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
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
32
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.
Oklahoma Blood Institute (OBI)
Oklahoma City, Oklahoma, United States
Safety of Ebola and Marburg vaccines assessed by clinical observation.
Safety of Ebola and Marburg vaccines, as seen in local reactogenicity signs and symptoms with diary questionnaire card.
Time frame: 7 Days
Safety of Ebola and Marburg vaccines assessed by clinical observation.
Safety of Ebola and Marburg vaccines, as seen in systemic reactogenicity signs and symptoms with diary questionnaire card.
Time frame: 7 Days
Safety of Ebola and Marburg vaccines assessed by change from baseline in levels of Complete Blood Count (CBC).
Safety of Ebola and Marburg vaccines assessed by change in levels of Complete Blood Count (CBC) w/differential count as laboratory measures of safety from baseline.
Time frame: 6 months
Safety of Ebola and Marburg vaccines assessed by change from baseline in levels of Creatinine.
Safety of Ebola and Marburg vaccines assessed by change in levels of Creatinine as laboratory measures of safety from baseline.
Time frame: 6 months
Safety of Ebola and Marburg vaccines assessed by change from baseline in levels of Alanine Transaminase (ALT).
Safety of Ebola and Marburg vaccines assessed by change in levels of Alanine Transaminase (ALT) as laboratory measures of safety from baseline.
Time frame: 6 months
Safety of Ebola and Marburg vaccines assessed by adverse experiences.
Safety of Ebola and Marburg vaccines assessed by adverse events of all severities (Mild, moderate, and severe)
Time frame: 28 days
Safety of Ebola and Marburg vaccines assessed by serious adverse experiences.
Safety of Ebola and Marburg vaccines assessed by serious adverse events of all severities (Mild, moderate, and severe)
Time frame: 6 months
Evaluation of antibody response to cAd3-EBO-S and cAd3 Marburg vaccines
Immunogenicity of the Ebola and Marburg vaccines as measured by antigen GP-specific ELISA
Time frame: Measured at Day 1, 15, 22, 29, 36, 43, 50, 57, and 64
Collection of sufficient post-vaccination plasma to support further development of filovirus assays.
20 L of plasma per vaccine group (N=2) will be collected for the purpose of assay development. 800 mL of plasma will be collected at Day 29. Thereafter, plasma collections will be up to approximately 600 mL. Participants may donate up to 6 total times and all collections will be done within the limits of the FDA approved instructions for use for the Fenwal Alyx collection device.
Time frame: May be collected at Day 29, 36, 43, 50, 57 and/or 64
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