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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419391
• Other study ID #: RSV-MVA-001
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2015
• Last updated: August 9, 2016
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Biological:
• MVA BN RSV
Liquid frozen suspension of MVA-mBN294B

Other:
• Placebo
Tris Buffered Saline, sterile

Locations

Country	Name	City	State
United States	Johnson County Clin-Trials (JCCT)	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bavarian Nordic

Country where clinical trial is conducted

United States, 

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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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-? ELISPOT assay.	cellular immune response measured up to week 4 after 2nd vaccination	No
Secondary	RSV-specific humoral immune response	To assess the RSV-specific serum antibody responses by ELISA	humoral immune response is measured up to week 34	No
Secondary	RSV-specific humoral immune response	To assess the RSV-specific serum antibody responses by PRNT	humoral immune response is measured up to week 34	No
Secondary	RSV-specific humoral immune response	To assess the RSV-specific mucosal antibody responses by ELISA	humoral immune response is measured up to week 34	No
Secondary	Vaccinica-specific humoral immune response	To assess the Vaccinica-specific serum antibody responses by ELISA	humoral immune response is measured up to week 34	No