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

This study has been completed.
Sponsor:
Information provided by:
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT00679172
First received: May 14, 2008
Last updated: January 30, 2009
Last verified: January 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


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 ]

Enrollment: 187
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Biological: M01ZH09
Live attenuated typhoid vaccine, single dose, oral administration
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679172

Locations
United States, Florida
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Maryland
John Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
United States, Vermont
Unit of Infectious Diseases, University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
Emergent BioSolutions
Investigators
Study Director: Stephen Lockhart, DM Emergent BioSolutions
  More Information

No publications provided

Responsible Party: Stephen Lockhart, Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT00679172     History of Changes
Other Study ID Numbers: MS01.13
Study First Received: May 14, 2008
Last Updated: January 30, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 22, 2014