Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults
Condition: Ebola Virus Disease; Marburg Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola; Marburg Virus Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      • To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when
      administered Intramuscular (IM) at a dose of 1 x 10^11 particle units (PU) to healthy adults.

      Secondary Objectives:

        -  To evaluate the antibody response to Monovalent Chimpanzee Adenoviral Vectored Filovirus
           Ebola-S (cAd3-EBO-S) and Monovalent Chimpanzee Adenoviral Vectored Filovirus (Marburg)
           (cAd3 Marburg) vaccines as assessed by antigen glycoprotein (GP) specific (enzyme-linked
           immunosorbent assay) ELISA

        -  To collect sufficient post-vaccination plasma to support further development of
           filovirus assays
    

Detailed description: 
      Primary Endpoints: Safety

      Assessment of product safety will include clinical observation and monitoring of clinical
      chemistry and hematology parameters. Safety will be closely monitored after injection and
      evaluated through Day 99 and one additional safety follow-up telephone call on Day 181 (± 14
      Days). The following parameters will be assessed:

        -  Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days
           following the vaccination

        -  Occurrence and severity of solicited systemic reactogenicity signs and symptoms for 7
           days following the vaccination

        -  Change from baseline for safety laboratory measures

        -  Occurrence of adverse events of all severities through 28 days after vaccination

        -  Occurrence of serious adverse events and new chronic medical conditions through the last
           safety follow up call at Day 181(± 14 days)

      Secondary Endpoints :

        -  Antibody levels against vaccines cAd3-EBO-S and cAd3 Marburg as measured by
           enzyme-linked immunosorbent assay (ELISA) on Day 1, 15, 22, 29, 36, 43, 50, 57 and 64

        -  20 Liters of plasma per vaccine group will be collected for the purpose of assay
           development
    

Intervention name(s): cAd3-Marburg; cAd3-EBO-S
Intervention type(s): Biological; Biological
Intervention description(s): A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 1 (N = 16) will receive a single injection of cAd3-Marburg at 1 x 10^11 Particle Units (PU) vaccine.; A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 2 (N = 16) will receive a single injection of cAd3-EBO-S at 1 x 10^11 Particle Units (PU) vaccine.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 cohorts of 16 participants each.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Coronavirus Disease; Creatine phosphokinase; Clinical Research Associate; Contract Research Organization; Division of AIDS; Disseminated Intravascular Coagulation; Diagnostic Lab of Oklahoma; Deoxyribonucleic Acid; Species Zaire Ebolavirus; Electronic Case Report Form; Ethylenediaminetetraacetic Acid; Ebola Hemorrhagic Fever; Enzyme-Linked Immunosorbent Assay; Food and Drug Administration; Ebola Virus Disease; Degrees Fahrenheit; Good Clinical Practices; Good Laboratory Practices; Grams; Glycoprotein; Government and Public Health Solutions; GlaxoSmithKline; Hemagglutinin; Hereditary Angioedema; Hepatitis B Virus; Hepatitis C Virus; Human immunodeficiency virus; Human T-cell Leukemia Lymphoma Virus; Investigator's Brochure; International Council for Harmonisation; International Committee on the Taxonomy of Viruses; Identification; Immunoglobulin G; Immunoglobulin M; Intramuscular(ly); Investigational New Drug; Investigational product; Intravenous; Marburg Virus; Marburg Virus Disease; Marburg hemorrhagic fever; Milliliter; Millimeters of Mercury; Modified Vaccinia Ankara; Nucleic Acid Test; Non-Disclosure Agreement; Non-Human Primate; National Institute of Allergy and Infectious Diseases; National Institutes of Health; Nucleoprotein; Nonsteroidal Anti-Inflammatory Drug; Oklahoma Blood Institute; Office for Human Research Protection; Plasmapheresis Assessment Review Team; Plaque Forming Unit; Physical Exam; Principal Investigator; Post Injection Reactogenicity; Project Manager; Prothrombin Time; Partial Thromboplastin Time; Particle Units; Ravn Virus; Recombinant Human Adenovirus Serotype 5; Species Reston ebolavirus; Ribonucleic Acid; Rapid Plasma Regain; Reverse Transcription Polymerase Chain Reaction; Serious Adverse Event; Severe Acute Respiratory Syndrome Coronavirus 2; Statistical Analysis System; Schedule of Events; Standard Operating Procedure; Serum Separator Tube; Species Sudan Ebolavirus; Suspected, Unexpected and Serious Adverse Reaction; Species Taï Forest Ebolavirus; Technical Resources International, Inc; Universal Donor History Questionnaire; Upper Limit of Normal; Viral Particles; Vaccine Research Center; Vesicular Stomatitis Virus; Variant Creutzfeldt-Jakob Disease; White blood cell; World Health Organization; Western Institutional Review Board; Wild type; Zaire Ebola virus; Acquired Angioedema; Program, Inc.; Human adenovirus Serotype 5; Activities of Daily Living; Adverse Event; Acquired Immunodeficiency Syndrome; Alanine aminotransferase; Assessment of Understanding; Aspartate Aminotransferase; Biomedical Advanced Research and Development Authority; Species Bundibugyo ebolavirus; Blood Establishment Computer System; Body mass index; Blood Urea Nitrogen; Recombinant Chimpanzee Adenovirus Serotype 3; Recombinant Chimpanzee Adenovirus; Recombinant Chimpanzee Adenovirus Serotype 63; Complete blood count; Center for Disease Control and Prevention; Code of Federal Regulations; Confidence Interval; Centimeters; Type 3-Vectored Ebola virus Vaccine; Type 3-Vectored Ebola Sudan Vaccine; Type 3-Vectored Marburg Vaccine