SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers

Shigellosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797236
• Other study ID #: 2015-060
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2016
• Last updated: April 10, 2018
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacillary Dysentery
• Dysentery
• Dysentery, Bacillary
• Shigellosis

Intervention

Biological:
• SF2a-TT15 vaccine

• SF2a-TT15 vaccine + adjuvant

• Placebo

• Placebo + adjuvant

Locations

Country	Name	City	State
Israel	Tel Aviv Souraski Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Institut Pasteur

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 months