A Phase 2 interventional study of MVA-BN® (IMVAMUNE) and Placebo in Smallpox, sponsored by Bavarian Nordic. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-06.
Sponsored by Bavarian Nordic · Phase 2, Interventional, and Prevention
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.
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.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 745 is above the median of 150 across 61 interventional studies indexed under Smallpox.
Browse Smallpox studies →Bavarian Nordic is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Groups 1, 2 and 3 (All vaccinia-naïve subjects) additionally:
Group 4 (All previously vaccinated subjects) additionally:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
vaccinia naive subjects receiving two subcutanenous vaccinations with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID)
Biological: MVA-BN® (IMVAMUNE)
vaccinica naive subjects receiving one vaccination with 0.5ml MVA-BN® IMVAMUNE(1x10E08 TCID), followed by one vaccination Placebo (0.5ml Tris Buffer)
Biological: MVA-BN® (IMVAMUNE) · Biological: Placebo
vaccinia naive subjects, receiving two subcutaneous vaccinations with Placebo (0.5ml Tris Buffer).
Biological: Placebo
vaccinia experienced subjects, receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID).
Biological: MVA-BN® (IMVAMUNE)
1x 10E8_TCID50
Tris-Buffer
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)
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
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
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)
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)
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)
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
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
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
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
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
| Milestone | Group 1: 2 x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: Two x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Started | 183 | 181 | 181 | 200 |
| Completed | 175 | 173 | 175 | 200 |
| Not completed | 8 | 8 | 6 | 0 |
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.
| percentage of subjects | GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | GP 3: Two x Placebo, s.c., Vaccinia Naive | GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Percentage of Participants With Seroconversion by ELISA | 98.9 (96.0 to 99.9) | 82.2 (75.7 to 87.6) | 3.4 (1.3 to 7.3) | 95.5 (91.6 to 97.9) |
Occurrence of any specific or unspecific ECG change. Assessments at Screening (SCR), Visit 2 (Week 2) and Visit 4 (Week 6).
| participants | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| SCR : Supraventricular arrhytmia | 0 | 0 | 0 | 0 |
| SCR : Ventricular arrhythmia | 0 | 0 | 0 | 0 |
| SCR : AV block (PQ time >0.20 sec) 1st degree | 0 | 0 | 1 | 1 |
| SCR : Right bundle branch block - incomplete | 10 | 18 | 4 | 1 |
| SCR : ST elevation | 5 | 1 | 4 | 1 |
| SCR : ST depression | 0 | 1 | 0 | 1 |
| SCR : T inversion - pathological | 42 | 54 | 50 | 48 |
| SCR : T inversion - other | 14 | 19 | 22 | 16 |
| SCR : Low voltage | 0 | 0 | 0 | 1 |
| SCR : Other non-specific changes | 23 | 23 | 26 | 5 |
| SCR : Bradycardia | 30 | 28 | 30 | 6 |
| SCR : Arrhythmia | 4 | 3 | 8 | 1 |
| SCR : Repolarisation | 3 | 3 | 3 | 0 |
| SCR : Q-Abnormalities | 1 | 1 | 0 | 4 |
| SCR : Tall T-waves | 0 | 0 | 0 | 0 |
| Week 2 : Supraventricular arrhytmia | 0 | 1 | 0 | 0 |
| Week 2 : Ventricular arrhythmia | 0 | 1 | 1 | 0 |
| Week 2 : AV block (PQ time >0.20 sec) 1st degree | 0 | 0 | 1 | 1 |
| Week 2 : Right bundle branch block - incomplete | 9 | 17 | 15 | 15 |
| Week 2 : ST elevation | 3 | 1 | 2 | 0 |
| Week 2 : ST depression | 0 | 1 | 1 | 1 |
| Week 2 : T inversion - pathological | 34 | 46 | 40 | 31 |
| Week 2 : T inversion - other | 11 | 9 | 10 | 7 |
| Week 2 : Low voltage | 0 | 0 | 0 | 0 |
| Week 2 : Other non-specific changes | 34 | 29 | 34 | 14 |
| Week 2 : Bradycardia | 31 | 25 | 33 | 6 |
| Week 2 : Arrhythmia | 4 | 4 | 2 | 5 |
| Week 2 : Repolarisation | 1 | 3 | 2 | 1 |
| Week 2 : Q-Abnormalities | 0 | 3 | 1 | 4 |
| Week 2 : Tall T-waves | 1 | 3 | 0 | 0 |
| Week 6 : Supraventricular arrhytmia | 1 | 1 | 0 | NA |
| Week 6 : Ventricular arrhythmia | 0 | 0 | 0 | NA |
| Week 6 : AV block (PQ time >0.20 sec) 1st degree | 2 | 0 | 1 | NA |
| Week 6 : Right bundle branch block - incomplete | 10 | 20 | 12 | NA |
| Week 6 : ST elevation | 1 | 3 | 1 | NA |
| Week 6 : ST depression | 1 | 0 | 0 | NA |
| Week 6 : T inversion - pathological | 28 | 37 | 39 | NA |
| Week 6 : T inversion - other | 3 | 5 | 4 | NA |
| Week 6 : Low voltage | 0 | 0 | 0 | NA |
| Week 6 : Other non-specific changes | 35 | 35 | 33 | NA |
| Week 6 : Bradycardia | 30 | 23 | 28 | NA |
| Week 6 : Arrhythmia | 4 | 4 | 2 | NA |
| Week 6 : Repolarisation | 2 | 3 | 7 | NA |
| Week 6 : Q-Abnormalities | 1 | 0 | 1 | NA |
| Week 6 : Tall T-waves | 1 | 1 | 2 | NA |
Occurrence and relationship of any other cardiac symptom at any time during the study
| events | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Sinus tachycardia : related | 0 | 0 | 0 | 0 |
| Sinus tachycardia : unrelated | 1 | 1 | 0 | 0 |
| Tachycardia : related | 0 | 1 | 0 | 1 |
| Tachycardia : unrelated | 1 | 0 | 0 | 1 |
| Palpitations : related | 0 | 1 | 0 | 2 |
| Palpitations : unrelated | 1 | 1 | 1 | 3 |
| Mild pericardial effusion : related | 0 | 0 | 0 | 0 |
| Mild pericardial effusion : unrelated | 0 | 0 | 0 | 1 |
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.
| percentage of subjects | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Percentage of Participants With Seroconversion by ELISA | 98.9 | 72.0 | 2.8 | 93.0 |
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.
| percentage of subjects | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Percentage of Participants With Seroconversion by PRNT | 89.2 | 56.3 | 0.0 | 78.5 |
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.
| percentage of subjects | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Percentage of Participants With Seroconversion by PRNT | 86.0 | 47.4 | 0.0 | 69.8 |
Number of participants with any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study
| Participants | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Number of Participants With Related Serious Adverse Events | 1 | 0 | 0 | 0 |
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.
| Participants | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Injection site pain | 166 | 155 | 37 | 167 |
| Injection site erythema | 166 | 146 | 39 | 169 |
| Injection site swelling | 149 | 103 | 10 | 149 |
| Injection site induration | 162 | 146 | 5 | 155 |
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.
| Participants | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Body temperature increased | 18 | 21 | 10 | 10 |
| Headache | 60 | 84 | 49 | 53 |
| Myalgia | 29 | 22 | 20 | 42 |
| Nausea | 17 | 22 | 13 | 18 |
| Fatigue | 68 | 59 | 55 | 78 |
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.
| Participants | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Number of Participants With Related Grade>=3 Adverse Events | 10 | 5 | 5 | 15 |
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).
| Participants | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Number of Participants With Unsolicited Non-serious Adverse Events | 113 | 106 | 78 | 99 |
Collected over 32 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | 0/183 (0%) | 3/183 (1.6%) | 91/183 (49.7%) |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | 0/181 (0%) | 3/181 (1.7%) | 88/181 (48.6%) |
| GP 3: Two x Placebo, s.c., Vaccinia Naive | 0/181 (0%) | 5/181 (2.8%) | 54/181 (29.8%) |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | 0/200 (0%) | 1/200 (0.5%) | 73/200 (36.5%) |
| Event | GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | GP 3: Two x Placebo, s.c., Vaccinia Naive | GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Gastroenteritis salmonellaInfections and infestations | 0/183 | 0/181 | 1/181 | 0/200 |
| Lower limb fractureInjury, poisoning and procedural complications | 0/183 | 0/181 | 1/181 | 0/200 |
| Tendon injuryInjury, poisoning and procedural complications | 0/183 | 1/181 | 0/181 | 0/200 |
| Thyroid cystEndocrine disorders | 0/183 | 0/181 | 1/181 | 0/200 |
| Benign neoplasm of thyroid glandNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/183 | 0/181 | 1/181 | 0/200 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/183 | 0/181 | 1/181 | 0/200 |
| HemiparesisNervous system disorders | 0/183 | 1/181 | 0/181 | 0/200 |
| PregnancyPregnancy, puerperium and perinatal conditions | 0/183 | 1/181 | 0/181 | 0/200 |
| DepressionPsychiatric disorders | 0/183 | 0/181 | 1/181 | 0/200 |
| ThyroidectomySurgical and medical procedures | 0/183 | 0/181 | 1/181 | 0/200 |
| Event | GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | GP 3: Two x Placebo, s.c., Vaccinia Naive | GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced |
|---|---|---|---|---|
| Injection site pruritusGeneral disorders | 43/183 | 36/181 | 4/181 | 49/200 |
| NasopharyngitisInfections and infestations | 42/183 | 20/181 | 26/181 | 4/200 |
| HeadacheNervous system disorders | 10/183 | 16/181 | 11/181 | 6/200 |
| Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders | 11/183 | 9/181 | 8/181 | 4/200 |
| Injection site hematomaGeneral disorders | 6/183 | 9/181 | 5/181 | 4/200 |
| Injection site warmthGeneral disorders | 9/183 | 5/181 | 0/181 | 8/200 |
| DizzinessNervous system disorders | 2/183 | 7/181 | 2/181 | 4/200 |
| DiarrhoeaGastrointestinal disorders | 3/183 | 4/181 | 3/181 | 6/200 |
| TonsilitisInfections and infestations | 4/183 | 5/181 | 1/181 | 0/200 |
| Back painMusculoskeletal and connective tissue disorders | 4/183 | 1/181 | 5/181 | 2/200 |
Safety Dataset
| Age, Continuous(years) | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced | Total |
|---|---|---|---|---|---|
| Mean | 25.3 ± 4.98 | 25.4 ± 4.38 | 26.0 ± 5.1 | 41.5 ± 7.59 | 29.8 ± 9.07 |
| Sex: Female, Male(Participants) | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced | Total |
|---|---|---|---|---|---|
| Female | 97 | 112 | 107 | 115 | 431 |
| Male | 86 | 69 | 74 | 85 | 314 |
| Race/Ethnicity, Customized(Participants) | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced | Total |
|---|---|---|---|---|---|
| Ethnic group — Caucasian | 178 | 176 | 177 | 198 | 729 |
| Ethnic group — Asian | 1 | 2 | 1 | 0 | 4 |
| Ethnic group — Black | 0 | 1 | 0 | 1 | 2 |
| Ethnic group — Arabic | 2 | 1 | 1 | 0 | 4 |
| Ethnic group — Other | 2 | 1 | 2 | 1 | 6 |
| Region of Enrollment(participants) | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | Group 3: 2x Placebo, s.c., Vaccinia Naive | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced | Total |
|---|---|---|---|---|---|
| Germany | 183 | 181 | 181 | 200 | 745 |
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