Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00723489
First received: July 25, 2008
Last updated: December 11, 2013
Last verified: December 2013
Results First Received: July 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Atopic Dermatitis
Interventions: Biological: Live Yellow Fever Vaccine (YFV-17D)
Drug: YFV-17D Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.
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.
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.

Participant Flow:   Overall Study
    YFV-17D SC - (Non-AD)     YFV-17D SC - (AD)     YFV-17D TC - (Non-AD)     YFV-17D TC - (AD)  
STARTED     21     19     19     23  
COMPLETED     20 [1]   15 [1]   19 [1]   20 [1]
NOT COMPLETED     1     4     0     3  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
    YFV-17D SC - (Non-AD)     YFV-17D SC - (AD)     YFV-17D TC - (Non-AD)     YFV-17D TC - (AD)     Total  
Number of Participants  
[units: participants]
  20     15     19     20     74  
Age  
[units: years]
Mean ± Standard Deviation
  32.0  ± 4.5     34.7  ± 6.2     33.9  ± 4.7     32.8  ± 4.3     33.3  ± 4.9  
Gender  
[units: participants]
         
Female     12     8     10     12     42  
Male     8     7     9     8     32  
Region of Enrollment  
[units: participants]
         
United States     20     15     19     20     74  
Total Serum Immunoglobulin E (IgE; kU/L) [1]
[units: kU/L]
Mean ± Standard Deviation
  35.4  ± 40.3     1166.4  ± 3609.5     73.6  ± 115.7     2742.1  ± 8262.5     1006.0  ± 4646.1  
Percent Eosinophils in Blood [2]
[units: Percent Eosinophils]
Mean ± Standard Deviation
  2.6  ± 1.9     3.7  ± 2.1     2.4  ± 2.0     3.8  ± 3.2     3.1  ± 2.4  
[1] 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.
[2] 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%.



  Outcome Measures
  Show All Outcome Measures

1.  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   [ Time Frame: 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) ]

2.  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   [ Time Frame: 30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization) ]

3.  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   [ Time Frame: 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) ]

4.  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   [ Time Frame: 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) ]

5.  Secondary:   Comparison of Count of Seroconverters: YFV-17D TC– (AD) Participants Compared to YFV-17D TC – (Non-AD) Participants   [ Time Frame: Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35) ]

6.  Secondary:   Comparison of Count of Seroconverters: YFV-17D SC – (AD) Participants Compared to YFV-17D SC – (Non-AD) Participants   [ Time Frame: Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35) ]

7.  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   [ Time Frame: Day 30 (Day 28-35) ]

8.  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   [ Time Frame: Day 30 (Day 28-35) ]

9.  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   [ Time Frame: Day 30 (Day 28-35) ]

10.  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   [ Time Frame: Day 30 (Day 28-35) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Associate Director, Clinical Research Operations Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Publications automatically indexed to this study:

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
Study First Received: July 25, 2008
Results First Received: July 16, 2013
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration