Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Biological: MVA BN RSVOther: Placebo
- Registration Number
- NCT02419391
- Lead Sponsor
- Bavarian Nordic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Placebo 18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo Group 2 Placebo 18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo Group 2 MVA BN RSV 18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo Group 1 MVA BN RSV 18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo Group 3 MVA BN RSV 50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo Group 3 Placebo 50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo
- Primary Outcome Measures
Name Time Method 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).
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
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
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
- Secondary Outcome Measures
Name Time Method RSV-specific humoral immune response humoral immune response is measured up to week 34 To assess the RSV-specific mucosal 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.
Trial Locations
- Locations (1)
Johnson County Clin-Trials (JCCT)
🇺🇸Lenexa, Kansas, United States