Atopic Dermatitis
Conditions
Keywords
Yellow Fever Vaccine, Scarification Method, Atopic Dermatitis, IgG antibodies
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALLive Yellow Fever Vaccine (YFV-17D)
DRUGYFV-17D Placebo
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
27 Years to 43 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of Atopic Dermatitis or Non-atopic control * Born and currently residing in the United States * Weight of at least 110 lbs at the Screening Visit * Not previously vaccinated for YFV, tick-borne encephalitis (TBEV), Japanese encephalitis virus (JEV), or dengue fever * Agree to use adequate contraception 30 days prior to and until their participation in the study is completed. More information on this criterion can be found in the protocol.
Exclusion criteria
* AD subjects with exfoliative erythroderma or lacking a minimum 10 cm diameter area of normal appearing skin on the deltoid or thigh vaccination sites * Have a body mass index (BMI) of 30 or greater at the Screening Visit * Known history of infection with YFV, dengue fever, TBEV, JEV, or West Nile Virus (WNV) * A family history of severe reactions to the yellow fever vaccine * Traveled to Africa or South America (including participants who plan to travel to these areas prior to completion of the study) * History of egg allergy or have a positive egg allergy skin prick test that is administered at the Screening visit * History of acute hypersensitivity reaction to any components of the yellow fever vaccine (including gelatin) * Have latex allergy * Have lidocaine allergy * Are allergic or hypersensitive to TegadermTM * Received systemic immunosuppressants within 30 days prior to receiving the vaccination * Received systemic corticosteroids, anti inflammatory biologics (e.g., alefacept, etanercept, etc.), or calcineurin inhibitors within 30 days prior to receiving the vaccination * Received systemic antibiotics or antivirals within 7 days of receiving the vaccination * Received greater than 440 mcg of inhaled steroids per day within 6 months prior to receiving the vaccination * Received Xolair (Omalizumab) within 1 year prior to receiving the vaccination * Received immunotherapy within 30 days prior to receiving the vaccination * Received any vaccine within 30 days prior to randomization or expected receipt 30 days after randomization * Received topical antibiotics, antivirals, immune enhancers (e.g., imiquimod), or calcineurin inhibitors within 7 days prior to receiving the vaccination * Received topical corticosteroids within 7 days prior to receiving the vaccination * Received phototherapy (e.g., ultraviolet light B \[UVB\], psoralen plus ultraviolet light A \[PUVA\]) within 30 days prior to receiving the vaccination * Acute febrile illness or active fungal, bacterial, or viral infections (subjects may be reconsidered for enrollment once the condition has resolved) * Skin disease other than AD that might compromise the stratum corneum barrier (e.g., clinically evident ichthyosis, bullous disease, psoriasis) * Current or past history of malignancy or of autoimmune or immunodeficiency diseases. More information on this criterion can be found in the protocol. * Pregnant or breastfeeding * Have an anti-nuclear antibody (ANA) titer that is equal to or greater than 1/160 at the Screening Visit * Have a serum immunoglobulin (Ig)G, IgM, IgA, C3, or C4 level below the normal range at the Screening Visit * Have a manual lymphocyte count that is less than 1000 lymphocytes per microliter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) | 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. |
| 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 | 30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization) | 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. |
| 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 | 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) | 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. |
| 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 | 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 30 (Day 28-35) | 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. |
| Comparison of Count of Seroconverters: YFV-17D TC- (AD) Participants Compared to YFV-17D TC - (Non-AD) Participants | Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35) | 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. |
| 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 | Day 30 (Day 28-35) | 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. |
| Comparison of Count of Seroconverters: YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants | Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35) | 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. |
| 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 | Day 30 (Day 28-35) | 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). |
| 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 | Day 30 (Day 28-35) | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 15 |
| 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. | 19 |
| 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. | 20 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 |
| Overall Study | Pregnancy | 0 | 0 | 0 | 1 |
| Overall Study | Prohibited Medication | 0 | 0 | 0 | 1 |
| Overall Study | Samples Collected Out of Window | 0 | 3 | 0 | 0 |
| Overall Study | Seropositive at baseline | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | YFV-17D SC - (Non-AD) | YFV-17D SC - (AD) | YFV-17D TC - (Non-AD) | YFV-17D TC - (AD) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 32.0 years STANDARD_DEVIATION 4.5 | 34.7 years STANDARD_DEVIATION 6.2 | 33.9 years STANDARD_DEVIATION 4.7 | 32.8 years STANDARD_DEVIATION 4.3 | 33.3 years STANDARD_DEVIATION 4.9 |
| Percent Eosinophils in Blood | 2.6 Percent Eosinophils STANDARD_DEVIATION 1.9 | 3.7 Percent Eosinophils STANDARD_DEVIATION 2.1 | 2.4 Percent Eosinophils STANDARD_DEVIATION 2 | 3.8 Percent Eosinophils STANDARD_DEVIATION 3.2 | 3.1 Percent Eosinophils STANDARD_DEVIATION 2.4 |
| Region of Enrollment United States | 20 participants | 15 participants | 19 participants | 20 participants | 74 participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 10 Participants | 12 Participants | 42 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 9 Participants | 8 Participants | 32 Participants |
| Total Serum Immunoglobulin E (IgE; kU/L) | 35.4 kU/L STANDARD_DEVIATION 40.3 | 1166.4 kU/L STANDARD_DEVIATION 3609.5 | 73.6 kU/L STANDARD_DEVIATION 115.7 | 2742.1 kU/L STANDARD_DEVIATION 8262.5 | 1006.0 kU/L STANDARD_DEVIATION 4646.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 21 | 19 / 19 | 18 / 19 | 21 / 23 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 | 0 / 19 | 0 / 23 |
Outcome results
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.
Time frame: 30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization)
Population: All participants who completed the study; and seroconverted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| YFV-17D TC - (AD) | 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 | 1.8 Log10 Neutralization Index (LNI) | Standard Deviation 0.3 |
| YFV-17D TC - (Non-AD) | 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 | 1.8 Log10 Neutralization Index (LNI) | Standard Deviation 0.3 |
p-value: 0.8695% CI: [-0.2, 0.2]ANOVA
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.
Time frame: 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)
Population: All participants who completed the study; and seroconverted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| YFV-17D TC - (AD) | 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 | 1.8 LNI | Standard Deviation 0.4 |
| YFV-17D TC - (Non-AD) | 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 | 1.8 LNI | Standard Deviation 0.4 |
p-value: 0.8695% CI: [-0.3, 0.2]ANOVA
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.
Time frame: 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)
Population: All participants who completed the study; and seroconverted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| YFV-17D TC - (AD) | 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 | 3.6 Log10 (NT50) | Standard Deviation 0.4 |
| YFV-17D TC - (Non-AD) | 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 | 3.5 Log10 (NT50) | Standard Deviation 0.3 |
p-value: 0.6695% CI: [-0.2, 0.3]ANOVA
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.
Time frame: 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)
Population: All participants who completed the study; and seroconverted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| YFV-17D TC - (AD) | 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 | 3.5 Log10 (NT50) | Standard Deviation 0.4 |
| YFV-17D TC - (Non-AD) | 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 | 3.8 Log10 (NT50) | Standard Deviation 0.3 |
p-value: 0.195% CI: [-0.5, 0.05]ANOVA
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).
Time frame: Day 30 (Day 28-35)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| YFV-17D TC - (AD) | 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 | 2.8 Log10 cell count/10^6 cells | Standard Deviation 0.4 |
| YFV-17D TC - (Non-AD) | 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 | 2.7 Log10 cell count/10^6 cells | Standard Deviation 0.3 |
Comparison: 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 processingp-value: 0.4895% CI: [-0.1, 0.3]Mixed Models Analysis
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.
Time frame: Day 30 (Day 28-35)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| YFV-17D TC - (AD) | 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 | 2.5 Log10 cell count/10^6 cells | Standard Deviation 0.3 |
| YFV-17D TC - (Non-AD) | 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 | 2.7 Log10 cell count/10^6 cells | Standard Deviation 0.2 |
Comparison: 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 processingp-value: 0.03695% CI: [-0.5, -0.02]Mixed Models Analysis
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.
Time frame: Day 30 (Day 28-35)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| YFV-17D TC - (AD) | 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 | 3.4 Log10 cell count/10^6 cells | Standard Deviation 0.3 |
| YFV-17D TC - (Non-AD) | 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 | 3.3 Log10 cell count/10^6 cells | Standard Deviation 0.4 |
Comparison: 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 processingp-value: 0.8295% CI: [-0.3, 0.4]Mixed Models Analysis
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.
Time frame: Day 30 (Day 28-35)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| YFV-17D TC - (AD) | 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 | 3.0 Log10 cell count/10^6 cells | Standard Deviation 0.5 |
| YFV-17D TC - (Non-AD) | 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 | 3.3 Log10 cell count/10^6 cells | Standard Deviation 0.5 |
Comparison: 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 processingp-value: 0.04595% CI: [-0.7, -0.01]Mixed Models Analysis
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.
Time frame: Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)
Population: Includes all participants who completed the study; seroconverters as well as non-seroconverters
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| YFV-17D TC - (AD) | Comparison of Count of Seroconverters: YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants | Did not seroconvert | 1 participants |
| YFV-17D TC - (AD) | Comparison of Count of Seroconverters: YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants | Seroconverted | 14 participants |
| YFV-17D TC - (Non-AD) | Comparison of Count of Seroconverters: YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants | Did not seroconvert | 0 participants |
| YFV-17D TC - (Non-AD) | Comparison of Count of Seroconverters: YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants | Seroconverted | 20 participants |
p-value: 0.43Fisher Exact
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.
Time frame: Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)
Population: Includes all participants who completed the study; seroconverters as well as non-seroconverters
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| YFV-17D TC - (AD) | Comparison of Count of Seroconverters: YFV-17D TC- (AD) Participants Compared to YFV-17D TC - (Non-AD) Participants | Did not seroconvert | 2 participants |
| YFV-17D TC - (AD) | Comparison of Count of Seroconverters: YFV-17D TC- (AD) Participants Compared to YFV-17D TC - (Non-AD) Participants | Seroconverted | 18 participants |
| YFV-17D TC - (Non-AD) | Comparison of Count of Seroconverters: YFV-17D TC- (AD) Participants Compared to YFV-17D TC - (Non-AD) Participants | Did not seroconvert | 5 participants |
| YFV-17D TC - (Non-AD) | Comparison of Count of Seroconverters: YFV-17D TC- (AD) Participants Compared to YFV-17D TC - (Non-AD) Participants | Seroconverted | 14 participants |
p-value: 0.24Fisher Exact