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
VRC 208: Phase 1/1b Open-Label Clinical Trial to Evaluate Dose, Safety and Immunogenicity of Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine,VRC-EBOMVA079-00-VP, Administered Alone or as Boost to cAd3-Ebola Vaccines in Healthy Adults
Other study identifiers
Sponsor study identifier
Secondary identifiers
interventional
140
1 country
3
Study Start
March 26, 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 6, 2017
Actual (reported)Study Completion
April 6, 2017
Actual (reported)Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 140 participants
- Study completion date
April 6, 2017
Actual (reported)- Listed locations
- 1 countries · 3 sites
Trial Relationships
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
March 26, 2015
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
April 3, 2015
Actual (reported)First Posted
April 6, 2015
Actual (reported)Primary Completion
April 6, 2017
Actual (reported)Study Completion
April 6, 2017
Actual (reported)
- Last Updated
- April 11, 2019
- Status Verified
- April 6, 2017
- Last Update Submitted
- April 10, 2019