MedTrace Logo

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

NCT02370589 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2021-11-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Novavax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02370589 on ClinicalTrials.gov