The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
165
Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.
Swiss Pharma Contract
Basel, Switzerland
ELISA seroconversion rate
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit 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: Day 42
ELISA seroconversion rate
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit 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: Days 28, 84
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: Days 28, 42, 84
PRNT seroconversion rate
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit 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: Days 28, 42, 84
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: Days 28, 42, 84
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Cytotoxic T-Lymphocyte response
The Cytotoxic T-Lymphocyte (CTL) response was determined by measuring IFNγ producing cells by Intracellular cytokine staining (ICS)
Time frame: Days 28, 42, 84
Serious Adverse Events
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
Time frame: within 12 weeks
Solicited Local Adverse Events
Incidence and intensity of solicited local AEs. Percentages based on subjects with at least one completed diary card.
Time frame: within 8 days after any vaccination
Solicited General Adverse Events
Incidence of solicited general AEs: Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Time frame: within 8 days after any vaccination
Unsolicited Non-serious Adverse Events
Occurrence of unsolicited non-serious AEs: Intensity and relationship to vaccination
Time frame: within 31 days after any vaccination