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Trial record 70 of 154 for:    Dermatitis, Atopic, 8

Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00723489
Recruitment Status : Completed
First Posted : July 28, 2008
Results First Posted : September 30, 2013
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Atopic Dermatitis
Interventions Biological: Live Yellow Fever Vaccine (YFV-17D)
Drug: YFV-17D Placebo
Enrollment 82
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title YFV-17D SC - (Non-AD) YFV-17D SC - (AD) YFV-17D TC - (Non-AD) YFV-17D TC - (AD)
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 21 19 19 23
Completed 20 [1] 15 [1] 19 [1] 20 [1]
Not Completed 1 4 0 3
Reason Not Completed
Physician Decision             0             1             0             0
Pregnancy             0             0             0             1
Withdrawal by Subject             0             0             0             1
Seropositive at baseline             1             0             0             0
Prohibited Medication             0             0             0             1
Samples Collected Out of Window             0             3             0             0
[1]
Includes seroconverters and non-seroconverters
Arm/Group Title YFV-17D SC - (Non-AD) YFV-17D SC - (AD) YFV-17D TC - (Non-AD) YFV-17D TC - (AD) Total
Hide Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 20 15 19 20 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 15 participants 19 participants 20 participants 74 participants
32.0  (4.5) 34.7  (6.2) 33.9  (4.7) 32.8  (4.3) 33.3  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 15 participants 19 participants 20 participants 74 participants
Female
12
  60.0%
8
  53.3%
10
  52.6%
12
  60.0%
42
  56.8%
Male
8
  40.0%
7
  46.7%
9
  47.4%
8
  40.0%
32
  43.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 15 participants 19 participants 20 participants 74 participants
20 15 19 20 74
Total Serum Immunoglobulin E (IgE; kU/L)   [1] 
Mean (Standard Deviation)
Unit of measure:  kU/L
Number Analyzed 20 participants 15 participants 19 participants 20 participants 74 participants
35.4  (40.3) 1166.4  (3609.5) 73.6  (115.7) 2742.1  (8262.5) 1006.0  (4646.1)
[1]
Measure Description: 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.
Percent Eosinophils in Blood   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent Eosinophils
Number Analyzed 20 participants 15 participants 19 participants 20 participants 74 participants
2.6  (1.9) 3.7  (2.1) 2.4  (2.0) 3.8  (3.2) 3.1  (2.4)
[1]
Measure Description: 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%.
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study; and seroconverted
Arm/Group Title YFV-17D TC - (AD) YFV-17D TC - (Non-AD)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: LNI
1.8  (0.4) 1.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection YFV-17D TC - (AD), YFV-17D TC - (Non-AD)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.3 to 0.2
Estimation Comments Mean (AD) – Mean (Non-AD)
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame 30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study; and seroconverted
Arm/Group Title YFV-17D SC - (AD) YFV-17D SC - (Non-AD)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 20
Mean (Standard Deviation)
Unit of Measure: Log10 Neutralization Index (LNI)
1.8  (0.3) 1.8  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection YFV-17D SC - (AD), YFV-17D SC - (Non-AD)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.2 to 0.2
Estimation Comments Mean (AD) – Mean (Non-AD)
3.Primary Outcome
Title 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
Hide Description 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.
Time Frame 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study; and seroconverted
Arm/Group Title YFV-17D TC - (AD) YFV-17D TC - (Non-AD)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 14
Mean (Standard Deviation)
Unit of Measure: Log10 (NT50)
3.5  (0.4) 3.8  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection YFV-17D TC - (AD), YFV-17D TC - (Non-AD)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.05
Estimation Comments Mean (AD) – Mean (Non-AD)
4.Primary Outcome
Title 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
Hide Description 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.
Time Frame 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study; and seroconverted
Arm/Group Title YFV-17D SC - (AD) YFV-17D SC - (Non-AD)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 20
Mean (Standard Deviation)
Unit of Measure: Log10 (NT50)
3.6  (0.4) 3.5  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection YFV-17D SC - (AD), YFV-17D SC - (Non-AD)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.3
Estimation Comments Mean (AD) – Mean (Non-AD)
5.Secondary Outcome
Title Comparison of Count of Seroconverters: YFV-17D TC– (AD) Participants Compared to YFV-17D TC – (Non-AD) Participants
Hide Description 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.
Time Frame Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study; seroconverters as well as non-seroconverters
Arm/Group Title YFV-17D TC - (AD) YFV-17D TC - (Non-AD)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: participants
Did not seroconvert 2 5
Seroconverted 18 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection YFV-17D TC - (AD), YFV-17D TC - (Non-AD)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments P-value is not adjusted for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Comparison of Count of Seroconverters: YFV-17D SC – (AD) Participants Compared to YFV-17D SC – (Non-AD) Participants
Hide Description 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.
Time Frame Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study; seroconverters as well as non-seroconverters
Arm/Group Title YFV-17D SC - (AD) YFV-17D SC - (Non-AD)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 15 20
Measure Type: Number
Unit of Measure: participants
Did not seroconvert 1 0
Seroconverted 14 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection YFV-17D SC - (AD), YFV-17D SC - (Non-AD)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments P-value is not adjusted for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title 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
Hide Description 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).
Time Frame Day 30 (Day 28-35)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title YFV-17D SC - (AD) YFV-17D SC - (Non-AD)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 13 16
Mean (Standard Deviation)
Unit of Measure: Log10 cell count/10^6 cells
2.8  (0.4) 2.7  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection YFV-17D SC - (AD), YFV-17D SC - (Non-AD)
Comments This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC –(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments P-value is not adjusted for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values) Day 30
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.1 to 0.3
Estimation Comments Mean (AD) – Mean (Non-AD)
8.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 30 (Day 28-35)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title YFV-17D TC - (AD) YFV-17D TC - (Non-AD)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: Log10 cell count/10^6 cells
2.5  (0.3) 2.7  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection YFV-17D TC - (AD), YFV-17D TC - (Non-AD)
Comments 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
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments P-value is not adjusted for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values) Day 30
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.5 to -0.02
Estimation Comments Mean (AD) – Mean (Non-AD)
9.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 30 (Day 28-35)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title YFV-17D SC - (AD) YFV-17D SC - (Non-AD)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 13 16
Mean (Standard Deviation)
Unit of Measure: Log10 cell count/10^6 cells
3.4  (0.3) 3.3  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection YFV-17D SC - (AD), YFV-17D SC - (Non-AD)
Comments This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC –(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments P-value is not adjusted for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values) Day 30
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.3 to 0.4
Estimation Comments Mean (AD) – Mean (Non-AD)
10.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 30 (Day 28-35)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title YFV-17D TC - (AD) YFV-17D TC - (Non-AD)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 11
Mean (Standard Deviation)
Unit of Measure: Log10 cell count/10^6 cells
3.0  (0.5) 3.3  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection YFV-17D TC - (AD), YFV-17D TC - (Non-AD)
Comments 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
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments P-value is not adjusted for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values) Day 30
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.7 to -0.01
Estimation Comments Mean (AD) – Mean (Non-AD)
Time Frame [Not Specified]
Adverse Event Reporting Description 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)
 
Arm/Group Title YFV-17D SC - (Non-AD) YFV-17D SC - (AD) YFV-17D TC - (Non-AD) YFV-17D TC - (AD)
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
YFV-17D SC - (Non-AD) YFV-17D SC - (AD) YFV-17D TC - (Non-AD) YFV-17D TC - (AD)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
YFV-17D SC - (Non-AD) YFV-17D SC - (AD) YFV-17D TC - (Non-AD) YFV-17D TC - (AD)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/19 (0.00%)      0/19 (0.00%)      0/23 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
YFV-17D SC - (Non-AD) YFV-17D SC - (AD) YFV-17D TC - (Non-AD) YFV-17D TC - (AD)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/21 (95.24%)      19/19 (100.00%)      18/19 (94.74%)      21/23 (91.30%)    
Blood and lymphatic system disorders         
Lymphadenopathy  1  0/21 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1 3/23 (13.04%)  3
Gastrointestinal disorders         
Nausea  1  1/21 (4.76%)  1 4/19 (21.05%)  4 0/19 (0.00%)  0 3/23 (13.04%)  3
General disorders         
Application site pain  1  0/21 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1 3/23 (13.04%)  3
Fatigue  1  3/21 (14.29%)  3 7/19 (36.84%)  9 0/19 (0.00%)  0 7/23 (30.43%)  8
Injection site pain  1  4/21 (19.05%)  4 2/19 (10.53%)  3 0/19 (0.00%)  0 1/23 (4.35%)  1
Infections and infestations         
Upper respiratory tract infection  1  0/21 (0.00%)  0 3/19 (15.79%)  3 0/19 (0.00%)  0 3/23 (13.04%)  3
Investigations         
Alanine aminotransferase increased  1  2/21 (9.52%)  2 3/19 (15.79%)  3 1/19 (5.26%)  1 1/23 (4.35%)  1
Aspartate aminotransferase increased  1  0/21 (0.00%)  0 2/19 (10.53%)  2 2/19 (10.53%)  2 2/23 (8.70%)  2
Blood cholesterol increased  1  4/21 (19.05%)  4 5/19 (26.32%)  6 4/19 (21.05%)  5 3/23 (13.04%)  3
Blood glucose decreased  1  3/21 (14.29%)  3 3/19 (15.79%)  3 3/19 (15.79%)  3 2/23 (8.70%)  2
Blood glucose increased  1  2/21 (9.52%)  2 1/19 (5.26%)  1 4/19 (21.05%)  5 5/23 (21.74%)  5
Blood magnesium decreased  1  5/21 (23.81%)  5 2/19 (10.53%)  3 9/19 (47.37%)  11 4/23 (17.39%)  5
Haemoglobin decreased  1  3/21 (14.29%)  3 3/19 (15.79%)  3 1/19 (5.26%)  1 1/23 (4.35%)  1
Lymph node palpable  1  2/21 (9.52%)  2 1/19 (5.26%)  1 0/19 (0.00%)  0 2/23 (8.70%)  2
Lymphocyte count decreased  1  2/21 (9.52%)  2 4/19 (21.05%)  4 3/19 (15.79%)  3 5/23 (21.74%)  5
Neutrophil count decreased  1  9/21 (42.86%)  9 5/19 (26.32%)  5 5/19 (26.32%)  6 5/23 (21.74%)  5
White blood cell count decreased  1  2/21 (9.52%)  2 3/19 (15.79%)  3 4/19 (21.05%)  4 3/23 (13.04%)  3
Metabolism and nutrition disorders         
Hyperglycaemia  1  3/21 (14.29%)  4 2/19 (10.53%)  2 5/19 (26.32%)  6 2/23 (8.70%)  3
Hypokalaemia  1  3/21 (14.29%)  3 2/19 (10.53%)  2 3/19 (15.79%)  4 1/23 (4.35%)  1
Hypomagnesaemia  1  8/21 (38.10%)  11 4/19 (21.05%)  5 2/19 (10.53%)  2 6/23 (26.09%)  7
Hypophosphataemia  1  1/21 (4.76%)  1 2/19 (10.53%)  2 2/19 (10.53%)  2 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  3/21 (14.29%)  3 4/19 (21.05%)  4 0/19 (0.00%)  0 2/23 (8.70%)  2
Back pain  1  1/21 (4.76%)  1 3/19 (15.79%)  3 1/19 (5.26%)  1 5/23 (21.74%)  6
Myalgia  1  3/21 (14.29%)  3 4/19 (21.05%)  4 0/19 (0.00%)  0 2/23 (8.70%)  3
Nervous system disorders         
Headache  1  1/21 (4.76%)  1 5/19 (26.32%)  6 0/19 (0.00%)  0 4/23 (17.39%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Associate Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00723489     History of Changes
Other Study ID Numbers: DAIT ADVN YF08
HHSN266200400029C
First Submitted: July 25, 2008
First Posted: July 28, 2008
Results First Submitted: July 16, 2013
Results First Posted: September 30, 2013
Last Update Posted: January 13, 2014