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

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Brief Title

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

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.

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 will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.
    

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, 9 receiving placebo).
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions.

Secondary Outcome

 Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgA Antibodies for S. Typhi LPS.

Condition

Typhoid

Intervention

Dose of 5.0 x 10^9 CFU (Cohort 1)

Study Arms / Comparison Groups

 M01ZH09 Vaccine Candidate Cohort 1
Description:  Dose of 5.0 x 10^9 colony forming units (CFU) S. typhi (Ty2 aroC-ssaV-) ZH9 or placebo, administered as a single, oral dose

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

187

Start Date

May 2008

Completion Date

December 2008

Primary Completion Date

December 2008

Eligibility 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
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Stephen Lockhart, DM, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00679172

Organization ID

MS01.13


Responsible Party

Sponsor

Study Sponsor

Emergent BioSolutions


Study Sponsor

Stephen Lockhart, DM, Study Director, Emergent BioSolutions


Verification Date

June 2017