Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine

Enteric Fever Clinical Trial

Official title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Oral Enteric Fever Vaccine (ZH9 + ZH9PA) in Healthy Participants

Status Completed

Clinical Trial Summary

A Phase 1, randomised, double-blind, placebo-controlled, parallel group study in 45 healthy participants aged 18 to 45 years inclusive.

Clinical Trial Description

This is a Phase I, randomised, double-blind, placebo-controlled, parallel group, single-centre study involving 45 healthy participants. The aim is to evaluate the safety and immunogenicity of Entervax, a combination vaccine against enteric fever comprising Typhi ZH9 (hereafter ZH9) plus an engineered derivative that will provide an immune response to the key antigens (LPS 0:2 and H:a flagella) from S. Paratyphi A (hereafter ZH9PA). ZH9PA has not previously been tested in humans therefore the first two cohorts comprise a dose escalation of ZH9PA and the final cohort comprises a single dose level of the combination of ZH9PA and ZH9. ;

Related Conditions & MeSH terms

• Enteric Fever
• Fever
• Typhoid Fever

• NCT number: NCT04349553
• Study type: Interventional
• Source: Prokarium Ltd
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2019
• Completion date: February 15, 2021