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SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers

Primary Purpose

Shigellosis, Bacillary Dysentery

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
SF2a-TT15 vaccine
SF2a-TT15 vaccine + adjuvant
Placebo
Placebo + adjuvant
Sponsored by
Institut Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shigellosis focused on measuring Phase I, conjugate vaccine, Shigella flexneri 2a, safety, Immunogenicity, Healthy adults

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Sites / Locations

  • Tel Aviv Souraski Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

vaccine dose 1

vaccine dose 1+ adjuvant

vaccine dose 2

vaccine dose 2 + adjuvant

Placebo

Placebo + adjuvant

Arm Description

SF2a-TT15 vaccine, 2 μg

SF2a-TT15 vaccine, 2 μg + alum

SF2a-TT15 vaccine, 10 μg

SF2a-TT15 vaccine, 10 μg + alum

Tris buffer

Tris buffer + Alum

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Immunogenicity - humoral Immune response
Serum antibody response (IgG IgM, IgA) to S. flexneri 2a LPS, following the administration of the various vaccine doses and antibody secreting cells to S. flexneri 2a LPS, following the administration of the various vaccine doses

Full Information

First Posted
April 18, 2016
Last Updated
April 10, 2018
Sponsor
Institut Pasteur
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1. Study Identification

Unique Protocol Identification Number
NCT02797236
Brief Title
SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers
Official Title
A Phase I Dose Escalation Study to Assess the Safety and Immunogenicity of the SF2a-TT15 Conjugate Vaccine Against S. Flexneri 2a in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Subjects will be assigned to one of two cohorts. Cohort 1 will receive the lower dose of 2 μg vaccine (with or without alum adjuvant) or matching placebo. Cohort 2 will receive the higher dose of 10 μg vaccine (with or without alum adjuvant) or matching placebo. Eligible subjects will be randomized to receive the 2 μg dose or 10 µg without or with alum or matching placebo, at a ratio of 3:1, as three single IM injections. There will be an interval of 28(±3) days) between each treatment. The study will be conducted in a stepwise approach in which a "Pioneer" Group of 2 subjects (one receiving the active vaccine and one receiving the matching placebo) will receive the first injection. These subjects will remain in-house for a 24-hours medical observation after the first injection (not required in the subsequent injections) Once it has been established that there are no safety concerns in the non-adjuvanted "Pioneer" Groups (and after no less than 48 hrs), the next "Pioneer" group (one subject receiving adjuvanted 2 μg vaccine and one receiving the matching alum placebo) will be injected. If no safety concerns are raised in this group also, after no less than 48 hrs, the rest of the subjects may receive the first injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shigellosis, Bacillary Dysentery
Keywords
Phase I, conjugate vaccine, Shigella flexneri 2a, safety, Immunogenicity, Healthy adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vaccine dose 1
Arm Type
Experimental
Arm Description
SF2a-TT15 vaccine, 2 μg
Arm Title
vaccine dose 1+ adjuvant
Arm Type
Experimental
Arm Description
SF2a-TT15 vaccine, 2 μg + alum
Arm Title
vaccine dose 2
Arm Type
Experimental
Arm Description
SF2a-TT15 vaccine, 10 μg
Arm Title
vaccine dose 2 + adjuvant
Arm Type
Experimental
Arm Description
SF2a-TT15 vaccine, 10 μg + alum
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tris buffer
Arm Title
Placebo + adjuvant
Arm Type
Placebo Comparator
Arm Description
Tris buffer + Alum
Intervention Type
Biological
Intervention Name(s)
SF2a-TT15 vaccine
Intervention Type
Biological
Intervention Name(s)
SF2a-TT15 vaccine + adjuvant
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Type
Biological
Intervention Name(s)
Placebo + adjuvant
Primary Outcome Measure Information:
Title
Adverse Event
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Immunogenicity - humoral Immune response
Description
Serum antibody response (IgG IgM, IgA) to S. flexneri 2a LPS, following the administration of the various vaccine doses and antibody secreting cells to S. flexneri 2a LPS, following the administration of the various vaccine doses
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria 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 Exclusion criteria 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.
Facility Information:
Facility Name
Tel Aviv Souraski Medical Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
33186516
Citation
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.
Results Reference
derived

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SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers

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