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SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT02797236
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

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.

Condition or disease Intervention/treatment Phase
Shigellosis Bacillary Dysentery Biological: SF2a-TT15 vaccine Biological: SF2a-TT15 vaccine + adjuvant Biological: Placebo Biological: Placebo + adjuvant Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : September 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797236


Locations
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Israel
Tel Aviv Souraski Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Institut Pasteur

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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT02797236     History of Changes
Other Study ID Numbers: 2015-060
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Keywords provided by Institut Pasteur:
Phase I
conjugate vaccine
Shigella flexneri 2a
safety
Immunogenicity
Healthy adults
Additional relevant MeSH terms:
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Dysentery, Bacillary
Dysentery
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs