Evaluating an Ebola and a Marburg Vaccine in Uganda

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT00997607
• Date of registration: 16/10/2009
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Evaluating an Ebola and a Marburg Vaccine in Uganda
• Scientific title: A Phase IB Study to Evaluate the Safety and Immunogenicity of an Ebola DNA Plasmid Vaccine, VRC-EBODNA023-00-VP, and a Marburg DNA Plasmid Vaccine, VRC-MARDNA025-00-VP, in Healthy Adults in Kampala, Uganda
• Date of first enrolment: February 2010
• Target sample size: 108
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00997607
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Countries of recruitment

Uganda

Contacts

• Name: Hannah Kibuuka, MBChB, MMed, MPH
• Affiliation: Makerere University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 (ß-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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola Virus Disease

Marburg Virus Disease

Intervention(s)

Biological: Ebola vaccine

Biological: Marburg vaccine

Other: Placebo injection

Primary Outcome(s)

Safety of Ebola vaccine, as seen in local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences [Time Frame: Measured at 11 or more visits over 2 years]

Safety of Marburg vaccine, as seen in local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences [Time Frame: Measured at 11 or more visits over 2 years]

Secondary Outcome(s)

Immunogenicity of Ebola vaccine, as seen in ELISA antigen-specific assays for antibodies, intracellular cytokine staining (ICS) assay, and an ELISPOT antigen-specific assay for T cell responses [Time Frame: Measured at baseline and Week 12]

Immunogenicity of Marburg vaccine, as seen in ELISA antigen-specific assays for antibodies, intracellular cytokine staining (ICS) assay, and an ELISPOT antigen-specific assay for T cell responses [Time Frame: Measured at baseline and Week 12]

Secondary ID(s)

RV 247

Source(s) of Monetary Support

Please refer to primary and secondary sponsors