Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT04723602
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2020-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults
Sponsor:
Albert B. Sabin Vaccine Institute
Organization:
Study Overview
Official Title:
Phase 1b Trial to Evaluate Safety, Tolerability and Immune Responses of 2 Monovalent Chimpanzee Adenoviral Vectored Filovirus (Ebola-S and Marburg) Vaccines to Healthy Adults, Collection of Plasma/Serum for the Purposes of Assay Development
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
• 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: