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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Withdrawn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

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

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

NCT ID

NCT02864628

First Posted

August 9, 2016

Last Updated

August 23, 2018

Sponsor

Bavarian Nordic

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

Data Monitoring Committee

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

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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