Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine

Study Overview
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Brief Summary
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A total of 63 subjects will be recruited into three groups (18 subjects per group will receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen suspension of MVA BN RSV. Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per 0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.

Official Title
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A Randomized, Single-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine in Healthy Adult Subjects

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 Body mass index ≥ 18.5 and < 35. Women of childbearing potential (WOCBP) must have used an acceptable method of contraception Exclusion Criteria: Pregnant or breast-feeding women. Uncontrolled serious infection, i.e. not responding to antimicrobial therapy. History of any serious medical condition. History of or active autoimmune disease. Known or suspected impairment of immunologic functions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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>18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo | Biological: MVA BN RSV<br>* Liquid frozen suspension of MVA-mBN294B<br>* Other names: MVA-mBN294B;Other: Placebo<br>* Tris Buffered Saline, sterile<br>* Other names: TBS;|
| Experimental: Group 2<br>18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo | Biological: MVA BN RSV<br>* Liquid frozen suspension of MVA-mBN294B<br>* Other names: MVA-mBN294B;Other: Placebo<br>* Tris Buffered Saline, sterile<br>* Other names: TBS;|
| Experimental: Group 3<br>50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo | Biological: MVA BN RSV<br>* Liquid frozen suspension of MVA-mBN294B<br>* Other names: MVA-mBN294B;Other: Placebo<br>* Tris Buffered Saline, sterile<br>* Other names: TBS;|

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 | 
| Occurrence of grade 3 adverse events | Occurrence of any grade 3 or higher adverse events possibly, probably or definitely related to the trial vaccine within four weeks after each vaccination. | Screening up to week 8 after first vaccination | 
| Solicited local adverse events | Occurrence, intensity and duration of solicited local adverse events after each vaccination Occurrence, intensity and duration of solicited local adverse events after each vaccination Occurrence, intensity and duration of solicited local adverse events after each vaccination | day of vaccination and the following seven days | 
| Unsolicited non-serious adverse events | Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events | within four weeks after each vaccination | 
| Solicited general adverse events | Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events | day of vaccination and the following seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccinia-specific cellular immune responses. | To assess the RSV-specific and vaccinia-specific cellular immune responses against the MVA-BN RSV vaccine in healthy adult subjects. Spot forming units will be determined by using an IFN-γ ELISPOT assay. | cellular immune response measured up to week 4 after 2nd vaccination | 
| RSV-specific humoral immune response | To assess the RSV-specific serum antibody responses by ELISA | humoral immune response is measured up to week 34 | 
| RSV-specific humoral immune response | To assess the RSV-specific serum antibody responses by PRNT | humoral immune response is measured up to week 34 | 
| RSV-specific humoral immune response | To assess the RSV-specific mucosal antibody responses by ELISA | humoral immune response is measured up to week 34 | 
| Vaccinica-specific humoral immune response | To assess the Vaccinica-specific serum antibody responses by ELISA | 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