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Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine

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ClinicalTrials.gov Identifier: NCT02419391
Recruitment Status : Completed
First Posted : April 17, 2015
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: MVA BN RSV Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : August 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo
Biological: MVA BN RSV
Liquid frozen suspension of MVA-mBN294B
Other Name: MVA-mBN294B

Other: Placebo
Tris Buffered Saline, sterile
Other Name: TBS

Experimental: Group 2
18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo
Biological: MVA BN RSV
Liquid frozen suspension of MVA-mBN294B
Other Name: MVA-mBN294B

Other: Placebo
Tris Buffered Saline, sterile
Other Name: TBS

Experimental: Group 3
50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo
Biological: MVA BN RSV
Liquid frozen suspension of MVA-mBN294B
Other Name: MVA-mBN294B

Other: Placebo
Tris Buffered Saline, sterile
Other Name: TBS




Primary Outcome Measures :
  1. Occurrence of serious adverse events [ Time Frame: Screening up to week 34 after first vaccination ]
    Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).

  2. Occurrence of grade 3 adverse events [ Time Frame: 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.

  3. Solicited local adverse events [ Time Frame: 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

  4. Unsolicited non-serious adverse events [ Time Frame: within four weeks after each vaccination ]
    Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events

  5. Solicited general adverse events [ Time Frame: day of vaccination and the following seven days ]
    Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events


Secondary Outcome Measures :
  1. Vaccinia-specific cellular immune responses. [ Time Frame: 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.

  2. RSV-specific humoral immune response [ Time Frame: humoral immune response is measured up to week 34 ]
    To assess the RSV-specific serum antibody responses by ELISA

  3. RSV-specific humoral immune response [ Time Frame: humoral immune response is measured up to week 34 ]
    To assess the RSV-specific serum antibody responses by PRNT

  4. RSV-specific humoral immune response [ Time Frame: humoral immune response is measured up to week 34 ]
    To assess the RSV-specific mucosal antibody responses by ELISA

  5. Vaccinica-specific humoral immune response [ Time Frame: humoral immune response is measured up to week 34 ]
    To assess the Vaccinica-specific serum antibody responses by ELISA



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419391


Locations
United States, Kansas
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Bavarian Nordic
Investigators
Principal Investigator: Casey Johnson, DO Johnson County Clin-Trials (JCCT)

Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT02419391     History of Changes
Other Study ID Numbers: RSV-MVA-001
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Bavarian Nordic:
RSV Vaccines
Respiratory Syncytial Virus Vaccines

Additional relevant MeSH terms:
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs