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RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MVA-BN-RSV
Placebo
Sponsored by
Bavarian Nordic
About
Eligibility
Locations
Arms
Outcomes
Full info

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

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • signed and dated an informed consent form and HIPAA.
  • Subjects without symptomatic cardiopulmonary and/or metabolic disease.
  • Body mass index (BMI) ≥ 18.5 and ≤ 34.9.
  • Negative human immunodeficiency virus antibody test (anti-HIV), HBsAG and HCV virus.
  • Electrocardiogram (ECG) without clinically significant acute findings.
  • WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination.

Exclusion Criteria:

  • History of nasal or sinus surgery within six months prior to screening or planned nasal or sinus surgery during the trial
  • Active or recent history (within 6 months prior to screening) of chronic sinusitis, nasopharyngeal abnormalities and/or symptoms such as polyps or deviated septum
  • pregnant or breast-feeding women.
  • History or current clinical manifestation of any serious medical condition.
  • History of or active autoimmune disease.
  • Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I.
  • Knowledge/history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • History of anaphylaxis or severe allergic reaction to any vaccine.
  • Chronic systemic administration defined as more than 14 days of > 5 mg prednisone per day

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Group 1

    Group 2

    Group 3

    Group 4

    Group 5

    Arm Description

    ≥55 year old healthy subjects, receiving either 5x10E7 TCID50 MVA-BN-RSV or Placebo intranasal application

    ≥55 year old healthy subjects, receiving either 1x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application

    ≥55 year old healthy subjects, receiving either 5x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application

    ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intranasal and intramuscular application

    ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intramuscular application

    Outcomes

    Primary Outcome Measures

    Occurrence of serious adverse events
    Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).

    Secondary Outcome Measures

    RSV-specific humoral immune response
    To assess the RSV-specific serum antibody responses

    Full Information

    First Posted
    August 9, 2016
    Last Updated
    August 23, 2018
    Sponsor
    Bavarian Nordic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02864628
    Brief Title
    RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
    Official Title
    A Partially Randomized, Partly Placebo Controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA-BN® RSV Vaccine After Intranasal and Intramuscular Administration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Protocol was withdrawn from IND
    Study Start Date
    September 2016 (Anticipated)
    Primary Completion Date
    October 27, 2017 (Actual)
    Study Completion Date
    October 27, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bavarian Nordic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or 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
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    ≥55 year old healthy subjects, receiving either 5x10E7 TCID50 MVA-BN-RSV or Placebo intranasal application
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    ≥55 year old healthy subjects, receiving either 1x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application
    Arm Title
    Group 3
    Arm Type
    Experimental
    Arm Description
    ≥55 year old healthy subjects, receiving either 5x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application
    Arm Title
    Group 4
    Arm Type
    Experimental
    Arm Description
    ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intranasal and intramuscular application
    Arm Title
    Group 5
    Arm Type
    Experimental
    Arm Description
    ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intramuscular application
    Intervention Type
    Biological
    Intervention Name(s)
    MVA-BN-RSV
    Intervention Description
    MVA-mBN294B
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Tris Buffered Saline
    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
    Secondary Outcome Measure Information:
    Title
    RSV-specific humoral immune response
    Description
    To assess the RSV-specific serum antibody responses
    Time Frame
    humoral immune response is measured up to week 34

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: signed and dated an informed consent form and HIPAA. Subjects without symptomatic cardiopulmonary and/or metabolic disease. Body mass index (BMI) ≥ 18.5 and ≤ 34.9. Negative human immunodeficiency virus antibody test (anti-HIV), HBsAG and HCV virus. Electrocardiogram (ECG) without clinically significant acute findings. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination. Exclusion Criteria: History of nasal or sinus surgery within six months prior to screening or planned nasal or sinus surgery during the trial Active or recent history (within 6 months prior to screening) of chronic sinusitis, nasopharyngeal abnormalities and/or symptoms such as polyps or deviated septum pregnant or breast-feeding women. History or current clinical manifestation of any serious medical condition. History of or active autoimmune disease. Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I. Knowledge/history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. History of anaphylaxis or severe allergic reaction to any vaccine. Chronic systemic administration defined as more than 14 days of > 5 mg prednisone per day
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos Fierro, MD
    Organizational Affiliation
    Johnson County Clin-Trials (JCCT)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.

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