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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Biological: MVA-BN-RSV
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RSV Vaccines, Respiratory Syncytial Virus Vaccines