NCT02370589

Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Vaccine in Healthy Subjects

A Phase 1, Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Nanoparticle Vaccine, With or Without Matrix-M™ Adjuvant, in Healthy Subjects ≥18 to <50 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, observer-blind, placebo-controlled trial in male and female subjects ≥18 to \<50 years of age. Subjects will be healthy adults based on history, physical examination, and baseline clinical laboratory testing. Approximately 230 eligible subjects will be enrolled into 1 of 13 treatment groups. Treatments will comprise two IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids with the test article assigned (i.e., saline placebo, dose of EBOV GP vaccine with or without Matrix-M adjuvant), in a 0.5mL injection volume.

Conditions

• Ebola

Interventions

Type	Name	Description
BIOLOGICAL	Base Dose EBOV GP Vaccine
BIOLOGICAL	2x Base Dose EBOV GP Vaccine
BIOLOGICAL	4x Base Dose EBOV GP Vaccine
BIOLOGICAL	8x Base Dose EBOV GP Vaccine
BIOLOGICAL	Placebo
BIOLOGICAL	Matrix-M Adjuvant

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-02-25
• Last updated: 2021-11-24

Locations

3 sites across 1 country: Australia