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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679172
First Posted: May 16, 2008
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Emergent BioSolutions
Results First Submitted: May 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Typhoid
Interventions: Biological: 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)
Other: Placebo (Cohorts 1-4 pooled)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
M01ZH09 Vaccine Candidate Cohort 1 Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
M01ZH09 Vaccine Candidate Cohort 2 Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
M01ZH09 Vaccine Candidate Cohort 3 Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
M01ZH09 Vaccine Candidate Cohort 4 Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
Pooled Placebo Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.

Participant Flow:   Overall Study
    M01ZH09 Vaccine Candidate Cohort 1   M01ZH09 Vaccine Candidate Cohort 2   M01ZH09 Vaccine Candidate Cohort 3   M01ZH09 Vaccine Candidate Cohort 4   Pooled Placebo
STARTED   37   38   36   39   37 
COMPLETED   36   37   35   38   37 
NOT COMPLETED   1   1   1   1   0 
Non-compliance                1                1                0                1                0 
Other not specified                0                0                1                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
M01ZH09 Vaccine Candidate Cohort 1 Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
M01ZH09 Vaccine Candidate Cohort 2 Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
M01ZH09 Vaccine Candidate Cohort 3 Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
M01ZH09 Vaccine Candidate Cohort 4 Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
Pooled Placebo Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
Total Total of all reporting groups

Baseline Measures
   M01ZH09 Vaccine Candidate Cohort 1   M01ZH09 Vaccine Candidate Cohort 2   M01ZH09 Vaccine Candidate Cohort 3   M01ZH09 Vaccine Candidate Cohort 4   Pooled Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   38   36   39   37   187 
Age 
[Units: Participants]
Count of Participants
           
<=18 years      1   2.7%      0   0.0%      1   2.8%      1   2.6%      1   2.7%      4   2.1% 
Between 18 and 65 years      36  97.3%      38 100.0%      35  97.2%      38  97.4%      36  97.3%      183  97.9% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.2  (10.13)   33.1  (10.00)   32.0  (9.99)   31.3  (9.21)   32.3  (10.01)   32.4  (9.79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      18  48.6%      17  44.7%      19  52.8%      19  48.7%      21  56.8%      94  50.3% 
Male      19  51.4%      21  55.3%      17  47.2%      20  51.3%      16  43.2%      93  49.7% 
Region of Enrollment 
[Units: Participants]
           
United States   37   38   36   39   37   187 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions.   [ Time Frame: From start of dosing to 28 days post-dosing. ]

2.  Primary:   Number and Proportion of Subjects Experiencing Symptomatic Fever.   [ Time Frame: From start of dosing to 14 days post-dosing. ]

3.  Primary:   Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.   [ Time Frame: From start of dosing to 28 days post-dosing. ]

4.  Primary:   Number of Subjects Reporting Treatment-related TEAEs.   [ Time Frame: From start of dosing to 28 days post-dosing. ]

5.  Primary:   Number and Proportion of Subjects Experiencing Bacteraemia.   [ Time Frame: From start of dosing to 28 days post-dosing. ]

6.  Primary:   Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC‾ssaV‾) ZH9.   [ Time Frame: Beyond 7 days post-dosing through 14 days post-dosing (Cohorts 1-3) or through 21 days post-dosing (Cohort 4). ]

7.  Primary:   Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG and/or IgA Antibodies for S. Typhi Lipopolysaccharide (LPS).   [ Time Frame: From baseline (pre-dose) to Days 14 or 28 (IgG) or to Days 7 or 14 (IgA). ]

8.  Secondary:   Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgA Antibodies for S. Typhi LPS.   [ Time Frame: From baseline (pre-dose) to Days 7 or 14. ]

9.  Secondary:   Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.   [ Time Frame: From baseline (pre-dose) to Days 14 or 28. ]

10.  Secondary:   Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.   [ Time Frame: From baseline (pre-dose) to Days 7, 14, or 28. ]

11.  Secondary:   Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Number of Antibody Secreting Cells (ASCs) Secreting IgA and/or Fold Change in IgG.   [ Time Frame: At Day 7 (IgA); and from baseline (pre-dose) to Day 28 (IgG). ]

12.  Secondary:   Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Number of ASCs Secreting IgA.   [ Time Frame: Day 7. ]

13.  Secondary:   Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Fold Change in IgG.   [ Time Frame: From baseline (pre-dose) to Day 28. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Tim Babinchak
Organization: Emergent Product Development Gaithersburg
phone: (240) 631-3585


Publications of Results:

Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT00679172     History of Changes
Other Study ID Numbers: MS01.13
First Submitted: May 14, 2008
First Posted: May 16, 2008
Results First Submitted: May 2, 2017
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017