Experimental Ebola Vaccine Trial

Completed · Phase 1

Conditions studied: Hemorrhagic Fever, Ebola, Healthy

In brief

This study will test the safety of an experimental vaccine developed to protect against Ebola virus infection and to determine if the vaccine induces an immune response to the virus. The Ebola virus causes a disease called Ebola hemorrhagic fever. Symptoms begin with fever and muscle aches and progress to breathing problems, severe bleeding, kidney problems, and shock. The infection may be mild, but it can also lead to death. The vaccine used in this study is made from small parts of Ebola genetic material. It cannot cause Ebola hemorrhagic fever to develop in those who receive it. Healthy volunteers 18 to 44 years of age may be eligible for this study. Candidates will be screened with a medical history, physical examination, and laboratory tests, and complete an "assessment of understanding" questionnaire to show that they understand the study. Depending on their order of entry into the study, participants are assigned to receive one of three vaccine doses or placebo. The first group receives the lowest dose (2 milligram) of vaccine or placebo. If this dose is safe, then the second group receives 4 mg, and if this dose is safe, the third group receives 8 mg. Injections are given in a muscle in the upper arm. Participants receive three injections, each 4 weeks apart (on study days 0, 28, and 56). Participants record their temperature and symptoms in a diary card for 7 days following each injection. They return to the clinic 2 to 3 days after each injection and then 2 weeks after each injection until study week 10. Additional follow-up visits are then scheduled at weeks 12, 24, 38, and 52. At each visit, participants provide a blood and urine sample for testing and have their vital signs, and lymph nodes checked, their weight measured, and their symptoms reviewed. Additional laboratory tests may be requested between visits.

Key facts

Study ID

NCT00072605

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

27

Starts

2003-10-30

Expected to finish

2007-08-22

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 44. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A volunteer will be excluded if one or more of the following conditions apply.
• Women:
• Breast-feeding.
• Volunteer has received any of the following substances:
• Immunosuppressive or cytotoxic medications within the past six months with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis
• Blood products within 120 days prior to HIV screening.
• Immunoglobulin within 60 days prior to HIV screening.
• Live attenuated vaccines within 30 days prior to initial study injection.
• Investigational research agents within 30 days prior to initial study injection.
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days prior to initial study injection.
• Current anti-TB prophylaxis or therapy.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
• Autoimmune disease or immunodeficiency.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
• Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• Thyroid disease including history of thyroidectomy and diagnoses that required medication within the past 12 months.
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.
• Hypertension that is not well controlled by medication or is more than 145/95 at enrollment.
• 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 treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.
• Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.
• Asplenia or any condition resulting in the absence or removal of the spleen.
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled by medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
• Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence or a volunteer's ability to give informed consent.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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