Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | healthy, vaccinia naïve subjects 2 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous |
|
| Group 2 | Active Comparator | healthy, vaccinia naïve subjects 5 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous |
|
| Group 3 | Active Comparator | healthy, vaccinia naïve subjects 1 x 10E8 TCID50 IMVAMUNE (MVA-BN), subcutaneous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMVAMUNE (MVA-BN) | Biological | Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rolf Pokorny, M.D. | Swiss Pharma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Pharma Contract | Basel | 4123 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19944151 | Result | von Krempelhuber A, Vollmar J, Pokorny R, Rapp P, Wulff N, Petzold B, Handley A, Mateo L, Siersbol H, Kollaritsch H, Chaplin P. A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE. Vaccine. 2010 Feb 3;28(5):1209-16. doi: 10.1016/j.vaccine.2009.11.030. Epub 2009 Nov 25. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012899 | Smallpox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C527606 | smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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'. | 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. | 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'. | Days 28, 42, 84 |
| Cytotoxic T-Lymphocyte response | The Cytotoxic T-Lymphocyte (CTL) response was determined by measuring IFNγ producing cells by Intracellular cytokine staining (ICS) | Days 28, 42, 84 |
| Serious Adverse Events | Incidence, relationship and intensity of any Serious Adverse Event (SAE) | 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. | 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. | within 8 days after any vaccination |
| Unsolicited Non-serious Adverse Events | Occurrence of unsolicited non-serious AEs: Intensity and relationship to vaccination | within 31 days after any vaccination |