SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers

April 10, 2018 updated by: Institut Pasteur

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be assigned to one of two cohorts.

  1. Cohort 1 will receive the lower dose of 2 μg vaccine (with or without alum adjuvant) or matching placebo.
  2. 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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Souraski Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vaccine dose 1
SF2a-TT15 vaccine, 2 μg
Biological: SF2a-TT15 vaccine
Experimental: vaccine dose 1+ adjuvant
SF2a-TT15 vaccine, 2 μg + alum
Biological: SF2a-TT15 vaccine + adjuvant
Experimental: vaccine dose 2
SF2a-TT15 vaccine, 10 μg
Biological: SF2a-TT15 vaccine
Experimental: vaccine dose 2 + adjuvant
SF2a-TT15 vaccine, 10 μg + alum
Biological: SF2a-TT15 vaccine + adjuvant
Placebo Comparator: Placebo
Tris buffer
Biological: Placebo
Placebo Comparator: Placebo + adjuvant
Tris buffer + Alum
Biological: Placebo + adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity - humoral Immune response
Time Frame: 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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