The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
632
Subjects receiving two subcutaneous vaccinations
Alta Clinical Research LLC
Tucson, Arizona, United States
Percentage of Participants With Seroconversion by ELISA
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time frame: week 6
Percentage of Participants With Seroconversion by ELISA
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time frame: within 32 weeks
ELISA GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
Time frame: within 32 weeks
Percentage of Participants With Seroconversion by PRNT
Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time frame: within 32 weeks
PRNT GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Time frame: within 32 weeks
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Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Rx Clinical Research, Inc.
Garden Grove, California, United States
Solano Clinical Research
Vallejo, California, United States
Northwestern University
Chicago, Illinois, United States
Adult & Pediatric Dermatology PC
Overland Park, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Saint Louis University
St Louis, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research
Omaha, Nebraska, United States
...and 12 more locations
ELISPOT IFN-γ Values
Number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) per 10\^6 PBMC in response to restimulation with MVA-BN detected by ELISPOT assay
Time frame: within 6 weeks
Number of Participants With SAEs
Occurrence, relationship and intensity of any serious AE (SAE)
Time frame: within 32 weeks
Number of Participants With Related Grade >=3 Adverse Events
Number of Participants with any Grade \>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.
Time frame: within 29 days after vaccination
Number of Participants With Solicited Local Adverse Events
Number of Participants with and Intensity of solicited local AEs (erythema, swelling and pain). Percentages based on subjects with at least one completed diary card.
Time frame: within 8 days after any vaccination
Number of Participants With Solicited General AEs
Number of Participants with solicited systemic/general AEs (elevated body temperature, headache, myalgia, nausea, fatigue and chills): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Time frame: within 8 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Intensity
Occurrence of unsolicited non-serious AEs by Intensity
Time frame: within 29 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Time frame: within 29 days after any vaccination