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 ]

Number and severity of local site injection and general adverse events will be collected and compared between the different arms of the study


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