.3 Titer |
| Atopic Dermatitis Participants | PRNT GMT | Week 4 | 2.8 Titer |