Ebola CVD-Mali #2000 (Bivalent) VRC-EBOAdc069-00-vp (cAd3-EBO)

Summary

Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection.

This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate vaccine VRC-EBOADC069-00-VP (cAD3-EBO) when administered to healthy Malian adult volunteers, age 18-65 years (mostly health care workers and other front line workers \[e.g., individuals who incinerate contaminated materials\]), at one of 2 dosage levels, 2.0 x 10(10) vp or 2 x 10(11) vp. It is impossible for someone to get an Ebola infection from this vaccine.

Heterologous booster dose allocation - Each participant will be offered the opportunity to be included in the booster step of this study. After obtaining consent and the additional review of pertinent medical history, participants in each group will be randomized to receive the candidate booster vaccine, MVA-EbolaZ or placebo.

This will be the first clinical trial in Mali with bivalent cAd3-based Ebola vaccine and the first where the dosage level contains \> 10(11) vp. It follows completion of a Phase Ib trial in Malian health care workers that tested three dosage levels of monovalent cAd3-EBO Z vaccine. The data generated in West Africans (Mali) on the tolerability and immunogenicity of the bivalent vaccine will be compared to clinical and immunologic responses documented in in parallel studies in East African subjects (Uganda) and North American subjects (NIH, Bethesda, MD, USA).

Objectives:

* To see if an Ebola vaccine is safe and to study immune responses to it.
* To study the effect of the MVA-EbolaZ booster on the immune response

Eligibility:

\- Healthy adults ages 18-65.

Conditions

• Ebola Virus Disease
• Hemorrhagic Fever

Interventions

BIOLOGICAL

VRC-EBOADC069-00-vp

IM Injection of cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(10) vp)

BIOLOGICAL

VRC-EBOADC069-00-vp

IM Injection of cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(11) vp)

BIOLOGICAL

MVA-EbolaZ

IM injection of MVA-EbolaZ vaccine

OTHER

Placebo

IM injection injection of Phosphate Buffered Saline

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of Maryland, Baltimore

  lead OTHER

Principal Investigators

• Myrons M Levine, MD DTPH · University of Maryland, Baltimore

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2016-09-27

Completion

2016-09-27

Countries

• Mali

Study Locations