Status:
COMPLETED
Evaluating an Ebola and a Marburg Vaccine in Uganda
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Ebola Virus Disease
Marburg Virus Disease
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if they are safe, if they have side effects, and if they create an immune response in people who receive them.
Detailed Description
The Ebola and Marburg viruses are both filoviruses known to induce hemorrhagic fever-a set of symptoms characterized by sudden onset, aching, fever, and bleeding in the internal organs. Both filovirus...
Eligibility Criteria
Inclusion
- Available for clinical follow-up through Week 104
- Willing to have photo taken for identification purposes
- Willing to be taken home at enrollment visit and allow home visits if appointments are not kept
- Completes an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions at least once in 3 attempts
- In good general health without clinically significant medical history
- Has a physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment
- Female participants of reproductive potential must have a negative result on a human choriogonadotropin (β-HCG) pregnancy test
- Female participants must either be incapable of becoming pregnant or agree to take appropriate precautions that pregnancy will not occur during the first 24 weeks of the study
Exclusion
- Pregnant, breast-feeding, or planning to become pregnant during the first 24 weeks after enrollment
- History of Ebola or Marburg virus exposure
- Occupational health risk of exposure to the Ebola or Marburg virus known to be higher than that of the general population
- Has received any of the following substances:
- Investigational Ebola or Marburg vaccine in a prior clinical trial
- Blood products within 120 days prior to HIV screening
- Immunoglobulin within 60 days of prior to HIV screening
- Live attenuated vaccines within 30 days prior to initial study vaccine administration
- Investigational research agents within 30 days prior to initial study vaccine administration
- Medically indicated subunit or killed vaccines (such as influenza, pneumococcal, or allergy treatment with antigen injections) within 14 days of study vaccine administration
- Current anti-tuberculosis prophylaxis or therapy
- Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within 12 weeks of enrollment, except in the following cases: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroids for a non-chronic condition (based on investigator clinical judgement) at least 2 weeks prior to enrollment in this study
- History of serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain
- Presence of idiopathic urticaria within the past 2 years
- History of autoimmune disease or immunodeficiency
- History of unstable asthma; asthma that required emergent care, urgent care, hospitalization or intubation during the past 2 years; or asthma that requires the use of oral or parenteral corticosteroids
- History of diabetes mellitus (type I or II), with the exception of a history of gestational diabetes
- History of thyroidectomy or thyroid disease that required medication within the past 12 months
- History of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema
- History of hypertension that is not well controlled by medication or blood pressure that is more than 145/95 mm Hg at enrollment
- Presence of a bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bruising or bleeding difficulties with intramuscular injections or blood draws, or routine use of anticoagulant medications
- Presence of active malignancy, 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
- History of a seizure or seizure disorder
- Asplenia, functional asplenia, or any condition resulting in the absence or removal of the spleen
- Allergic reaction to aminoglycoside antibiotics
- Presence of a psychiatric condition that precludes compliance with the protocol
- History of psychoses, bipolar disorder, disorder requiring lithium, or suicide plan or attempt within 5 years prior to enrollment
- Any medical, psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent
- Evidence of syphilis based on history, exam, and rapid plasma reagin (RPR) test results
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00997607
Start Date
February 1 2010
End Date
April 1 2012
Last Update
January 28 2013
Active Locations (1)
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1
Makerere University Walter Reed Project (MUWRP) clinic
Kampala, Uganda