Ignite Creation Date:
2024-05-06 @ 2:25 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02034500
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2014-01-02
Brief Title:
Evaluate a New Shigella Sonnei Vaccine Administered Either by Intradermal Intranasal or Intramuscular Route 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 Placebo Controlled Single Center Dose Escalation Study to Evaluate the Safety and Immunogenicity of 3 Vaccinations With Shigella Sonnei Vaccine 1790GAHB Administered Either by Intradermal Intranasal or Intramuscular Route in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2016-06
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 a candidate vaccine against Shigella sonnei 1790GAHB vaccine when administered at different dosages by different routes intradermally intranasally or intramuscularly 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 52 eligible subjects will be assigned to one of three sequential cohorts as follows
Cohort A 01 μg ID and 5 μg IN Cohort B 1 μg ID and 20 μg IN Cohort C 10 μg ID 80 μg IN and 5 μg IM 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 Specifically for IN and ID administration routes 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
Cohort A 01 μg ID and 5 μg IN Cohort B 1 μg ID and 20 μg IN Cohort C 10 μg ID 80 μg IN and 5 μg IM 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 Specifically for IN and ID administration routes 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