Phase 2
N=187
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
Typhoid
Bottom Line
View on ClinicalTrials.gov: NCT00679172 ↗Enrolled (actual)
187
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions. — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 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) (Biological); Placebo (Cohorts 1-4 pooled) (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emergent BioSolutions
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions. |
0; 0; 0; 0; 0 | — |
| PRIMARY Number and Proportion of Subjects Experiencing Symptomatic Fever. |
1; 0; 1; 0; 0 | — |
| PRIMARY Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters. |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting Treatment-related TEAEs. |
19; 12; 18; 10; 15; 7 | — |
| PRIMARY Number and Proportion of Subjects Experiencing Bacteraemia. |
0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC-ssaV-) ZH9. |
1; 0; 1; 1; 0; 0 | — |
| 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). |
32; 35; 32; 38; 6 | — |
| SECONDARY Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgA Antibodies for S. Typhi LPS. |
31; 35; 30; 38; 1 | — |
| SECONDARY Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS. |
25; 30; 31; 33; 7 | — |
| SECONDARY Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS. |
25; 30; 31; 33; 7 | — |
| 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. |
36; 0 | — |
| 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. |
35; 0 | — |
| 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. |
14; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00679172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.