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.

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