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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: MVA BN RSV; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials (JCCT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: MVA-mBN294B; Other: Placebo; Tris Buffered Saline, sterile; Other Names: 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 Names: MVA-mBN294B; Other: Placebo; Tris Buffered Saline, sterile; Other Names: 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 Names: MVA-mBN294B; Other: Placebo; Tris Buffered Saline, sterile; Other Names: TBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of serious adverse events	Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).	Screening up to week 34 after first vaccination
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.	Screening up to week 8 after first 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	day of vaccination and the following seven days
Unsolicited non-serious adverse events	Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events	within four weeks after each vaccination
Solicited general adverse events	Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events	day of vaccination and the following seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	cellular immune response measured up to week 4 after 2nd vaccination
RSV-specific humoral immune response	To assess the RSV-specific serum antibody responses by ELISA	humoral immune response is measured up to week 34
RSV-specific humoral immune response	To assess the RSV-specific serum antibody responses by PRNT	humoral immune response is measured up to week 34
RSV-specific humoral immune response	To assess the RSV-specific mucosal antibody responses by ELISA	humoral immune response is measured up to week 34
Vaccinica-specific humoral immune response	To assess the Vaccinica-specific serum antibody responses by ELISA	humoral immune response is measured up to week 34

Collaborators and Investigators

• Sponsor: Bavarian Nordic
• Investigators: Principal Investigator: Casey Johnson, DO, Johnson County Clin-Trials (JCCT)

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: RSV Vaccines; Respiratory Syncytial Virus Vaccines
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: RSV-MVA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No