A Phase 2 interventional study of IMVAMUNE in Atopic Dermatitis, sponsored by Bavarian Nordic. Completed at 22 sites in 2 countries. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by Bavarian Nordic · Phase 2, Interventional, and Prevention
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 632 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic 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.
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:
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
Biological: IMVAMUNE
Vaccinia naive subjects with diagnosed Atopic Dermatitis. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] \<= 30), receiving two doses of MVA-BN (IMVAMUNE)
Biological: IMVAMUNE
Subjects receiving two subcutaneous vaccinations
Also known as: MVA-BN
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
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
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
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
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
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
Number of Participants With SAEs
Occurrence, relationship and intensity of any serious AE (SAE)
Time frame: within 32 weeks
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
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
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
Number of Unsolicited Non-serious Adverse Events: Intensity
Occurrence of unsolicited non-serious AEs by Intensity
Time frame: within 29 days after any vaccination
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
| Milestone | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Started | 282 | 350 |
| Completed | 272 | 325 |
| Not completed | 10 | 25 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Subject unwilling/unable to comply with | 3 | 17 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Other | 3 | 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.
| percentage of subjects | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Percentage of Participants With Seroconversion by ELISA | 98.5 (95.5 to 99.7) | 97.3 (94.5 to 98.9) |
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.
| percentage of subjects | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Week 1 | 12.5 (8.1 to 18.2) | 22.9 (17.8 to 28.6) |
| Week 4 | 85.4 (79.6 to 90.1) | 85.4 (80.5 to 89.5) |
| Week 6 | 98.5 (95.5 to 99.7) | 97.3 (94.5 to 98.9) |
| Week 8 | 98.4 (95.4 to 99.7) | 97.1 (94.2 to 98.8) |
| Week 32 | 68.1 (57.7 to 77.3) | 75.0 (63.7 to 84.2) |
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'.
| Titer | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Week 0 | 1.4 (1.2 to 1.7) | 1.7 (1.4 to 2.0) |
| Week 1 | 2.2 (1.7 to 2.9) | 3.4 (2.6 to 4.4) |
| Week 4 | 60.0 (47.2 to 76.4) | 62.3 (50.1 to 77.4) |
| Week 6 | 499.4 (417.1 to 598.0) | 532.9 (452.9 to 627.1) |
| Week 8 | 298.0 (252.3 to 351.8) | 314.3 (269.2 to 366.8) |
| Week 32 | 21.4 (14.2 to 32.3) | 33.2 (21.7 to 50.6) |
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.
| percentage of subjects | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Week 1 | 5.4 (2.6 to 9.8) | 5.6 (3.1 to 9.3) |
| Week 4 | 24.5 (18.6 to 31.2) | 26.8 (21.4 to 32.7) |
| Week 6 | 86.6 (81.0 to 91.1) | 90.3 (86.0 to 93.6) |
| Week 8 | 76.1 (69.3 to 82.0) | 80.7 (75.2 to 85.5) |
| Week 32 | 22.3 (14.4 to 32.1) | 19.7 (11.5 to 30.5) |
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'.
| Titer | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Week 0 | 1.1 (1.0 to 1.2) | 1.2 (1.1 to 1.4) |
| Week 1 | 1.3 (1.1 to 1.5) | 1.5 (1.2 to 1.7) |
| Week 4 | 2.4 (1.9 to 3.1) | 2.8 (2.2 to 3.5) |
| Week 6 | 34.6 (26.4 to 45.3) | 47.7 (38.1 to 59.8) |
| Week 8 | 15.7 (12.0 to 20.6) | 21.9 (17.2 to 27.9) |
| Week 32 | 2.2 (1.6 to 2.9) | 2.3 (1.6 to 3.5) |
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
| Spot Forming Units / 10^6 PBMC | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Week 0 | 107.5 (0 to 775) | 109.0 (0 to 871) |
| Week 1 | 106.5 (0 to 674) | 166.0 (0 to 1800) |
| Week 6 | 276.5 (0 to 1800) | 334.0 (0 to 1800) |
Occurrence, relationship and intensity of any serious AE (SAE)
| Participants | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Any SAE | 3 | 3 |
| Any SAE with intensity >= Grade 3 | 3 | 2 |
| Any SAE assessed as related to vaccine | 1 | 0 |
Number of Participants with any Grade \>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.
| Participants | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Number of Participants With Related Grade >=3 Adverse Events | 16 | 27 |
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.
| Participants | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Pain : Total | 233 | 283 |
| Pain : Grade >=2 | 117 | 152 |
| Pain : Grade >=3 | 31 | 53 |
| Erythema : Total | 139 | 211 |
| Erythema : Grade >=2 | 35 | 66 |
| Erythema : Grade >=3 | 3 | 3 |
| Swelling : Total | 115 | 180 |
| Swelling : Grade >=2 | 21 | 45 |
| Swelling : Grade >=3 | 2 | 1 |
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.
| Participants | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Body Temperature increased : Total | 23 | 28 |
| Body Temperature increased : Related | 16 | 20 |
| Body Temperature increased : Grade >=3 | 1 | 1 |
| Body Temperature increased : Related - Grade >=3 | 1 | 1 |
| Headache : Total | 98 | 163 |
| Headache : Related | 76 | 119 |
| Headache : Grade >=3 | 9 | 26 |
| Headache : Related - Grade >=3 | 5 | 18 |
| Myalgia : Total | 98 | 153 |
| Myalgia : Related | 88 | 121 |
| Myalgia : Grade >=3 | 9 | 14 |
| Myalgia : Related - Grade >=3 | 8 | 9 |
| Chills : Total | 22 | 55 |
| Chills : Related | 19 | 39 |
| Chills : Grade >=3 | 4 | 7 |
| Chills : Related - Grade >=3 | 4 | 3 |
| Nausea : Total | 41 | 80 |
| Nausea : Related | 29 | 49 |
| Nausea : Grade >=3 | 6 | 8 |
| Nausea : Related - Grade >=3 | 4 | 5 |
| Fatigue : Total | 75 | 124 |
| Fatigue : Related | 53 | 90 |
| Fatigue : Grade >=3 | 9 | 16 |
| Fatigue : Related - Grade >=3 | 5 | 9 |
Occurrence of unsolicited non-serious AEs by Intensity
| events | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Total | 432 | 538 |
| Grade 1 | 298 | 432 |
| Grade 2 | 108 | 86 |
| Grade 3 | 26 | 20 |
| Grade 4 | 0 | 0 |
| Missing | 0 | 0 |
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
| events | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| None | 142 | 170 |
| Unlikely | 117 | 86 |
| Possible | 76 | 111 |
| Probable | 59 | 92 |
| Definite | 38 | 79 |
| Total | 432 | 538 |
Collected over 32 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Participants | 0/282 (0%) | 3/282 (1.1%) | 133/282 (47.2%) |
| Atopic Dermatitis Participants | 0/350 (0%) | 3/350 (0.9%) | 196/350 (56%) |
| Event | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Extraocular muscle paresisEye disorders | 1/282 | 0/350 |
| Head injuryInjury, poisoning and procedural complications | 1/282 | 0/350 |
| Loss of consciousnessInjury, poisoning and procedural complications | 1/282 | 0/350 |
| Panic attackPsychiatric disorders | 1/282 | 0/350 |
| NeurosisPsychiatric disorders | 0/282 | 1/350 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/282 | 1/350 |
| PneumoniaInfections and infestations | 0/282 | 1/350 |
| Event | Healthy Participants | Atopic Dermatitis Participants |
|---|---|---|
| Injection site pruritusGeneral disorders | 48/282 | 100/350 |
| Troponin I increasedInvestigations | 37/282 | 54/350 |
| HeadacheNervous system disorders | 19/282 | 16/350 |
| NasopharyngitisInfections and infestations | 11/282 | 23/350 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 0/282 | 15/350 |
| Upper respiratory tract infectionInfections and infestations | 9/282 | 6/350 |
| PharyngitisInfections and infestations | 9/282 | 4/350 |
| InfluenzaInfections and infestations | 8/282 | 11/350 |
| DizzinessNervous system disorders | 7/282 | 11/350 |
| CoughRespiratory, thoracic and mediastinal disorders | 8/282 | 3/350 |
Safety Analysis Set
| Age, Continuous(years) | Healthy Participants | Atopic Dermatitis Participants | Total |
|---|---|---|---|
| Mean | 27.4 ± 5.81 | 27.9 ± 6.33 | 27.7 ± 6.11 |
| Sex: Female, Male(Participants) | Healthy Participants | Atopic Dermatitis Participants | Total |
|---|---|---|---|
| Female | 150 | 223 | 373 |
| Male | 132 | 127 | 259 |
| Race/Ethnicity, Customized(Participants) | Healthy Participants | Atopic Dermatitis Participants | Total |
|---|---|---|---|
| Black | 24 | 33 | 57 |
| Caucasian | 124 | 125 | 249 |
| Hispanic | 109 | 134 | 243 |
| Oriental/Asian | 20 | 49 | 69 |
| Other | 5 | 9 | 14 |
| Region of Enrollment(Participants) | Healthy Participants | Atopic Dermatitis Participants | Total |
|---|---|---|---|
| United States | 194 | 243 | 437 |
| Mexico | 88 | 107 | 195 |
The record gives a start of Jul 2006, a primary completion of Nov 2009 and a completion of Apr 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 9 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: MVA-BN smallpox vaccine