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Understanding Typhoid Disease After Vaccination

NCT01405521 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-05-06

No results posted yet for this study

Summary

Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.

Conditions

  • Typhoid Fever
  • Enteric Fever
  • Typhoid

Interventions

BIOLOGICAL

Vaccine placebo (excipients only)

single oral dose,

BIOLOGICAL

Ty21a

3 oral doses, alternate days

BIOLOGICAL

M10ZH09 vaccine

single oral dose

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • University of Maryland

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Andrew J Pollard · Oxford Vaccine Group, Department of Paediatrics, University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-07
Primary Completion
2015-12-31
Completion
2022-05-06

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01405521 on ClinicalTrials.gov