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

NCT02797236 Phase 1 COMPLETED

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

Details

Lead sponsor	Institut Pasteur
Phase	Phase 1
Status	COMPLETED
Enrolment	64
Start date	2016-09
Completion	2017-12

Conditions

• Shigellosis
• Bacillary Dysentery

Interventions

• SF2a-TT15 vaccine
• SF2a-TT15 vaccine + adjuvant
• Placebo
• Placebo + adjuvant

Primary outcomes

• 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.

Countries

Israel