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

Completed · Phase 1 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infections

In brief

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.

Key facts

Study ID

NCT02419391

Run by

Bavarian Nordic

People needed

63

Starts

2015-08-01

Expected to finish

2016-05-01

Last updated by the study team

2016-08-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Johnson County Clin-Trials (JCCT) — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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