NCT02797236

Brief Summary

This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

April 18, 2016

Last Update Submit

April 10, 2018

Conditions

ShigellosisBacillary Dysentery

Keywords

Phase Iconjugate vaccineShigella flexneri 2asafetyImmunogenicityHealthy adults

Outcome Measures

Primary Outcomes (1)

  • Adverse Event

    Safety: Occurrence, frequency, severity, and duration of local and systemic adverse events (AEs) including clinically significant laboratory abnormalities, after administration of the SF2a-TT15 vaccine.

    12 months

Secondary Outcomes (1)

  • Immunogenicity - humoral Immune response

    12 months

Study Arms (6)

vaccine dose 1

EXPERIMENTAL

SF2a-TT15 vaccine, 2 μg

Biological: SF2a-TT15 vaccine

vaccine dose 1+ adjuvant

EXPERIMENTAL

SF2a-TT15 vaccine, 2 μg + alum

Biological: SF2a-TT15 vaccine + adjuvant

vaccine dose 2

EXPERIMENTAL

SF2a-TT15 vaccine, 10 μg

Biological: SF2a-TT15 vaccine

vaccine dose 2 + adjuvant

EXPERIMENTAL

SF2a-TT15 vaccine, 10 μg + alum

Biological: SF2a-TT15 vaccine + adjuvant

Placebo

PLACEBO COMPARATOR

Tris buffer

Biological: Placebo

Placebo + adjuvant

PLACEBO COMPARATOR

Tris buffer + Alum

Biological: Placebo + adjuvant

Interventions

SF2a-TT15 vaccineBIOLOGICAL
vaccine dose 1vaccine dose 2
SF2a-TT15 vaccine + adjuvantBIOLOGICAL
vaccine dose 1+ adjuvantvaccine dose 2 + adjuvant
PlaceboBIOLOGICAL
Placebo
Placebo + adjuvantBIOLOGICAL
Placebo + adjuvant

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
  • Negative human leukocyte antigen (HLA) -B27 and no history of reactive arthritis
  • Negative HIV, Hepatitis B and Hepatitis C serology tests.
  • Blood levels of Shigella flexneri 2a LPS IgG antibodies ≤ percentile 80
  • No known history of alcohol abuse

You may not qualify if:

  • Subjects with a history of clinically significant gastrointestinal disorders or with any history of frequent diarrhea, nausea or emesis, regardless of etiology.
  • Individuals with immunosuppressive diseases or under immunosuppressive therapy
  • History of culture-proven S. flexneri.
  • Individuals who have household contact with/and /or intimate exposure to an individual with laboratory confirmed S. flexneri.
  • Having travelled in countries/areas highly endemic for S. flexneri within 3 months prior to enrolment.
  • Previous participation in any study in which a Shigella-vaccine candidate was administered.
  • Known contraindication, hypersensitivity and/or allergy to the investigational product or its excipients.
  • Known hypersensitivity and/or allergy to any drug or vaccine
  • Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Souraski Medical Center

Tel Aviv, Israel

Location

Related Publications (1)

  • Cohen D, Atsmon J, Artaud C, Meron-Sudai S, Gougeon ML, Bialik A, Goren S, Asato V, Ariel-Cohen O, Reizis A, Dorman A, Hoitink CWG, Westdijk J, Ashkenazi S, Sansonetti P, Mulard LA, Phalipon A. Safety and immunogenicity of a synthetic carbohydrate conjugate vaccine against Shigella flexneri 2a in healthy adult volunteers: a phase 1, dose-escalating, single-blind, randomised, placebo-controlled study. Lancet Infect Dis. 2021 Apr;21(4):546-558. doi: 10.1016/S1473-3099(20)30488-6. Epub 2020 Nov 10.

    PMID: 33186516DERIVED

MeSH Terms

Conditions

Dysentery, Bacillary

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsDysenteryGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

June 13, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

IL(1)