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VRC 208: Dose, Safety and Immunogenicity of a Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine, VRC-EBOMVA079-00-VP (MVA-EbolaZ), Administered Alone or as a Boost to cAd3-Ebola Vaccines in Healthy Adults

NCT02408913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2019-04-11

No results posted yet for this study

Summary

Background:

\- Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved treatments for Ebola. Researchers want to see if two new vaccines VRC-EBOMVA079-00-VP (MVA-EbolaZ) and VRC-EBOADC069-00VP ( cAd3-EBO ) are safe and able to induce an immune response against Ebola.

Objectives:

\- To see if the two new vaccines are safe and if they cause any side effects. Also, to study immune responses to the vaccines.

Eligibility:

\- Healthy adults ages 18-66

Design:

* Participants will get one or two study vaccine injections depending on the study group they are assigned to. Each injection will repeat the same schedule:
* A needle and syringe will inject the vaccine into an upper arm muscle.
* 1-2 days later, participants must call the clinic to report how they feel.
* For 7 days they will check their temperature with a thermometer given to them. They will look at the injection site, and measure any redness or swelling with a ruler. They will write down any symptoms they have.
* In the first 2 months, participants will have at least 6 clinic visits and 1 phone contact. At each visit, participants will be checked for health changes or problems. They will tell how they feel and if they have taken any medications. Blood and urine samples may be collected.
* Participants might need to have extra clinic visits and laboratory tests if they have health changes that need to be checked.

Conditions

  • Healthy Adult Immune Responses to Vaccine

Interventions

BIOLOGICAL

VRC-EBOMVA079-00-VP (MVA-EbolaZ)

Ebola Modified Vaccinia Virus Ankara Vaccine

BIOLOGICAL

VRC-EBOADC069-00-VP (cAd3-EBO)

Ebola Chimpanzee Adenovirus Vector Vaccine

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Julie E Ledgerwood, D.O. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-03-26
Primary Completion
2017-04-06
Completion
2017-04-06

Countries

  • United States

Study Locations

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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 NCT02408913 on ClinicalTrials.gov