Ignite Creation Date:
2024-05-06 @ 2:19 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02017899
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2013-12-17
Brief Title:
A Phase 1 Dose Escalation Study to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults
Sponsor:
GSK Vaccines Institute For Global Health Srl
Organization:
GSK Vaccines Institute For Global Health Srl
Study Overview
Official Title:
A Phase 1 Randomized Observer Blinded Placebo Controlled Single Center Dose Escalation Study to Evaluate the Safety and Immunogenicity of 3 Vaccinations With Shigella Sonnei Vaccine 1790GAHB Administered Intramuscularly in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2018-08
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:
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei 1790GAHB vaccine administered by intramuscular route in healthy adults 18 to 45 years of age at enrollment The safety profile of the 1790GAHB vaccine is evaluated in comparison to that of placebo GAHB-Placebo constituted by an aluminum hydroxide suspension having the same concentration as study vaccine formulations A total of 50 eligible subjects will be assigned to one of five sequential cohorts of 10 subjects each
Within each cohort in an observer-blind fashion subjects will be randomized to receive three vaccinations four weeks apart of either 1790GAHB vaccine at five antigen concentrations or GAHB placebo A Data Safety Monitoring Board will be in place to receive a summary of all safety data obtained during one week follow-up post-first vaccination with the lower dose Based on evaluation of the safety data the Data Safety Monitoring Board will make a recommendation as to whether the next cohort should be vaccinated with higher antigen concentration or not
Expected duration of the study for an individual subject is 9 months Each subject will be followed-up for 6 months after the 3rd vaccination
Within each cohort in an observer-blind fashion subjects will be randomized to receive three vaccinations four weeks apart of either 1790GAHB vaccine at five antigen concentrations or GAHB placebo A Data Safety Monitoring Board will be in place to receive a summary of all safety data obtained during one week follow-up post-first vaccination with the lower dose Based on evaluation of the safety data the Data Safety Monitoring Board will make a recommendation as to whether the next cohort should be vaccinated with higher antigen concentration or not
Expected duration of the study for an individual subject is 9 months Each subject will be followed-up for 6 months after the 3rd vaccination
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None