Smallpox
Conditions
Keywords
Smallpox, Vaccination, Prevention
Brief summary
The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects. In addition the study further investigates the cardiac safety profile of MVA-BN® in a healthy population compared to placebo.
Detailed description
The study consists of 4 groups, which receive either MVA-BN once, MVA-BN two times, MVA-BN followed by placebo, or two administrations of placebo.
Interventions
BIOLOGICALMVA-BN® (IMVAMUNE)
1x 10E8\_TCID50
BIOLOGICALPlacebo
Tris-Buffer
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Bavarian Nordic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female subjects between 18 and 55 years of age. 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. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products.) 4. Lab values without clinically significant findings 5. Electrocardiogram (ECG) without abnormal findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV-node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, 2 premature ventricular contractions (PVC) in a row, ST elevation consistent with ischemia). Groups 1, 2 and 3 (All vaccinia-naïve subjects) additionally: 1. No history of known or suspected previous smallpox vaccination. 2. No detectable vaccinia scar. Group 4 (All previously vaccinated subjects) additionally: 1. History of previous smallpox vaccination (documented and/or typical vaccinia scar). 2. Most recent smallpox vaccination ≥ 5 years.
Exclusion criteria
1. Uncontrolled serious infection i.e. not responding to antimicrobial therapy. 2. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. 3. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment. 4. 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. 5. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor. 6. History of an immediate family member (father, mother, brother, or sister) who died due to ischemic heart disease before age 50 years. 7. 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. 8. History of anaphylaxis or severe allergic reaction. 9. Immune modulatory therapy. 10. History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject. 11. History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion by ELISA | 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4) | Seroconversion rate based on vaccinia-specific 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 ECG Changes | within 2 weeks after each vaccination | Occurrence of any specific or unspecific ECG change. Assessments at Screening (SCR), Visit 2 (Week 2) and Visit 4 (Week 6). |
| Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | within 32 weeks | Occurrence and relationship of any other cardiac symptom at any time during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events | within 8 days after any vaccination | Number of participants with solicited local AEs (pain, erythema, swelling and induration) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card. |
| Number of Participants With Solicited General Adverse Events | within 8 days after any vaccination | Number of participants with solicited systemic/general AEs (body temperature increased, headache, myalgia, nausea, and fatigue) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card. |
| Percentage of Participants With Seroconversion by ELISA | 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4) | Seroconversion rate based on vaccinia-specific 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 Unsolicited Non-serious Adverse Events | within 4 weeks after any vaccination | Number of participants with non-serious unsolicited AEs within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). |
| Number of Participants With Related Grade>=3 Adverse Events | within 4 weeks after any vaccination | Number of participants with any Grade \>=3 AE probably, possibly, or definitely related to the study vaccine within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Pooled solicited (local and general) and unsolicited AEs. |
| Percentage of Participants With Seroconversion by PRNT | 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4) | Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) 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 Related Serious Adverse Events | within 32 weeks | Number of participants with any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: 2x MVA-BN® s.c., Vaccinia Naive vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50) | 183 |
| Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one vaccination Placebo (0.5mL Tris Buffer) | 181 |
| Group 3: 2x Placebo, s.c., Vaccinia Naive vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer)
Placebo: Tris-Buffer | 181 |
| Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50) | 200 |
| Total | 745 |
Baseline characteristics
| Characteristic | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Total | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive |
|---|---|---|---|---|---|
| Age, Continuous | 25.3 years STANDARD_DEVIATION 4.98 | 29.8 years STANDARD_DEVIATION 9.07 | 41.5 years STANDARD_DEVIATION 7.59 | 26.0 years STANDARD_DEVIATION 5.1 | 25.4 years STANDARD_DEVIATION 4.38 |
| Race/Ethnicity, Customized Ethnic group Arabic | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnic group Asian | 1 Participants | 4 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnic group Black | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnic group Caucasian | 178 Participants | 729 Participants | 198 Participants | 177 Participants | 176 Participants |
| Race/Ethnicity, Customized Ethnic group Other | 2 Participants | 6 Participants | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment Germany | 183 participants | 745 participants | 200 participants | 181 participants | 181 participants |
| Sex: Female, Male Female | 97 Participants | 431 Participants | 115 Participants | 107 Participants | 112 Participants |
| Sex: Female, Male Male | 86 Participants | 314 Participants | 85 Participants | 74 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 183 | 0 / 181 | 0 / 181 | 0 / 200 |
| other Total, other adverse events | 91 / 183 | 88 / 181 | 54 / 181 | 73 / 200 |
| serious Total, serious adverse events | 3 / 183 | 3 / 181 | 5 / 181 | 1 / 200 |
Outcome results
Primary
Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI])
Occurrence and relationship of any other cardiac symptom at any time during the study
Time frame: within 32 weeks
Population: Safety dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Sinus tachycardia : unrelated | 1 events |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Tachycardia : related | 0 events |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Palpitations : unrelated | 1 events |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Palpitations : related | 0 events |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Mild pericardial effusion : unrelated | 0 events |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Tachycardia : unrelated | 1 events |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Mild pericardial effusion : related | 0 events |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Sinus tachycardia : related | 0 events |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Mild pericardial effusion : unrelated | 0 events |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Palpitations : related | 1 events |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Palpitations : unrelated | 1 events |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Sinus tachycardia : unrelated | 1 events |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Sinus tachycardia : related | 0 events |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Tachycardia : related | 1 events |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Mild pericardial effusion : related | 0 events |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Tachycardia : unrelated | 0 events |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Palpitations : unrelated | 1 events |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Mild pericardial effusion : related | 0 events |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Sinus tachycardia : unrelated | 0 events |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Mild pericardial effusion : unrelated | 0 events |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Tachycardia : related | 0 events |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Sinus tachycardia : related | 0 events |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Tachycardia : unrelated | 0 events |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Palpitations : related | 0 events |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Tachycardia : unrelated | 1 events |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Sinus tachycardia : related | 0 events |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Sinus tachycardia : unrelated | 0 events |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Tachycardia : related | 1 events |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Mild pericardial effusion : unrelated | 1 events |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Palpitations : related | 2 events |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Palpitations : unrelated | 3 events |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Mild pericardial effusion : related | 0 events |
Primary
Number of Participants With ECG Changes
Occurrence of any specific or unspecific ECG change. Assessments at Screening (SCR), Visit 2 (Week 2) and Visit 4 (Week 6).
Time frame: within 2 weeks after each vaccination
Population: Safety dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Repolarisation | 2 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Supraventricular arrhytmia | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Low voltage | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : T inversion - pathological | 42 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Right bundle branch block - incomplete | 10 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Other non-specific changes | 34 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Bradycardia | 31 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Tall T-waves | 1 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : AV block (PQ time >0.20 sec) 1st degree | 2 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Arrhythmia | 4 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Ventricular arrhythmia | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Repolarisation | 1 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Other non-specific changes | 35 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : T inversion - other | 14 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Q-Abnormalities | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Supraventricular arrhytmia | 1 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Tall T-waves | 1 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : AV block (PQ time >0.20 sec) 1st degree | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Arrhythmia | 4 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Low voltage | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Other non-specific changes | 23 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Bradycardia | 30 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Bradycardia | 30 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Arrhythmia | 4 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Right bundle branch block - incomplete | 10 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Repolarisation | 3 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Low voltage | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Q-Abnormalities | 1 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Ventricular arrhythmia | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Tall T-waves | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Q-Abnormalities | 1 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : T inversion - other | 3 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Supraventricular arrhytmia | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : ST elevation | 5 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Ventricular arrhythmia | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : T inversion - pathological | 28 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : AV block (PQ time >0.20 sec) 1st degree | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Right bundle branch block - incomplete | 9 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : ST depression | 1 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : ST elevation | 3 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : ST depression | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : ST depression | 0 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : ST elevation | 1 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : T inversion - pathological | 34 participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : T inversion - other | 11 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Arrhythmia | 3 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : AV block (PQ time >0.20 sec) 1st degree | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Low voltage | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Low voltage | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Ventricular arrhythmia | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Repolarisation | 3 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Right bundle branch block - incomplete | 18 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Other non-specific changes | 29 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : T inversion - pathological | 54 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : AV block (PQ time >0.20 sec) 1st degree | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : ST depression | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Bradycardia | 25 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : ST depression | 1 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Q-Abnormalities | 1 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Right bundle branch block - incomplete | 17 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Arrhythmia | 4 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Ventricular arrhythmia | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Arrhythmia | 4 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : T inversion - other | 5 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Repolarisation | 3 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Repolarisation | 3 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Tall T-waves | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Right bundle branch block - incomplete | 20 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Supraventricular arrhytmia | 1 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : T inversion - other | 9 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Q-Abnormalities | 3 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : T inversion - other | 19 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : ST elevation | 1 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Supraventricular arrhytmia | 1 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Tall T-waves | 3 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : T inversion - pathological | 46 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : T inversion - pathological | 37 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : ST elevation | 3 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Low voltage | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : AV block (PQ time >0.20 sec) 1st degree | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Bradycardia | 23 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Ventricular arrhythmia | 1 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Other non-specific changes | 23 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Tall T-waves | 1 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : ST elevation | 1 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Supraventricular arrhytmia | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Bradycardia | 28 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Q-Abnormalities | 0 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Other non-specific changes | 35 participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : ST depression | 1 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Low voltage | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Supraventricular arrhytmia | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Ventricular arrhythmia | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : AV block (PQ time >0.20 sec) 1st degree | 1 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Right bundle branch block - incomplete | 4 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : ST elevation | 4 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : ST depression | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : T inversion - pathological | 50 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : T inversion - other | 22 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Low voltage | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Other non-specific changes | 26 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Bradycardia | 30 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Arrhythmia | 8 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Repolarisation | 3 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Q-Abnormalities | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | SCR : Tall T-waves | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Supraventricular arrhytmia | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Ventricular arrhythmia | 1 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : AV block (PQ time >0.20 sec) 1st degree | 1 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Right bundle branch block - incomplete | 15 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : ST elevation | 2 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : ST depression | 1 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : T inversion - pathological | 40 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : T inversion - other | 10 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Low voltage | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Other non-specific changes | 34 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Bradycardia | 33 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Arrhythmia | 2 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Repolarisation | 2 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Q-Abnormalities | 1 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 2 : Tall T-waves | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Supraventricular arrhytmia | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Ventricular arrhythmia | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : AV block (PQ time >0.20 sec) 1st degree | 1 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Right bundle branch block - incomplete | 12 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : ST elevation | 1 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : ST depression | 0 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : T inversion - pathological | 39 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : T inversion - other | 4 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Other non-specific changes | 33 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Bradycardia | 28 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Arrhythmia | 2 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Repolarisation | 7 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Q-Abnormalities | 1 participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With ECG Changes | Week 6 : Tall T-waves | 2 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : T inversion - other | 7 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : T inversion - pathological | 31 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : ST elevation | 1 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : Right bundle branch block - incomplete | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : ST depression | 1 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : ST elevation | 0 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : Supraventricular arrhytmia | 0 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : ST elevation | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : Right bundle branch block - incomplete | 15 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : AV block (PQ time >0.20 sec) 1st degree | 1 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : Repolarisation | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : ST depression | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : Ventricular arrhythmia | 0 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : Supraventricular arrhytmia | 0 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : Right bundle branch block - incomplete | 1 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : T inversion - pathological | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : Tall T-waves | 0 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : Q-Abnormalities | 4 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : AV block (PQ time >0.20 sec) 1st degree | 1 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : T inversion - other | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : Repolarisation | 0 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : Arrhythmia | 1 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : Bradycardia | 6 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : Tall T-waves | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : Other non-specific changes | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : Other non-specific changes | 5 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : Low voltage | 1 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : Q-Abnormalities | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : Bradycardia | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : T inversion - other | 16 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : T inversion - pathological | 48 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : Tall T-waves | 0 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : Q-Abnormalities | 4 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : Repolarisation | 1 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : Ventricular arrhythmia | 0 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : Supraventricular arrhytmia | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : Arrhythmia | 5 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : Low voltage | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : Arrhythmia | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : Ventricular arrhythmia | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : Bradycardia | 6 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : Other non-specific changes | 14 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | SCR : ST depression | 1 participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 6 : AV block (PQ time >0.20 sec) 1st degree | NA participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With ECG Changes | Week 2 : Low voltage | 0 participants |
Primary
Percentage of Participants With Seroconversion by ELISA
Seroconversion rate based on vaccinia-specific 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: 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by ELISA | 98.9 percentage of subjects |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by ELISA | 82.2 percentage of subjects |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by ELISA | 3.4 percentage of subjects |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Percentage of Participants With Seroconversion by ELISA | 95.5 percentage of subjects |
Secondary
Number of Participants With Related Grade>=3 Adverse Events
Number of participants with any Grade \>=3 AE probably, possibly, or definitely related to the study vaccine within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Pooled solicited (local and general) and unsolicited AEs.
Time frame: within 4 weeks after any vaccination
Population: Safety dataset
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Related Grade>=3 Adverse Events | 10 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Related Grade>=3 Adverse Events | 5 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Related Grade>=3 Adverse Events | 5 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Related Grade>=3 Adverse Events | 15 Participants |
Secondary
Number of Participants With Related Serious Adverse Events
Number of participants with any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study
Time frame: within 32 weeks
Population: Safety dataset
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Related Serious Adverse Events | 1 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Related Serious Adverse Events | 0 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Related Serious Adverse Events | 0 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Related Serious Adverse Events | 0 Participants |
Secondary
Number of Participants With Solicited General Adverse Events
Number of participants with solicited systemic/general AEs (body temperature increased, headache, myalgia, nausea, and fatigue) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card.
Time frame: within 8 days after any vaccination
Population: Safety dataset
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Myalgia | 29 Participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Body temperature increased | 18 Participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Nausea | 17 Participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Headache | 60 Participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Fatigue | 68 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Myalgia | 22 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Headache | 84 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Nausea | 22 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Body temperature increased | 21 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Fatigue | 59 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Fatigue | 55 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Body temperature increased | 10 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Headache | 49 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Myalgia | 20 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited General Adverse Events | Nausea | 13 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Solicited General Adverse Events | Fatigue | 78 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Solicited General Adverse Events | Nausea | 18 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Solicited General Adverse Events | Headache | 53 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Solicited General Adverse Events | Body temperature increased | 10 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Solicited General Adverse Events | Myalgia | 42 Participants |
Secondary
Number of Participants With Solicited Local Adverse Events
Number of participants with solicited local AEs (pain, erythema, swelling and induration) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card.
Time frame: within 8 days after any vaccination
Population: Safety dataset
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site pain | 166 Participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site erythema | 166 Participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site swelling | 149 Participants |
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site induration | 162 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site erythema | 146 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site swelling | 103 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site induration | 146 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site pain | 155 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site swelling | 10 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site erythema | 39 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site induration | 5 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Solicited Local Adverse Events | Injection site pain | 37 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Solicited Local Adverse Events | Injection site induration | 155 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Solicited Local Adverse Events | Injection site erythema | 169 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Solicited Local Adverse Events | Injection site pain | 167 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Solicited Local Adverse Events | Injection site swelling | 149 Participants |
Secondary
Number of Participants With Unsolicited Non-serious Adverse Events
Number of participants with non-serious unsolicited AEs within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0).
Time frame: within 4 weeks after any vaccination
Population: Safety dataset
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Number of Participants With Unsolicited Non-serious Adverse Events | 113 Participants |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Number of Participants With Unsolicited Non-serious Adverse Events | 106 Participants |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Number of Participants With Unsolicited Non-serious Adverse Events | 78 Participants |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Number of Participants With Unsolicited Non-serious Adverse Events | 99 Participants |
Secondary
Percentage of Participants With Seroconversion by ELISA
Seroconversion rate based on vaccinia-specific 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: 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4)
Population: Full Analysis Set (includes subjects with data available 4 weeks following the last vaccination)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by ELISA | 98.9 percentage of subjects |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by ELISA | 72.0 percentage of subjects |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by ELISA | 2.8 percentage of subjects |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Percentage of Participants With Seroconversion by ELISA | 93.0 percentage of subjects |
Secondary
Percentage of Participants With Seroconversion by PRNT
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) 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: 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4)
Population: Full Analysis Set (includes subjects with data available 4 weeks following the last vaccination)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by PRNT | 86.0 percentage of subjects |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by PRNT | 47.4 percentage of subjects |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by PRNT | 0.0 percentage of subjects |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Percentage of Participants With Seroconversion by PRNT | 69.8 percentage of subjects |
Secondary
Percentage of Participants With Seroconversion by PRNT
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) 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: 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by PRNT | 89.2 percentage of subjects |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by PRNT | 56.3 percentage of subjects |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | Percentage of Participants With Seroconversion by PRNT | 0.0 percentage of subjects |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | Percentage of Participants With Seroconversion by PRNT | 78.5 percentage of subjects |