CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
Flexyn2a +1 morebiological
Likely dose
2 doses of 10 μg Flexyn2a intramuscularly, 4 weeks apartAI-extracted
Key inclusion· 4
  • ✓Age 18–50 years (inclusive)
  • ✓Good health without clinically significant medical history or physical examination findings
  • ✓Demonstrated comprehension of protocol with passing score ≥70% on written examination
  • ✓Available for entire study duration including all follow-up visits
Key exclusion· 17
  • ✕Significant medical or psychiatric condition precluding participation
  • ✕HIV, hepatitis B surface antigen, or confirmed hepatitis C antibody positive
  • ✕IgA deficiency (serum IgA <7 mg/dL or below assay limit of detection)
  • ✕Evidence of impaired immune function

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02646371
NCT02646371Phase 2Completed
CompareCT.gov

Phase 2b, Double-blind, Placebo-controlled Efficacy Challenge Study With a Candidate Bioconjugate Vaccine Against Shigella Flexneri 2a

LimmaTech Biologics AG·interventional·Posted Jan 5, 2016·Updated Jan 27, 2021

In Brief

A Phase 2 clinical trial evaluating Flexyn2a and Placebo for Shigellosis. Completed, enrolled 67 participants across 1 site.

Detailed Summary

In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella flexneri 2a strain compared to subjects receiving placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShigellosis
CountriesUnited States
CollaboratorsJohns Hopkins Bloomberg School of Public Health

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 5, 2016
Enrollment StartDec 1, 2015
Primary CompletionSep 1, 2016
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.5 years ago

Interventions

Flexyn2abiological

2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart

Placebobiological

2 doses of TBS solution will be injected intramuscularly 4 weeks apart