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

Completed · Phase 1

Conditions studied: Healthy Adult Immune Responses to Vaccine

In brief

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.

Key facts

Study ID

NCT02408913

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

140

Starts

2015-03-26

Expected to finish

2017-04-06

Last updated by the study team

2019-04-11

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Exclusion Criteria for Groups 1, 2, and 3
• A volunteer will be excluded if one or more of the following conditions apply:
• Volunteer has received any of the following substances:
• Investigational Marburg vaccine in a prior clinical trial.
• Investigational Ebola vaccine in a prior clinical trial.
• Investigational cAd3 or MVA vaccines in a prior clinical trial.
• Evidence of increased cardiovascular disease risk defined as >10% five year risk by the non-laboratory method.
• Electrocardiogram (ECG) with clinically significant abnormalities (examples may include: pathologic Q waves, significant ST-T wave changes, left ventricular hypertrophy, any non-sinus rhythm excluding isolated premature atrial contractions, right or left bundle branch block, advanced A-V heart block). ECG abnormalities determined by a cardiologist to be clinically insignificant as related to study participation do not preclude study enrollment.
• Type 1 hypersensitivity reaction to aminoglycoside antibiotics.
• More than 10 days of systemic immunosuppressive medications except for short-term treatments of minor ailments in otherwise healthy volunteers, or cytotoxic medications within the 4 weeks prior to enrollment, or any within the 14 days prior to enrollment.
• Blood products within 112 days (16 weeks) prior to enrollment.
• Investigational research agents within 28 days (4 weeks) prior to enrollment.
• Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal within 2 weeks of initial study vaccine administration unless approved by the study Principal Investigator (PI) or designee
• Current anti-tuberculosis prophylaxis or therapy.
• Female-specific criteria:
• Woman who is breast-feeding or planning to become pregnant during the 24 weeks of study participation.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
• Clinically significant autoimmune disease or immunodeficiency.
• Asthma that is not well controlled.
• Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• Thyroid disease that is not well controlled.
• A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
• Idiopathic urticaria within the last 1 year.

Where it is running

• Hope Clinic - Emory Vaccine Ctr — Decatur, Georgia, United States
• University of Maryland, Baltimore — Baltimore, Maryland, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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