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

Phase 1CompletedNCT02419391

Bavarian Nordic63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Respiratory Syncytial Virus Infections

Interventions

MVA BN RSVBIOLOGICAL

Liquid frozen suspension of MVA-mBN294B

PlaceboOTHER

Tris Buffered Saline, sterile

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Johnson County Clin-Trials (JCCT)

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

Occurrence of serious adverse events

Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).

Time frame: Screening up to week 34 after first vaccination

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.

Time frame: Screening up to week 8 after first vaccination

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

Time frame: day of vaccination and the following seven days

Unsolicited non-serious adverse events

Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events

Time frame: within four weeks after each vaccination

Solicited general adverse events

Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events

Time frame: day of vaccination and the following seven days

Secondary Outcomes

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-γ ELISPOT assay.

Time frame: cellular immune response measured up to week 4 after 2nd vaccination

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.