Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 18, 2016
First Posted Date  ICMJE June 13, 2016
Last Update Posted Date April 11, 2018
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02797236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers
Official Title  ICMJE 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
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.

  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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Shigellosis
  • Bacillary Dysentery
Intervention  ICMJE
  • Biological: SF2a-TT15 vaccine
  • Biological: SF2a-TT15 vaccine + adjuvant
  • Biological: Placebo
  • Biological: Placebo + adjuvant
Study Arms  ICMJE
  • Experimental: vaccine dose 1
    SF2a-TT15 vaccine, 2 μg
    Intervention: Biological: SF2a-TT15 vaccine
  • Experimental: vaccine dose 1+ adjuvant
    SF2a-TT15 vaccine, 2 μg + alum
    Intervention: Biological: SF2a-TT15 vaccine + adjuvant
  • Experimental: vaccine dose 2
    SF2a-TT15 vaccine, 10 μg
    Intervention: Biological: SF2a-TT15 vaccine
  • Experimental: vaccine dose 2 + adjuvant
    SF2a-TT15 vaccine, 10 μg + alum
    Intervention: Biological: SF2a-TT15 vaccine + adjuvant
  • Placebo Comparator: Placebo
    Tris buffer
    Intervention: Biological: Placebo
  • Placebo Comparator: Placebo + adjuvant
    Tris buffer + Alum
    Intervention: Biological: Placebo + adjuvant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2016)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02797236
Other Study ID Numbers  ICMJE 2015-060
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Pasteur
Study Sponsor  ICMJE Institut Pasteur
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Pasteur
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP