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Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
This study is currently recruiting participants.
Verified by Emergent BioSolutions, July 2008
Sponsored by: Emergent BioSolutions
Information provided by: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT00679172
  Purpose

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.


Condition Intervention Phase
Typhoid
Biological: M01ZH09
Other: Placebo
Phase II

MedlinePlus related topics: Fever
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title: 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.

Further study details as provided by Emergent BioSolutions:

Primary Outcome Measures:
  • Safety (including the proportion of subjects reporting adverse events (AEs) and serious adverse events (SAEs)). [ Time Frame: From day of dosing to 28 days post-dosing under double-blind conditions with 3 month open follow-up ] [ Designated as safety issue: No ]
  • Immunogenicity (level of IgG and IgA antibodies for Salmonella typhi lipopolysaccharide post-dosing, in comparison to baseline levels). [ Time Frame: Days 7, 14 and 28 post-dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity (Number of cells secreting IgA antibodies for Salmonella typhi lipopolysaccharide) [ Time Frame: Day 7 post-dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1.: Experimental Biological: M01ZH09
Live attenuated typhoid vaccine, single dose, oral administration
2: Placebo Comparator Other: Placebo
Excipients only

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679172

Contacts
Contact: Ron Budhram +44 (0)118 944 3300 clindev@ebse.com

Locations
United States, Florida
Miami Research Associates Recruiting
South Miami, Florida, United States, 33143
Contact: Eric Sheldon     305-279-0015 ext 4223     esheldon@miamiresearch.com    
Principal Investigator: Eric Sheldon            
United States, Maryland
John Hopkins Bloomberg School of Public Health Recruiting
Baltimore, Maryland, United States, 21205
Contact: Clayton Harro     410-614-4937     charro@jhsph.edu    
Principal Investigator: Clayton Harro            
United States, Vermont
Unit of Infectious Diseases, University of Vermont College of Medicine Recruiting
Burlington, Vermont, United States, 05405
Contact: Beth Kirkpatrick     802-656-5822     Beth.kirkpatrick@uvm.edu    
Principal Investigator: Beth Kirkpatrick            
Sponsors and Collaborators
Emergent BioSolutions
Investigators
Study Director: Stephen Lockhart, DM Emergent BioSolutions
  More Information

Responsible Party: Emergent BioSolutions ( Stephen Lockhart )
Study ID Numbers: MS01.13
Study First Received: May 14, 2008
Last Updated: July 25, 2008
ClinicalTrials.gov Identifier: NCT00679172  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Bacterial Infections
Fever
Enterobacteriaceae Infections
Salmonella Infections
Typhoid
Healthy
Typhoid fever
Typhoid Fever
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on January 15, 2009