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

Bavarian Nordic

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Biological: MVA BN RSV; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02419391

RSV-MVA-001

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 3 patient groups

Group 1

Experimental group

Description:

18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo

Treatment:

Other: Placebo

Biological: MVA BN RSV

Group 2

Experimental group

Description:

18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo

Treatment:

Other: Placebo

Biological: MVA BN RSV

Group 3

Experimental group

Description:

50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo

Treatment:

Other: Placebo

Biological: MVA BN RSV