MedTrace Logo

A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults

NCT02860650 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-02-05

No results posted yet for this study

Summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Ad26.Filo

Ad26.Filo intramuscular (IM) injection at a dose of 9\*10\^10 viral particles (vp).

BIOLOGICAL

MVA-BN-Filo

MVA-BN-Filo intramuscular (IM) injection at a dose of 5\*10\^8 infectious units (Inf U).

BIOLOGICAL

Ad26.ZEBOV

Ad26.ZEBOV intramuscular (IM) injection at a dose of 5\*10\^10 vp.

BIOLOGICAL

Placebo

IM injection of 0.9 percent saline.

BIOLOGICAL

MVA-BN-Filo

MVA-BN-Filo intramuscular (IM) injection at a dose of 1\*10\^8 Inf U.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-05-31
Completion
2018-01-31
FDA Drug
Yes

Countries

  • United States

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 NCT02860650 on ClinicalTrials.gov