Back to resultsTrial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MVA BN RSV
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring RSV Vaccines, Respiratory Syncytial Virus Vaccines
Eligibility Criteria
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.
Sites / Locations
- Johnson County Clin-Trials (JCCT)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo
18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo
50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo
Outcomes
Primary Outcome Measures
Occurrence of serious adverse events
Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).
Occurrence of grade 3 adverse events
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
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
Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events
Solicited general adverse events
Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events
Secondary Outcome Measures
Vaccinia-specific cellular immune responses.
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.
RSV-specific humoral immune response
To assess the RSV-specific serum antibody responses by ELISA
RSV-specific humoral immune response
To assess the RSV-specific serum antibody responses by PRNT
RSV-specific humoral immune response
To assess the RSV-specific mucosal antibody responses by ELISA
Vaccinica-specific humoral immune response
To assess the Vaccinica-specific serum antibody responses by ELISA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02419391
Brief Title
Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine
Official Title
A Randomized, Single-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bavarian Nordic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
RSV Vaccines, Respiratory Syncytial Virus Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo
Arm Title
Group 2
Arm Type
Experimental
Arm Description
18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo
Arm Title
Group 3
Arm Type
Experimental
Arm Description
50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo
Intervention Type
Biological
Intervention Name(s)
MVA BN RSV
Other Intervention Name(s)
MVA-mBN294B
Intervention Description
Liquid frozen suspension of MVA-mBN294B
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
TBS
Intervention Description
Tris Buffered Saline, sterile
Primary Outcome Measure Information:
Title
Occurrence of serious adverse events
Description
Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).
Time Frame
Screening up to week 34 after first vaccination
Title
Occurrence of grade 3 adverse events
Description
Occurrence of any grade 3 or higher adverse events possibly, probably or definitely related to the trial vaccine within four weeks after each vaccination.
Time Frame
Screening up to week 8 after first vaccination
Title
Solicited local adverse events
Description
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
Time Frame
day of vaccination and the following seven days
Title
Unsolicited non-serious adverse events
Description
Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events
Time Frame
within four weeks after each vaccination
Title
Solicited general adverse events
Description
Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events
Time Frame
day of vaccination and the following seven days
Secondary Outcome Measure Information:
Title
Vaccinia-specific cellular immune responses.
Description
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.
Time Frame
cellular immune response measured up to week 4 after 2nd vaccination
Title
RSV-specific humoral immune response
Description
To assess the RSV-specific serum antibody responses by ELISA
Time Frame
humoral immune response is measured up to week 34
Title
RSV-specific humoral immune response
Description
To assess the RSV-specific serum antibody responses by PRNT
Time Frame
humoral immune response is measured up to week 34
Title
RSV-specific humoral immune response
Description
To assess the RSV-specific mucosal antibody responses by ELISA
Time Frame
humoral immune response is measured up to week 34
Title
Vaccinica-specific humoral immune response
Description
To assess the Vaccinica-specific serum antibody responses by ELISA
Time Frame
humoral immune response is measured up to week 34
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casey Johnson, DO
Organizational Affiliation
Johnson County Clin-Trials (JCCT)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johnson County Clin-Trials (JCCT)
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine
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