Respiratory Syncytial Virus Infections
Conditions
Keywords
RSV Vaccines, Respiratory Syncytial Virus Vaccines
Brief summary
A total of 63 subjects will be recruited into three groups (18 subjects per group will receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen suspension of MVA BN RSV. Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per 0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.
Interventions
BIOLOGICALMVA BN RSV
Liquid frozen suspension of MVA-mBN294B
OTHERPlacebo
Tris Buffered Saline, sterile
Sponsors
Bavarian Nordic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* signed and dated an informed consent form * Body mass index ≥ 18.5 and \< 35. * Women of childbearing potential (WOCBP) must have used an acceptable method of contraception
Exclusion criteria
* Pregnant or breast-feeding women. * Uncontrolled serious infection, i.e. not responding to antimicrobial therapy. * History of any serious medical condition. * History of or active autoimmune disease. * Known or suspected impairment of immunologic functions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solicited general adverse events | day of vaccination and the following seven days | Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events |
| Occurrence of grade 3 adverse events | Screening up to week 8 after first vaccination | Occurrence of any grade 3 or higher adverse events possibly, probably or definitely related to the trial vaccine within four weeks after each vaccination. |
| Solicited local adverse events | day of vaccination and the following seven days | Occurrence, intensity and duration of solicited local adverse events after each vaccination Occurrence, intensity and duration of solicited local adverse events after each vaccination Occurrence, intensity and duration of solicited local adverse events after each vaccination |
| Unsolicited non-serious adverse events | within four weeks after each vaccination | Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events |
| Occurrence of serious adverse events | Screening up to week 34 after first vaccination | Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSV-specific humoral immune response | humoral immune response is measured up to week 34 | To assess the RSV-specific serum antibody responses by ELISA |
| Vaccinica-specific humoral immune response | humoral immune response is measured up to week 34 | To assess the Vaccinica-specific serum antibody responses by ELISA |
| Vaccinia-specific cellular immune responses. | cellular immune response measured up to week 4 after 2nd vaccination | To assess the RSV-specific and vaccinia-specific cellular immune responses against the MVA-BN RSV vaccine in healthy adult subjects. Spot forming units will be determined by using an IFN-γ ELISPOT assay. |
Countries
United States
Outcome results
None listed