RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
Respiratory Syncytial Virus Infections
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
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
Experimental
Experimental
Experimental
Experimental
Experimental
Group 1
Group 2
Group 3
Group 4
Group 5
≥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