Vaccination
Conditions
Brief summary
Prophylactic smallpox vaccination for personnel actively working with or in the vicinity of replicating vaccinia virus
Interventions
BIOLOGICALIMVAMUNE®
IMVAMUNE® liquid -frozen, containing 1 x 10E8 TCID50 MVA-BN® per 0.5 mL dose
Sponsors
Bavarian Nordic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects, aged 18-65 years, who will work with or in the vicinity of a replicating vaccinia virus and who volunteer for the program. Subjects may be vaccinia-naïve or vaccinia-experienced. * Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 48 hours prior to vaccination. * WOCBP must have used an acceptable method of contraception for at least 30 days prior to the first vaccination and must agree to use an acceptable method of contraception during the vaccination period until at least 28 days after the last vaccination. A woman is considered of child-bearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to barrier contraceptives which include Food and Drug Administration (FDA)-approved spermicides, intrauterine contraceptive devices, or licensed hormonal products.) * Read, signed and dated Informed Consent Form.
Exclusion criteria
* Pregnant or breast-feeding women. * Uncontrolled serious infection i.e., not responding to antimicrobial therapy. * History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. * Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; uncontrolled diabetes mellitus; moderate to severe kidney impairment or post organ transplant subjects. * History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. * History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor. * History of allergies or reactions to eggs, egg products, or gentamycin. * Having received any vaccinations or planned vaccinations with a live vaccine within 28 days or a killed vaccine within 14 days prior to or after IMVAMUNE®vaccination. * Chronic administration (defined as more than 6 days) of systemic corticosteroids within 30 days of the first planned vaccination. * Use of any investigational or non-registered drug or vaccine other than IMVAMUNE® within 30 days preceding the first vaccine dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ELISA Seropositivity Rate | up to Week 7 | Seropositivity rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seropositivity is defined as antibody titers ≥ detection limit (50). Percentages based on number of subjects with data available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ELISA Seroconversion Rate | Week 7 | 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 the Screening titer for initially seropositive subjects. Percentages based on number of subjects with data available. |
| ELISA GMT | up to Week 7 | 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'. |
| Serious Adverse Events | up to 32 weeks | Incidence, relationship and intensity of any Serious Adverse Event (SAE). |
| Related Grade >=3 Adverse Events | within 29 days after any vaccination | Incidence of any Grade \>=3 Adverse Events possibly, probably or definitely related to the trial vaccine |
| Non-serious AEs | within 29 days after any vaccination | Incidence of non-serious AEs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MVA-BN Two s.c. vaccinations with 0.5 ml MVA-BN® vaccine containing 1 x 10E8 TCID50 / dose | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | MVA-BN |
|---|---|
| Age, Continuous | 34.36 years STANDARD_DEVIATION 8.83 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 19 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
ELISA Seropositivity Rate
Seropositivity rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seropositivity is defined as antibody titers ≥ detection limit (50). Percentages based on number of subjects with data available.
Time frame: up to Week 7
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MVA-BN | ELISA Seropositivity Rate | Screening | 40.9 percentage of subjects |
| MVA-BN | ELISA Seropositivity Rate | Week 7 | 100.0 percentage of subjects |
Secondary
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: up to Week 7
Population: Full Analysis Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MVA-BN | ELISA GMT | Screening | 370.08 Titer |
| MVA-BN | ELISA GMT | Week 7 | 14961.54 Titer |
Secondary
ELISA Seroconversion Rate
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 the Screening titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time frame: Week 7
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MVA-BN | ELISA Seroconversion Rate | 90.9 percentage of subjects |
Secondary
Non-serious AEs
Incidence of non-serious AEs
Time frame: within 29 days after any vaccination
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVA-BN | Non-serious AEs | 19 Participants |
Secondary
Related Grade >=3 Adverse Events
Incidence of any Grade \>=3 Adverse Events possibly, probably or definitely related to the trial vaccine
Time frame: within 29 days after any vaccination
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVA-BN | Related Grade >=3 Adverse Events | 1 Participants |
Secondary
Serious Adverse Events
Incidence, relationship and intensity of any Serious Adverse Event (SAE).
Time frame: up to 32 weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVA-BN | Serious Adverse Events | 0 Participants |