Shigellosis Clinical Trial
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.
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) 0.1 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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02797236 -
SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers
|
Phase 1 | |
| Completed |
NCT04056117 -
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05959616 -
Shigella Sonnei 53G Human Infection Study in Kenyan Adults
|
Phase 1 | |
| Completed |
NCT02445963 -
Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)
|
Phase 1 | |
| Not yet recruiting |
NCT05961059 -
InvaplexAR-Detox and dmLT Adjuvant in the Netherlands and Zambia
|
Phase 1 | |
| Completed |
NCT00485134 -
Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
|
Phase 1/Phase 2 | |
| Completed |
NCT01369927 -
Shigella Sonnel O-SPC/rBRU Conjugate Vaccine
|
Phase 1 | |
| Completed |
NCT01509846 -
Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults
|
Phase 1 | |
| Completed |
NCT02105714 -
Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders
|
N/A | |
| Withdrawn |
NCT01399424 -
Shigella Sonnei OSPC-rDT Conjugate Vaccine
|
Phase 1 | |
| Completed |
NCT00800930 -
Therapeutic Induction of Endogenous Antibiotics
|
Phase 2 | |
| Completed |
NCT00368316 -
Safety, Immunogenicity and Efficacy of Shigella Conjugate Vaccines in 1-4 Year Olds in Israel
|
Phase 3 | |
| Recruiting |
NCT05182749 -
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
|
Phase 1/Phase 2 | |
| Completed |
NCT02388009 -
Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a
|
Phase 1 | |
| Completed |
NCT02017899 -
A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.
|
Phase 1 | |
| Completed |
NCT01069471 -
Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella
|
Phase 1 | |
| Completed |
NCT02646371 -
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
|
Phase 2 | |
| Recruiting |
NCT05156528 -
Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
|
Phase 3 | |
| Completed |
NCT03854929 -
Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery
|
Phase 4 | |
| Recruiting |
NCT05121974 -
Tebipenem Trial in Children With Shigellosis
|
Phase 2 |