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Completed

NCT Number: NCT02419391

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

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.

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johnson County Clin-Trials (JCCT)

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MVA BN RSV

Biological

Liquid frozen suspension of MVA-mBN294B

Other names: MVA-mBN294B

Placebo

Other

Tris Buffered Saline, sterile

Other names: TBS

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bavarian Nordic

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 17, 2015
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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