Safety, Tolerability, and Immunogenicity of the Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO), VRC-EBOADC069-00-VP, in Healthy Adults

Completed · Phase 1

Conditions studied: Healthy Adult Immune Responses to Vaccine

In brief

Background: \- 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. It is impossible for someone to get an Ebola infection from this vaccine. Objectives: \- To see if an Ebola vaccine is safe and to study immune responses to it. Eligibility: \- Healthy adults ages 18-65. Design: * Participants will be screened through a separate protocol. * Participants will receive the vaccine injection by needle and syringe into an upper arm muscle. - Participants will stay at the clinic for 3 hours after the injection. * About 2 days later, participants must speak with clinic staff about how they are doing. * Every day for 7 days after the injection, participants will record their temperature and symptoms and look at the injection site. They will get a thermometer and a ruler to measure any redness or swelling. They will report any side effects. * In the first 2 months in the study, participants will have at least 6 clinic visits and 1 phone call. They will have at least 3 other visits over the next 9 months. * At each visit, participants will be checked for health changes or problems since their last visit. They will be asked how they feel and if they have taken any medicine. Blood will be drawn at most visits. Urine samples may be collected.

Key facts

Study ID

NCT02231866

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

143

Starts

2014-08-27

Expected to finish

2017-04-05

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A volunteer will be excluded if one or more of the following conditions apply:
• Volunteer has received any of the following substances:
• Investigational Ebola or Marburg vaccine in a prior clinical trial (except for Group 3 volunteers) or prior receipt of a cAd3 adenoviral vectored investigational vaccine.
• Immunosuppressive medications within 2 weeks 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.
• Subunit or killed vaccines within 14 days (2 weeks) prior to enrollment.
• Current anti-tuberculosis prophylaxis or therapy.
• Female-specific criteria:
• Woman who is breast-feeding or planning to become pregnant during the first 24 weeks after study vaccine administration.
• 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.
• Hypertension that is not well controlled.
• Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
• Malignancy that is active or history of a malignancy that is likely to recur during the period of the study.
• Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.
• Asplenia or functional asplenia.
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within five years prior to enrollment, history of a suicide plan or attempt.

Where it is running

• Hope Clinic - Emory Vaccine Ctr — Decatur, Georgia, United States
• University of Maryland Center for Vaccine Development — 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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