SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers

Phase 1

Completed

• Conditions: Shigellosis; Bacillary Dysentery
• Interventions: Biological: SF2a-TT15 vaccine + adjuvant; Biological: Placebo; Biological: SF2a-TT15 vaccine; Biological: Placebo + adjuvant

• Registration Number: NCT02797236
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-13
• Study Start: 2016-09
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vaccine dose 1+ adjuvant	SF2a-TT15 vaccine + adjuvant	SF2a-TT15 vaccine, 2 μg + alum
vaccine dose 2 + adjuvant	SF2a-TT15 vaccine + adjuvant	SF2a-TT15 vaccine, 10 μg + alum
Placebo	Placebo	Tris buffer
vaccine dose 2	SF2a-TT15 vaccine	SF2a-TT15 vaccine, 10 μg
vaccine dose 1	SF2a-TT15 vaccine	SF2a-TT15 vaccine, 2 μg
Placebo + adjuvant	Placebo + adjuvant	Tris buffer + Alum

Primary Outcome Measures

Name	Time	Method
Adverse Event	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

Name	Time	Method
Immunogenicity - humoral Immune response	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

Trial Locations

Locations (1)

Tel Aviv Souraski Medical Center; 🇮🇱 Tel Aviv, Israel