A Trial to Evaluate the Safety and Systems Biology Response of Ebolavirus Zaire Vaccine (ChAd3-EBO-Z)
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ClinicalTrials.gov Identifier: NCT03583606 |
Recruitment Status :
Completed
First Posted : July 11, 2018
Last Update Posted : July 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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Ebola Disease Immunisation | Biological: ChAd3-EBO-Z Biological: MVA Multi-Filo Ebola Vaccine Other: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 61 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Systems Biology Phase 1 Evaluation of the Safety, Reactogenicity, and Immunogenicity of Chimpanzee Adenovirus Type 3- Vectored Zaire Ebolavirus (ChAd3-EBO-Z) and Modified Vaccinia Ankara- Vectored Multivalent Filovirus (MVA-BN(R)-Filo) Vaccine Candidates |
Actual Study Start Date : | October 23, 2018 |
Actual Primary Completion Date : | January 14, 2020 |
Actual Study Completion Date : | January 14, 2020 |
Arm | Intervention/treatment |
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Experimental: ChAd3-EBO-Z + ChAd3-EBO-Z
ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10^11 vp) intramuscularly into the opposite arm on Day 8, n = 20
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Biological: ChAd3-EBO-Z
Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp)). |
Experimental: ChAd3-EBO-Z + Placebo
ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8, n = 20
|
Biological: ChAd3-EBO-Z
Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp)). Other: Placebo 0.5 mL normal saline administered via IM injection into the deltoid. |
Experimental: ChAd3-EBO-Z + MVA- BN-Filo
ChAd3-EBO-Z (2 x 10^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8, n = 20
|
Biological: ChAd3-EBO-Z
Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp)). Biological: MVA Multi-Filo Ebola Vaccine A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10^8 Infectious Units (IU). |
- Frequency of clinical safety laboratory adverse events (AEs) [ Time Frame: Day 1 to Day 36 ]
- Frequency of serious adverse events (SAEs) [ Time Frame: Day 1 to Day 182 ]
- Frequency of solicited local reactogenicity [ Time Frame: Day 1 to Day 15 ]
- Frequency of systemic reactogenicity [ Time Frame: Day 1 to Day 15 ]
- Frequency of vaccine-related Medically Attended Adverse Events (MAAEs) [ Time Frame: Day 1 to Day 182 ]
- Frequency of vaccine-related unsolicited adverse events (AEs) [ Time Frame: Day 1 to Day 36 ]
- Severity of clinical safety laboratory adverse events (AEs) [ Time Frame: Day 1 to Day 36 ]
- Severity of solicited local reactogenicity [ Time Frame: Day 1 to Day 15 ]
- Severity of systemic reactogenicity [ Time Frame: Day 1 to Day 15 ]
- Severity of vaccine-related unsolicited adverse events (AEs) [ Time Frame: Day 1 to Day 36 ]
- Geometric mean fold rise (GMFR) in titer compared to baseline [ Time Frame: Day 1 to 36 ]Titer measured by Anti- Zaire ebolavirus glycoprotein (anti-EBOV GP) enzyme-linked immunosorbent assay (ELISA)
- Geometric Mean Titer (GMT) [ Time Frame: Day 1 to 36 ]Titer measured by Anti- Zaire ebolavirus glycoprotein (anti-EBOV GP) enzyme-linked immunosorbent assay (ELISA)
- Occurrence of seroconversion [ Time Frame: Day 8 to 36 ]Seroconversion is defined as Anti- Zaire ebolavirus glycoprotein (Anti-EBOV GP) enzyme-linked immunosorbent assay (ELISA) titer > 50 or = / > 4 fold rise of baseline if baseline titer > 50

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Provide written informed consent before initiation of any study procedures.
- Are able to understand and comply with planned study procedures and be available for all study visits/phone calls.
- Males or non-pregnant females ages 18-45, inclusive.
- Subject must have a body mass index (BMI) > / = 18.5 and < 35 kg/m^2.
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Are in good health.
- As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, ER or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (apart from steroids as outlined in the Subject Exclusion Criteria), herbals, vitamins, and supplements are permitted.
- Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
- Pulse is 47 to 105 beats per minute (bpm), inclusive.
- Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
- Diastolic blood pressure (BP) is 55 to 95 mm Hg, inclusive.
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Have acceptable screening laboratories within 28 days prior to enrollment
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Screening labs include white blood cell (WBC), Hgb, platelet count, ANC, sodium, potassium, creatinine, albumin, total protein, PT, PTT, alanine aminotransferase (ALT). Blood Urea Nitrogen (BUN) will be obtained only if creatinine is above normal range.
- Screening laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or due to laboratory error may be repeated once.
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- Have normal screening laboratories for urine protein. Trace protein is acceptable.
- Drug screen for opiates is negative.
- Hemoglobin A1C (HgbA1C) < 6.3% at screening.
- HIV 1/2 antibody negative.
- HCV antibody negative.
- HBsAg negative.
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Women of childbearing potential, must be using an effective method of contraception from 30 days prior to the first study vaccination until 90 days after the second study vaccination.
- Women of childbearing potential are not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with history of documented radiological confirmation test at least 90 days after the procedure (or with use of another birth control method if history of confirmation test not confirmed), still menstruating, or < 1 year of the last menses if menopausal.
-- Effective methods of contraception includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination.
- Women agree to not donate eggs (ova, oocytes) from the start of screening onwards until at least 90 days after the second vaccination.
- Agrees not to participate in another clinical trial during the study period.
- Agrees not to donate blood to a blood bank for 3 months after receiving the second study vaccine.
Exclusion Criteria:
- Women who are pregnant, planning to become pregnant or lactating. - Includes breastfeeding or planning to breastfeed at any given time from the receipt of study vaccination through the 6-month trial period.
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Known allergy or history of anaphylaxis, severe local or other serious adverse reactions to vaccines or vaccine products, or history of severe allergic reactions.
- Includes a known allergy to egg, egg products and aminoglycosides or any of the constituents of the study vaccines [e.g., polysorbate 80, ethylenediaminetetraacetic acid (EDTA), L-histidine, tris (hydroxymethyl)-amino methane (THAM)).
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Received an experimental agent within 3 months prior to Day 1, or expects to receive an experimental agent (other than from participation in this study) during the 6-month trial-reporting period.
- Including vaccine, drug, biologic, device, blood product, or medication.
- Received immunoglobulin or other blood product within 3 months before enrollment in this study.
- Received any licensed live vaccine within 30 days prior to the first study vaccination through 30 days after the second study vaccination.
- Received a licensed inactivated vaccine within 14 days prior to the first study vaccination through 14 days after the second study vaccination.
- Has been vaccinated with an Ebola vaccine.
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Has been diagnosed with Ebola disease, or exposed to Ebola virus including travel to West Africa in 2014-2016.
- West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, Nigeria, and Sierra Leone.
- Known or suspected receipt of ChAd3-EBO-Z or other ChAd3-vectored vaccine.
- Known or suspected receipt of an adenovirus serotype 5 (Ad5)-based vaccine.
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Known or suspected receipt of any licensed or investigational small pox (vaccinia)-based vaccine.
- Includes any MVA-based candidate vaccine (Imvamune or Imvanex), Dryvax, or Acam2000.
- Has a typical vaccinia scar.
- Confirmed Asplenia/Functional Asplenia.
- A history of bleeding or clotting disorders.
- Thyroidectomy or thyroid disease requiring medication during the last 12 months.
- History of chronic urticaria (recurrent hives).
- Individuals in whom the ability to observe possible local reactions at the eligible injection sites (left and right deltoid region) is, unacceptably obscured due to a physical condition or permanent body art.
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Have an acute illness, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
- An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. Subjects may re-screen after an acute illness is resolved.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV infection) or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of receipt of study vaccine.
- Have taken oral or parenteral (including intraarticular) corticosteroids of any dose within 30 days prior to study vaccination.
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Have taken high-dose dose inhaled corticosteroids within 30 days prior to study vaccination.
- High-dose defined using the inhaled high-dose reference chart.
- Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
- Current or past history of alcohol or drug abuse in the last 5 years.
- Subjects with autoimmune disorders, chronic inflammatory disorders or neurological disorders with a potential autoimmune correlation.
- Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
- Have received any antiviral within 3 days of study vaccination
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History of myocarditis, pericarditis, cardiomyopathy, transient ischemic attack or stroke, myocardial infarction, angina, coronary artery disease, congestive heart failure, clinically significant arrhythmia.
- Including any arrhythmia requiring medication, treatment, or clinical follow-up.
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Electrocardiogram (ECG) with clinically significant findings.
- Clinically significant findings include the following:
- Conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS = / > 120 ms, PR interval = / > 210 ms, any second- or third-degree atrioventricular block, or prolongation of the QT interval corrected according to Bazett's formula [QTcB] [> 450 ms]).
- Significant repolarization (ST-segment or T-wave) abnormality.
- Significant atrial or ventricular arrhythmia; frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, 2 premature ventricular contractions in a row).
- ST-elevation consistent with ischemia or evidence of past or evolving myocardial infarction
- A diagnosis of Type I or II diabetes. (A history of isolated gestational diabetes is not an exclusion criterion).
- Current employee or staff paid entirely or partially by the contract for this trial, or staff who are supervised by the PI or Sub-Investigators.
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Any condition that would, in the opinion of the Site Investigator or appropriate sub-investigator, is a contraindication to study participation.
- Including acute or chronic (persisting for at least 90 days) clinically significant medical disease or condition, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583606
United States, Ohio | |
Cincinnati Children's Hospital Medical Center - Infectious Diseases | |
Cincinnati, Ohio, United States, 45229-3039 |
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT03583606 |
Other Study ID Numbers: |
14-0092 HHSN272201300016I |
First Posted: | July 11, 2018 Key Record Dates |
Last Update Posted: | July 20, 2020 |
Last Verified: | July 15, 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Adenovirus vector Ebola Virus Immunogenicity Non-Human Primates Vaccination/Challenge Studies |
Phase 1 Reactogenicity Safety Zaire ebolavirus vaccine |
Hemorrhagic Fever, Ebola Hemorrhagic Fevers, Viral RNA Virus Infections |
Virus Diseases Filoviridae Infections Mononegavirales Infections |