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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN266200400029C |
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The main objective of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) is to reduce the risk of the fatal reaction, eczema vaccinatum (EV), to the smallpox vaccination in those with atopic dermatitis (AD). Since vaccination with live vaccinia virus (VV) in individuals with AD increases the risk of EV, a yellow fever vaccine was chosen. The purpose of this study is to determine the immune response to a yellow fever vaccine in adults with AD.
AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. The purpose of this study is to understand the immune response to a yellow fever vaccine in adults with AD. This study will provide substantial information about normal and defective cutaneous immunity in participants with AD in response to a live virus vaccine, which is critical for understanding the EV reaction.
An individual's participation in the study will last up to 13 weeks. Participants will be randomized into one of two arms. The first experimental arm will consist of 20 adults with AD and 20 healthy adults. They will receive one dose of YFV-17D by subcutaneous administration in the right deltoid and receive one dose of YFV-17D placebo by transcutaneous administration in the left deltoid. The second arm will consist of 20 adults with AD and 20 healthy adults. They will receive one dose of YFV-17D placebo by subcutaneous administration in the right deltoid and receive one dose of YFV-17D vaccine transcutaneously in the left deltoid.
This study will consist of 6 follow-up visits over a 35 day period after study entry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YFV-17D (Right Deltoid) | Experimental | Participants will be randomized within each atopic dermatitis (AD) severity subgroup or as non-atopic controls to either subcutaneous (SC) or transcutaneous (TC) vaccine administration. In this arm, participants will receive a standard vaccine dose (5.5x10^4 Plaque Forming Units) of YFV-17D administered subcutaneously in the right deltoid and placebo vaccination transcutaneously (then covered with a semi-occlusive dressing) in the left deltoid. The site pharmacist will maintain the blind and an unblinded (i.e., masked) site coordinator will administer assigned treatment: investigators, participants and assessors remain blinded to treatment assignments throughout the duration of the trial. |
|
| YFV-17D (Left Deltoid) | Experimental | Participants will be randomized within each atopic dermatitis (AD) severity subgroup or as non-atopic controls to either subcutaneous (SC) or transcutaneous (TC) vaccination. In this arm, participants will receive YFV-17D vaccination (1x10^3 Plaque Forming Units) by transcutaneous administration (then covered with a semi-occlusive dressing to optimize YFV-17D absorption) in the left deltoid and placebo by subcutaneous administration in the right deltoid. The site pharmacist will maintain the blind and an unblinded (i.e., masked) site coordinator will administered treatment: investigators, participants and assessors remain blinded to treatment assignments throughout the duration of the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Yellow Fever Vaccine (YFV-17D) | Biological |
| ||
| YFV-17D Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D TC- (AD) Participants Compared to YFV-17D TC- (Non-AD) Participants | Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus. | 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) |
| Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D SC - (AD) Participants Compared to YFV-17D SC- (Non-AD) Participants | Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus. | 30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization) |
| Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D TC - (AD) Participants Compared to YFV-17D TC - (Non - AD) Participants | Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus. | 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) |
| Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants | Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Count of Seroconverters: YFV-17D TC- (AD) Participants Compared to YFV-17D TC - (Non-AD) Participants | Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus. | Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Hanifin, M.D. | Oregon Health and Science University | Study Chair |
| Mark Slifka, Ph.D. | Oregon Health and Science University | Principal Investigator |
| Eric Simpson, M.D. | Oregon Health and Science University | Principal Investigator |
| Henry Milgrom, M.D. | National Jewish Health | Principal Investigator |
| Richard Gallo, M.D., Ph.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92037 | United States | ||
| National Jewish Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24331381 | Derived | Slifka MK, Leung DY, Hammarlund E, Raue HP, Simpson EL, Tofte S, Baig-Lewis S, David G, Lynn H, Woolson R, Hata T, Milgrom H, Hanifin J. Transcutaneous yellow fever vaccination of subjects with or without atopic dermatitis. J Allergy Clin Immunol. 2014 Feb;133(2):439-47. doi: 10.1016/j.jaci.2013.10.037. Epub 2013 Dec 10. |
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From August 2008 to March 2011, three centers in the United States recruited participants ages 27 to 43 years who fulfilled eligibility criteria. Refer to the Eligibility Section for more details.
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| ID | Title | Description |
|---|---|---|
| FG000 | YFV-17D SC - (Non-AD) | Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid. |
| FG001 | YFV-17D SC - (AD) | Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid. |
| FG002 | YFV-17D TC - (Non-AD) | Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid. |
| FG003 | YFV-17D TC - (AD) | Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | YFV-17D SC - (Non-AD) | Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D TC- (AD) Participants Compared to YFV-17D TC- (Non-AD) Participants | Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus. | All participants who completed the study; and seroconverted | Posted | Mean | Standard Deviation | LNI | 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) |
|
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This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | YFV-17D SC - (Non-AD) | Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Drug |
|
| 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) |
| Comparison of Count of Seroconverters: YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants | Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus. | Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35) |
| Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD4 Positive T-cells, YFV-17D SC - (AD) Compared to YFV-17D SC - (Non- AD) Participants | Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD4 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T-cells on Day 30 (acceptable blood draw window: Day 28 - 35). | Day 30 (Day 28-35) |
| Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive , CD4 Positive T-cells, YFV-17D TC - (AD) Compared to YFV-17D TC - (Non-AD) Participants | Comparison by designated reporting groups: the Log10 transformed count of CD4 Positive T-cells that express IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T- Cells (Day 30). A higher count reflects a better immune response to Yellow Fever virus. | Day 30 (Day 28-35) |
| Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D SC -(AD) Compared to YFV-17D SC - (Non-AD) Participants | Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells. | Day 30 (Day 28-35) |
| Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D TC - (AD) Compared to YFV-17D TC - (Non-AD) Participants | Comparison by designated reporting groups: the Log10 transformed count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells. | Day 30 (Day 28-35) |
| Denver |
| Colorado |
| 80206 |
| United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Pregnancy |
|
| Withdrawal by Subject |
|
| Seropositive at baseline |
|
| Prohibited Medication |
|
| Samples Collected Out of Window |
|
| BG001 | YFV-17D SC - (AD) | Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid. |
| BG002 | YFV-17D TC - (Non-AD) | Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid. |
| BG003 | YFV-17D TC - (AD) | Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total Serum Immunoglobulin E (IgE; kU/L) | Total amount of IgE in the blood, which is a measurement of allergen sensitization. Higher IgE is indicative of greater allergen sensitization. There is no "normal" level for total serum IgE since a wide overlap exists between the total serum IgE in healthy non-allergic and allergic individuals. | Mean | Standard Deviation | kU/L |
|
| Percent Eosinophils in Blood | Eosinophils are a type of immune cell that has granules (small particles) with enzymes that are released during infections, allergic reactions, and asthma. An eosinophil is a type of white blood cell. Normal Reference Range: 0.0% - 7.0%. | Mean | Standard Deviation | Percent Eosinophils |
|
| OG001 | YFV-17D TC - (Non-AD) | Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid. |
|
|
|
| Primary | Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D SC - (AD) Participants Compared to YFV-17D SC- (Non-AD) Participants | Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus. | All participants who completed the study; and seroconverted | Posted | Mean | Standard Deviation | Log10 Neutralization Index (LNI) | 30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization) |
|
|
|
|
| Primary | Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D TC - (AD) Participants Compared to YFV-17D TC - (Non - AD) Participants | Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus. | All participants who completed the study; and seroconverted | Posted | Mean | Standard Deviation | Log10 (NT50) | 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) |
|
|
|
|
| Primary | Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants | Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus. | All participants who completed the study; and seroconverted | Posted | Mean | Standard Deviation | Log10 (NT50) | 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) |
|
|
|
|
| Secondary | Comparison of Count of Seroconverters: YFV-17D TC- (AD) Participants Compared to YFV-17D TC - (Non-AD) Participants | Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus. | Includes all participants who completed the study; seroconverters as well as non-seroconverters | Posted | Number | participants | Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35) |
|
|
|
|
| Secondary | Comparison of Count of Seroconverters: YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants | Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus. | Includes all participants who completed the study; seroconverters as well as non-seroconverters | Posted | Number | participants | Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35) |
|
|
|
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| Secondary | Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD4 Positive T-cells, YFV-17D SC - (AD) Compared to YFV-17D SC - (Non- AD) Participants | Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD4 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T-cells on Day 30 (acceptable blood draw window: Day 28 - 35). | Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(Non-AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing | Posted | Mean | Standard Deviation | Log10 cell count/10^6 cells | Day 30 (Day 28-35) |
|
|
|
|
| Secondary | Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive , CD4 Positive T-cells, YFV-17D TC - (AD) Compared to YFV-17D TC - (Non-AD) Participants | Comparison by designated reporting groups: the Log10 transformed count of CD4 Positive T-cells that express IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T- Cells (Day 30). A higher count reflects a better immune response to Yellow Fever virus. | Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing | Posted | Mean | Standard Deviation | Log10 cell count/10^6 cells | Day 30 (Day 28-35) |
|
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|
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| Secondary | Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D SC -(AD) Compared to YFV-17D SC - (Non-AD) Participants | Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells. | Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing | Posted | Mean | Standard Deviation | Log10 cell count/10^6 cells | Day 30 (Day 28-35) |
|
|
|
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| Secondary | Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D TC - (AD) Compared to YFV-17D TC - (Non-AD) Participants | Comparison by designated reporting groups: the Log10 transformed count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells. | Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing | Posted | Mean | Standard Deviation | Log10 cell count/10^6 cells | Day 30 (Day 28-35) |
|
|
|
|
| 0 |
| 21 |
| 20 |
| 21 |
| EG001 | YFV-17D SC - (AD) | Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid. | 0 | 19 | 19 | 19 |
| EG002 | YFV-17D TC - (Non-AD) | Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid. | 0 | 19 | 18 | 19 |
| EG003 | YFV-17D TC - (AD) | Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid. | 0 | 23 | 21 | 23 |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Application site pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Lymph node palpable | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |