drugset / Trial / NCT02370589

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

NCT02370589 ↗

Phase 1 Completed 230 enrolled Novavax
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2015-02
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject EBOV GP Vaccine Vaccine — Intramuscular
Subject Matrix-M Adjuvant Unknown — Intramuscular