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

Bavarian Nordic

Status and phase: Withdrawn; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Other: Placebo; Biological: MVA-BN-RSV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02864628

RSV-MVA-006

Details and patient eligibility

About

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.

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 5 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Other: Placebo

Biological: MVA-BN-RSV

Group 2

Experimental group

Description:

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

Treatment:

Other: Placebo

Biological: MVA-BN-RSV

Group 3

Experimental group

Description:

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

Treatment:

Other: Placebo

Biological: MVA-BN-RSV

Group 4

Experimental group

Description:

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

Treatment:

Biological: MVA-BN-RSV

Group 5

Experimental group

Description:

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

Treatment:

Biological: MVA-BN-RSV