Status:
COMPLETED
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
Lead Sponsor:
Emergent BioSolutions
Conditions:
Typhoid
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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 w...
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...
Eligibility Criteria
Inclusion
- 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
- 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
- impairment of immune function or those receiving or have received cytotoxic drugs in the 6 months prior to study entry
- subjects who use antacids, proton pump inhibitors or H2 blockers on a regular basis or have consumed proton pump inhibitors or H2 blockers within 24 hours prior to dosing
- acute infections (including fever of 37.5 degrees Celsius or greater) on the day of dosing.
- subjects with chronic disease (e.g Crohn's disease, inflammatory bowel disease, diabetes) who cannot withstand a 3 hour fast
- substance abuse or a history of substance abuse that might interfere with participation in the study
- body mass index (BMI) is less than 19 or greater than 34 kg per m2
- clinically significant medical condition that precludes participation in the study
- subjects who have participated in an interventional clinical trial within 60 days of dosing
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00679172
Start Date
May 1 2008
End Date
December 1 2008
Last Update
April 9 2024
Active Locations (3)
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1
Miami Research Associates
South Miami, Florida, United States, 33143
2
John Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
3
Unit of Infectious Diseases, University of Vermont College of Medicine
Burlington, Vermont, United States, 05405