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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02864628
• Other study ID #: RSV-MVA-006
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 2016
• Est. completion date: October 27, 2017

Study information

• Verified date: August 2018
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Biological:
• MVA-BN-RSV
MVA-mBN294B

Other:
• Placebo
Tris Buffered Saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bavarian Nordic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	RSV-specific humoral immune response	To assess the RSV-specific serum antibody responses	humoral immune response is measured up to week 34