NCT04349553

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Prokarium Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Enteric Fever

Interventions

Type	Name	Description
BIOLOGICAL	ZH9PA and ZH9	150mL vaccine for oral administration
BIOLOGICAL	Placebo	150mL vaccine for oral administration
BIOLOGICAL	ZH9PA	150mL vaccine for oral administration

Timeline

• Start date: 2019-12-16
• Primary completion: 2020-09-28
• Completion: 2021-02-15
• First posted: 2020-04-16
• Last updated: 2025-08-17
• Results posted: 2025-08-17

Locations

1 site across 1 country: United Kingdom