Clinical Trial of Ebola Vaccines cAd3-EBO, cAd3-EBOZ and MVA-EbolaZ in Healthy Adults in Uganda

This is an interventional prevention trial for Hemorrhagic Fever, Ebola focused on measuring Ebola virus, Filoviridae Infections, Hemorrhagic Fever, Ebola, Viral Diseases, Hemorrhagic Fevers, Viral Read More

Part 1 Inclusion Criteria:

A volunteer subject must meet all of the following criteria:

• 18 to 65 years old.
• Available for clinical follow-up through Week 48.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Must be willing to be taken home at enrollment visit and allow home visits if participant does not keep appointments
• Must complete an Assessment of Understanding successfully.
• Able to read (English or Luganda) and willing to complete the informed consent process.
• Willing to donate blood for sample storage to be used for future research.
• In good general health without clinically significant medical history.
• Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) ≤ 40 within the 56 days prior to enrollment.

Laboratory Inclusion Criteria within 56 days prior to enrollment:

• Hemoglobin ≥ 11.0 g/dL for women; ≥12.5 g/dL for men.
• White blood cells (WBC) = 2,500-12,000 cells/mm3.
• WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
• Total lymphocyte count ≥ 800 cells/mm3.
• Platelets = 125,000 - 400,000/mm3.
• Alanine aminotransferase (ALT) ≤ 1.25 x upper limit of normal (ULN).
• Serum creatinine ≤ 1 x ULN.
• Partial thromboplastin time (PTT) within institutional normal range.
• Prothrombin time (PT) within institutional normal range.
• HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic test.

Female-Specific Inclusion Criteria:

• Negative β-HCG (human chorionic gonadotropin) pregnancy test on day of enrollment.
• Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 24 weeks after study vaccination if presumed to be of reproductive potential.

Part 1 Exclusion Criteria:

Volunteer has received any of the following substances:

• Investigational Ebola or Marburg vaccine (other than the Ebola DNA vaccine delivered in RV 247) in a prior clinical trial or prior receipt of a cAd3 adenoviral vectored investigational vaccine.
• Chronic use of immunomodulators and systemic glucocorticoids in daily doses of glucocorticoid equivalence > 20 mg of prednisolone, for periods exceeding 10 days. Non-steroidal anti-inflammatory drugs [NSAIDS] are permitted.
• Participants that have used less than the stated glucocorticoid dose may still be excluded at the Investigator's discretion.
• Blood products within 112 days prior to enrollment.
• Investigational research agents within 28 days prior to enrollment.
• Live attenuated vaccines within 28 days prior to enrollment.
• Subunit or killed vaccines within 14 days prior to enrollment.
• Current anti-tuberculosis prophylaxis or therapy.

Female-Specific Exclusion 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.
• 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 volunteer's ability to give informed consent.

Part 2 Inclusion Criteria:

• Received the Part 1 study injection and is willing to participate in Part 2.
• Satisfactory completion of the Assessment of Understanding
• Subject is assessed by the Site Principal Investigator or designee as in good general health without clinically significant medical history that precludes participation.

Female-Specific Inclusion Criteria:

• Negative β-HCG pregnancy test on day of enrollment if presumed to be of reproductive potential.
• Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 24 weeks after study vaccination if presumed to be of reproductive potential.

Part 2 Exclusion Criteria:

• Type 1 hypersensitivity to aminoglycosides antibiotics.