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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

May 14, 2008
January 30, 2009
May 2008
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00679172 on ClinicalTrials.gov Archive Site
Immunogenicity (Number of cells secreting IgA antibodies for Salmonella typhi lipopolysaccharide) [ Time Frame: Day 7 post-dosing ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Typhoid
  • Biological: M01ZH09
    Live attenuated typhoid vaccine, single dose, oral administration
  • Other: Placebo
    Excipients only
  • Experimental: 1.
    Intervention: Biological: M01ZH09
  • Placebo Comparator: 2
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00679172
MS01.13
No
Stephen Lockhart, Emergent BioSolutions
Emergent BioSolutions
Not Provided
Study Director: Stephen Lockhart, DM Emergent BioSolutions
Emergent BioSolutions
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP