Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT04723602
Brief 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
Study:
NCT04723602
Study Brief:
Protocol Section:
NCT04723602