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

NCT ID: NCT02864628

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-10-27

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.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 1

≥55 year old healthy subjects, receiving either 5x10E7 TCID50 MVA-BN-RSV or Placebo intranasal application

Group Type: EXPERIMENTAL

MVA-BN-RSV

Intervention Type: BIOLOGICAL

MVA-mBN294B

Placebo

Intervention Type: OTHER

Tris Buffered Saline

Group 2

≥55 year old healthy subjects, receiving either 1x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application

Group Type: EXPERIMENTAL

MVA-BN-RSV

Intervention Type: BIOLOGICAL

MVA-mBN294B

Placebo

Intervention Type: OTHER

Tris Buffered Saline

Group 3

≥55 year old healthy subjects, receiving either 5x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application

Group Type: EXPERIMENTAL

MVA-BN-RSV

Intervention Type: BIOLOGICAL

MVA-mBN294B

Placebo

Intervention Type: OTHER

Tris Buffered Saline

Group 4

≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intranasal and intramuscular application

Group Type: EXPERIMENTAL

MVA-BN-RSV

Intervention Type: BIOLOGICAL

MVA-mBN294B

Group 5

≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intramuscular application

Group Type: EXPERIMENTAL

MVA-BN-RSV

Intervention Type: BIOLOGICAL

MVA-mBN294B

Interventions

MVA-BN-RSV

MVA-mBN294B

Intervention Type: BIOLOGICAL

Placebo

Tris Buffered Saline

Intervention Type: OTHER

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bavarian Nordic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Fierro, MD

Role: PRINCIPAL_INVESTIGATOR

Johnson County Clin-Trials (JCCT)

Other Identifiers

RSV-MVA-006

Identifier Type: -

Identifier Source: org_study_id