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A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA‐BN‐Filo in Healthy Adult Participants

2015-09-09 01:23:22 | BioPortfolio

Summary

The purpose of this study is to demonstrate the non‐inferiority of a heterologous prime‐boost regimen using Ad26.ZEBOV as prime and MVA‐BN‐Filo as boost administered at different doses at a 56‐day interval versus the same regimen with the recently released batches of Ad26.ZEBOV and MVA‐BN‐Filo in terms of humoral immune response against the Ebola virus (EBOV) GP (Glycoprotein) as measured by Enzyme‐linked Immunosorbent Assay (ELISA).

Description

This is a randomized, double‐blind, placebo‐controlled, parallel‐group, multicenter study to evaluate safety and immunogenicity of Ad26.ZEBOCV and MVA‐BN‐Filo at different dose levels, administered to healthy adults participants. The study consists of a Screening period of up to 6 weeks, a vaccination period in which participants will be vaccinated at baseline (Day 1), followed by a boost vaccination on Day 57, and a post‐vaccination phase until the 42 day post‐boost visit (Day 99). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.

Study Design

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

Conditions

Ebola Vaccine

Intervention

Ad26.ZEBOV 5*10^10 viral particles (vp), Ad26.ZEBOV 2*10^10 (vp), Ad26.ZEBOV 0.8*10^10 (vp), MVA‐BN‐Filo 1*10^8 Infectious Unit [Inf. U.], MVA‐BN‐Filo 5*10^7 Inf. U., Placebo

Location

Huntsville
Alabama
United States

Status

Not yet recruiting

Source

Crucell Holland BV

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-09-09T01:23:22-0400

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Medical and Biotech [MESH] Definitions

Method for measuring viral infectivity and multiplication in CULTURED CELLS. Clear lysed areas or plaques develop as the VIRAL PARTICLES are released from the infected cells during incubation. With some VIRUSES, the cells are killed by a cytopathic effect; with others, the infected cells are not killed but can be detected by their hemadsorptive ability. Sometimes the plaque cells contain VIRAL ANTIGENS which can be measured by IMMUNOFLUORESCENCE.

Method for measuring viral infectivity and multiplication in cultured cells. Clear lysed areas or plaques develop as the viral particles are released from the infected cells during incubation. With some viruses, the cells are killed by a cytopathic effect; with others, the infected cells are not killed but can be detected by their hemadsorptive ability. Sometimes the plaque cells contain viral antigens which can be measured by immunofluorescence.

Viral proteins that are components of the mature assembled VIRUS PARTICLES. They may include nucleocapsid core proteins (gag proteins), enzymes packaged within the virus particle (pol proteins), and membrane components (env proteins). These do not include the proteins encoded in the VIRAL GENOME that are produced in infected cells but which are not packaged in the mature virus particle,i.e. the so called non-structural proteins (VIRAL NONSTRUCTURAL PROTEINS).

Proteins encoded by a VIRAL GENOME that are produced in the organisms they infect, but not packaged into the VIRUS PARTICLES. Some of these proteins may play roles within the infected cell during VIRUS REPLICATION or act in regulation of virus replication or VIRUS ASSEMBLY.

The interactions of particles responsible for their scattering and transformations (decays and reactions). Because of interactions, an isolated particle may decay into other particles. Two particles passing near each other may transform, perhaps into the same particles but with changed momenta (elastic scattering) or into other particles (inelastic scattering). Interactions fall into three groups: strong, electromagnetic, and weak. (From McGraw-Hill Encyclopedia of Science & Technology, 7th ed)

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