Clinical Trial: Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Tolerability of a Candidate Bioconjugate Vaccine Against Shigella Flexneri 2a When Administered to Adult Volunteers
Brief Summary:
This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing.
30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.
Detailed Summary:
A total of 30 subjects will be randomly assigned to one of 3 different arms in order to evaluate the safety, tolerability and immunogenicity of a candidate vaccine, formulated with or without adjuvant, and the outcome compared to a placebo control group.
For each active treatment group, 12 subjects will be injected twice with 10 μg Flexyn2a candidate vaccine 4 weeks apart. A control group with 6 subjects will be injected following the same schedule with a placebo solution.
Sponsor: LimmaTech Biologics AG
Current Primary Outcome: Occurrence and severity of adverse events [ Time Frame: until Day 56 ]
Original Primary Outcome:
- Occurrence of adverse events [ Time Frame: until Day 56 ]Number of local site injection and general adverse events will be collected and compared between the different arms of the study
- Severity of the adverse events [ Time Frame: unitl Day 56 ]Severity of the local site injection and general adverse events will be collected and compared between the different arms of the study
Current Secondary Outcome:
- Evaluation of antigen-specific antibodies between baseline (D0) and after injection for all groups. [ Time Frame: until Day 56 ]Immunogenicity will be evaluated after the first and second injection and compared to pre-immune levels
- Evaluation of antigen-specific antibodies between subjects receiving the candidate vaccine with and without adjuvant [ Time Frame: until Day 56 ]Immunogenicity will be compared between subjects receiving candidate vaccine with and without adjuvant after the first and second injection
Original Secondary Outcome: Evaluation of antigen-specific antibodies between baseline (D0) and after injection for all groups. [ Time Frame: until Day 56 ]
Information By: LimmaTech Biologics AG
Dates:
Date Received: February 23, 2015
Date Started: February 2015
Date Completion:
Last Updated: December 21, 2015
Last Verified: December 2015