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Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults

A Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Study to Determine the Immunogenicity, Safety and Tolerability of S. Typhi (Ty2 aroC-ssaV-) ZH9 at Doses of 5.0 x 10E9 CFU, 7.5 x 10E9 CFU, 1.1 x 10E10 and 1.7 x 10E10 CFU and 1.7 x 10E10 CFU, Following Oral Administration to Healthy, Typhoid Vaccine naïve Subjects in the USA.

NCT00679172•Emergent BioSolutions

View on ClinicalTrials.gov

Summary

This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility. The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.

Detailed Description

This was a randomised, double-blind, placebo-controlled, single dose, dose escalation study with 4 dosing cohorts. Within each cohort, 45 evaluable subjects were planned (36 subjects receiving M01ZH09, 9 receiving placebo).

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•healthy adult subjects aged 18 to 50 years inclusive, who are able and willing to give informed consent, following a detailed explanation of participation in protocol
•available for the duration of the study and available for scheduled and potential additional visits

Exclusion Criteria

•women who are pregnant, breast-feeding or of childbearing potential and unwilling to use a reliable method of contraception throughout the study period
•history of anaphylactic shock following vaccination by any route have phenylketonuria
•hypersensitivity to any component of the vaccine or are hypersensitive to two of the following antibiotics: ciprofloxacin, azithromycin, ampicillin, trimethoprim sulfamethoxazole
•received antibiotic medication within 14 days prior to dosing
•received any vaccine within 4 weeks prior to dosing or plan to receive a vaccine within 4 weeks after dosing
•received any vaccine against Salmonella typhi (licensed or investigational) or ever suffered from typhoid fever
•subjects who test positive for hepatitis B, hepatitis C, HIV or human leucocyte antigen B-27
•known or suspected history of liver or active gall bladder disease, ongoing gastro-intestinal disease or abnormality
•commercial food handlers or health care workers with direct contact with high risk patients or who have household contacts with immuno-compromised individuals, pregnant women or children less than 2 years of age
•subjects who have a clinically significant amount of protein or haemoglobin in their urine or abnormality of their haematology or serum biochemistry parameters
+8 more criteria

Locations (3)

Miami Research Associates

South Miami, Florida, United States

John Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Unit of Infectious Diseases, University of Vermont College of Medicine

Burlington, Vermont, United States

Key Dates

Start Date

May 1, 2008

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

April 9, 2024

Enrollment

187

ACTUAL participants

Conditions

Typhoid

Interventions

Dose of 5.0 x 10^9 CFU (Cohort 1)

BIOLOGICAL

Dose of 7.5 x 10^9 CFU (Cohort 2)

BIOLOGICAL

Dose of 1.1 x 10^10 CFU (Cohort 3)

BIOLOGICAL

Dose of of 1.7 x 10^10 CFU (Cohort 4)

BIOLOGICAL

Placebo (Cohorts 1-4 pooled)

OTHER

CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults

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Typhoid Vaccination

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COMPLETEDNA

Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy

NCT06546982

Typhoid Fever

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COMPLETEDPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults

Inclusion Criteria

Exclusion Criteria

CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults

Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy

Non-inferiority Trial of Locally Manufactured Typhoid Conjugate Vaccine 'Typhocon' in Bangladesh

Evaluation Study of DPP® Typhoid Assay

Co-administration Study of OCV, TCV and MR

Understanding Typhoid Disease After Vaccination