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NCT02408913 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
NCT02408913 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 140 participants.
The verdict
NCT02408913, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
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.
Interventions
- BIOLOGICAL VRC-EBOMVA079-00-VP (MVA-EbolaZ)
- BIOLOGICAL VRC-EBOADC069-00-VP (cAd3-EBO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2015-03-26 |
| Est. Completion | 2017-04-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02408913
The ClinicalTrials.gov registry entry for NCT02408913 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which VRC-EBOMVA079-00-VP (MVA-EbolaZ) is the first listed.
NCT02408913 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02408913 about?
NCT02408913 is a clinical study titled "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". 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 VR...
What is the current status of trial NCT02408913?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2015-03-26. Estimated completion is 2017-04-06.
What interventions are being tested in trial NCT02408913?
The interventions under investigation include: VRC-EBOMVA079-00-VP (MVA-EbolaZ) (BIOLOGICAL), VRC-EBOADC069-00-VP (cAd3-EBO) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02408913?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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