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

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

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.

Study Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; ≥55 year old healthy subjects, receiving either 5x10E7 TCID50 MVA-BN-RSV or Placebo intranasal application	Biological: MVA-BN-RSV; MVA-mBN294B; Other: Placebo; Tris Buffered Saline
Experimental: Group 2; ≥55 year old healthy subjects, receiving either 1x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application	Biological: MVA-BN-RSV; MVA-mBN294B; Other: Placebo; Tris Buffered Saline
Experimental: Group 3; ≥55 year old healthy subjects, receiving either 5x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application	Biological: MVA-BN-RSV; MVA-mBN294B; Other: Placebo; Tris Buffered Saline
Experimental: Group 4; ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intranasal and intramuscular application	Biological: MVA-BN-RSV; MVA-mBN294B
Experimental: Group 5; ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intramuscular application	Biological: MVA-BN-RSV; MVA-mBN294B

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSV-specific humoral immune response	To assess the RSV-specific serum antibody responses	humoral immune response is measured up to week 34

Collaborators and Investigators

• Sponsor: Bavarian Nordic
• Investigators: Principal Investigator: Carlos Fierro, MD, Johnson County Clin-Trials (JCCT)

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2016
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

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-006

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: Yes
• Studies a U.S. FDA-regulated device product: No