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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-05-31

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.

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Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

MVA BN RSV

Intervention Type BIOLOGICAL

Liquid frozen suspension of MVA-mBN294B

Placebo

Intervention Type OTHER

Tris Buffered Saline, sterile

Group 2

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

Group Type EXPERIMENTAL

MVA BN RSV

Intervention Type BIOLOGICAL

Liquid frozen suspension of MVA-mBN294B

Placebo

Intervention Type OTHER

Tris Buffered Saline, sterile

Group 3

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

Group Type EXPERIMENTAL

MVA BN RSV

Intervention Type BIOLOGICAL

Liquid frozen suspension of MVA-mBN294B

Placebo

Intervention Type OTHER

Tris Buffered Saline, sterile

Interventions

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MVA BN RSV

Liquid frozen suspension of MVA-mBN294B

Intervention Type BIOLOGICAL

Placebo

Tris Buffered Saline, sterile

Intervention Type OTHER

Other Intervention Names

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MVA-mBN294B TBS

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes