TyphoidPhase 2NCT00679172

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

A Phase 2 study testing Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2) and Dose of 1.1 x 10^10 CFU (Cohort 3) in people with Typhoid, run by Emergent BioSolutions at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Typhoid
What is being tested?: Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2) and Dose of 1.1 x 10^10 CFU (Cohort 3)
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 187 participants
Where: 3 sitesUnited States
Study dates: May 2008to Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 18Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

John Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
Unit of Infectious Diseases, University of Vermont College of Medicine
Burlington, Vermont, 05405
Miami Research Associates
South Miami, Florida, 33143

Other trials in United States

About this study

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.

Read the 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).

Conditions: Typhoid
Being tested: Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2), Dose of 1.1 x 10^10 CFU (Cohort 3), Dose of of 1.7 x 10^10 CFU (Cohort 4), Placebo (Cohorts 1-4 pooled)
Medical subject headings: Typhoid Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dose of 5.0 x 10^9 CFU (Cohort 1)Biological
1. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration
Dose of 7.5 x 10^9 CFU (Cohort 2)Biological
1. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration
Dose of 1.1 x 10^10 CFU (Cohort 3)Biological
1. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration
Dose of of 1.7 x 10^10 CFU (Cohort 4)Biological
1. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration
Placebo (Cohorts 1-4 pooled)Other
Excipients only, single dose, oral administration

Study groups in NCT00679172
Study group	Role	What they receive
M01ZH09 Vaccine Candidate Cohort 1	Experimental	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 Receives: Biological: Dose of 5.0 x 10^9 CFU (Cohort 1); Other: Placebo (Cohorts 1-4 pooled)
M01ZH09 Vaccine Candidate Cohort 2	Experimental	Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9 or placebo, administered as a single, oral dose Receives: Biological: Dose of 7.5 x 10^9 CFU (Cohort 2); Other: Placebo (Cohorts 1-4 pooled)
M01ZH09 Vaccine Candidate Cohort 3	Experimental	Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9 or placebo, administered as a single, oral dose Receives: Biological: Dose of 1.1 x 10^10 CFU (Cohort 3); Other: Placebo (Cohorts 1-4 pooled)
M01ZH09 Vaccine Candidate Cohort 4	Experimental	Dose of of 1.7 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9 or placebo, administered as a single, oral dose Receives: Biological: Dose of of 1.7 x 10^10 CFU (Cohort 4); Other: Placebo (Cohorts 1-4 pooled)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions.
Number and proportion of subjects reporting suspected unexpected serious adverse reactions (SUSARs).
Measured: From start of dosing to 28 days post-dosing.
Number and Proportion of Subjects Experiencing Symptomatic Fever.
Number and proportion of subjects experiencing symptomatic (e.g., chills, rigors, sweating, headache, myalgia etc.) elevated body temperature of 38.0°C or more in the 14 days following dosing.
Measured: From start of dosing to 14 days post-dosing.
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Number of subjects having clinically significant changes in clinical laboratory test parameters.
Measured: From start of dosing to 28 days post-dosing.
Number of Subjects Reporting Treatment-related TEAEs.
Number of subjects having TEAEs considered by the principal investigator to be "possibly" or "probably" related to treatment.
Measured: From start of dosing to 28 days post-dosing.
Number and Proportion of Subjects Experiencing Bacteraemia.
Number and proportion of subjects experiencing a proven bacteraemia attributed to the vaccine strain S. typhi (Ty2 aroC-ssaV-) ZH9.
Measured: From start of dosing to 28 days post-dosing.
Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC-ssaV-) ZH9.
Number of subjects having shedding in stool of S. typhi (Ty2 aroC-ssaV-) ZH9. Subjects were evaluated beyond Day 14 only in Cohort 4.
Measured: Beyond 7 days post-dosing through 14 days post-dosing (Cohorts 1-3) or through 21 days post-dosing (Cohort 4).
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).
Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28 AND/OR increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgG and IgA were assayed using enzyme-linked immunosorbent assay (ELISA).
Measured: From baseline (pre-dose) to Days 14 or 28 (IgG) or to Days 7 or 14 (IgA).

Secondary outcomes (6)

Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgA Antibodies for S. Typhi LPS.
Number and proportion of subjects with increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgA was assayed using ELISA.
Measured: From baseline (pre-dose) to Days 7 or 14.
Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.
Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28. Serum IgG was assayed using ELISA.
Measured: From baseline (pre-dose) to Days 14 or 28.
Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.
Number and proportion of subjects with an increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 7, 14 or 28. Serum IgG was assayed using ELISA.
Measured: From baseline (pre-dose) to Days 7, 14, or 28.
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.
Number and proportion of subjects with ≥ 4 ASCs per 10^6 peripheral blood mononuclear cells (PBMCs) at Day 7 secreting IgA specific for S. typhi LPS (detected by enzyme-linked immunospot assay [ELISPOT]) AND/OR 4-fold increase for serum IgG on Day 28 compared to baseline (assay using endpoint titre ELISA).
Measured: At Day 7 (IgA); and from baseline (pre-dose) to Day 28 (IgG).
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.
Number and proportion of subjects with ≥ 4 ASCs per 10^6 PBMCs at Day 7 secreting IgA specific for S. typhi LPS (detected by ELISPOT).
Measured: Day 7.
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.
Number and proportion of subjects with 4-fold increase for serum IgG on Day 28 compared to baseline (assay using endpoint titre ELISA).
Measured: From baseline (pre-dose) to Day 28.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Dec 2008

First posted16 May 2008 (estimated)
Study startMay 2008
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TyphoidStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 187 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00679172
Sponsor's protocol ID: MS01.13
Status last verified: Mar 2024
First submitted: 14 May 2008
Last updated: 9 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Lyon CE, Sadigh KS, Carmolli MP, Harro C, Sheldon E, Lindow JC, Larsson CJ, Martinez T, Feller A, Ventrone CH, Sack DA, DeNearing B, Fingar A, Pierce K, Dill EA, Schwartz HI, Beardsworth EE, Kilonzo B, May JP, Lam W, Upton A, Budhram R, Kirkpatrick BD. In a randomized, double-blinded, placebo-controlled trial, the single oral dose typhoid vaccine, M01ZH09, is safe and immunogenic at doses up to 1.7 x 10(10) colony-forming units. Vaccine. 2010 Apr 30;28(20):3602-8. doi: 10.1016/j.vaccine.2010.02.017. Epub 2010 Feb 24.
PubMed 20188175

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
Not yet recruitingPhase 2
Curcumin Extract Added to Ciprofloxacin for Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program
Typhoid Carrier, Typhoid Fever
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Active, not recruitingPhase 3
Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
Typhoid
RecruitingPhase 4
CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Typhoid and/or Cholera Vaccination

All Typhoid trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00679172
Acronym / sponsor ID: MS01.13
Conditions: Typhoid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 187 participants (actual)
Lead sponsor: Emergent BioSolutionsIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 16 May 2008 (estimated)
Results: Posted 7 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
M01ZH09 Vaccine Candidate Cohort 1	Experimental	Biological: Dose of 5.0 x 10^9 CFU (Cohort 1), Other: Placebo (Cohorts 1-4 pooled)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
M01ZH09 Vaccine Candidate Cohort 2	Experimental	Biological: Dose of 7.5 x 10^9 CFU (Cohort 2), Other: Placebo (Cohorts 1-4 pooled)Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9 or placebo, administered as a single, oral dose
M01ZH09 Vaccine Candidate Cohort 3	Experimental	Biological: Dose of 1.1 x 10^10 CFU (Cohort 3), Other: Placebo (Cohorts 1-4 pooled)Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9 or placebo, administered as a single, oral dose
M01ZH09 Vaccine Candidate Cohort 4	Experimental	Biological: Dose of of 1.7 x 10^10 CFU (Cohort 4), Other: Placebo (Cohorts 1-4 pooled)Dose of of 1.7 x 10^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9 or placebo, administered as a single, oral dose

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dose of 5.0 x 10^9 CFU (Cohort 1)S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration	Biological	M01ZH09 Vaccine Candidate Cohort 1
Dose of 7.5 x 10^9 CFU (Cohort 2)S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration	Biological	M01ZH09 Vaccine Candidate Cohort 2
Dose of 1.1 x 10^10 CFU (Cohort 3)S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration	Biological	M01ZH09 Vaccine Candidate Cohort 3
Dose of of 1.7 x 10^10 CFU (Cohort 4)S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration	Biological	M01ZH09 Vaccine Candidate Cohort 4
Placebo (Cohorts 1-4 pooled)Excipients only, single dose, oral administration	Other	M01ZH09 Vaccine Candidate Cohort 1, M01ZH09 Vaccine Candidate Cohort 2, M01ZH09 Vaccine Candidate Cohort 3, M01ZH09 Vaccine Candidate Cohort 4

Primary outcome

Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions.
Time frame: From start of dosing to 28 days post-dosing.
Number and proportion of subjects reporting suspected unexpected serious adverse reactions (SUSARs).
Number and Proportion of Subjects Experiencing Symptomatic Fever.
Time frame: From start of dosing to 14 days post-dosing.
Number and proportion of subjects experiencing symptomatic (e.g., chills, rigors, sweating, headache, myalgia etc.) elevated body temperature of 38.0°C or more in the 14 days following dosing.
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Time frame: From start of dosing to 28 days post-dosing.
Number of subjects having clinically significant changes in clinical laboratory test parameters.
Number of Subjects Reporting Treatment-related TEAEs.
Time frame: From start of dosing to 28 days post-dosing.
Number of subjects having TEAEs considered by the principal investigator to be "possibly" or "probably" related to treatment.
Number and Proportion of Subjects Experiencing Bacteraemia.
Time frame: From start of dosing to 28 days post-dosing.
Number and proportion of subjects experiencing a proven bacteraemia attributed to the vaccine strain S. typhi (Ty2 aroC-ssaV-) ZH9.
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).
Number of subjects having shedding in stool of S. typhi (Ty2 aroC-ssaV-) ZH9. Subjects were evaluated beyond Day 14 only in Cohort 4.
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).
Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28 AND/OR increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgG and IgA were assayed using enzyme-linked immunosorbent assay (ELISA).

6 secondary outcomes

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.
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.
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.
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).
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.
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.

Results and safety

Results posted to the registry on 7 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
M01ZH09 Vaccine Candidate Cohort 1	37	36
M01ZH09 Vaccine Candidate Cohort 2	38	37
M01ZH09 Vaccine Candidate Cohort 3	36	35
M01ZH09 Vaccine Candidate Cohort 4	39	38
Pooled Placebo	37	37

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

Time frame: From start of dosing to 28 days post-dosing.. Count of participants. Unit: Participants

Measure	M01ZH09 Vaccine Candidate Cohort 1 n = 37	M01ZH09 Vaccine Candidate Cohort 2 n = 38	M01ZH09 Vaccine Candidate Cohort 3 n = 36	M01ZH09 Vaccine Candidate Cohort 4 n = 39	Pooled Placebo n = 37
Value	0	0	0	0	0

Population analysed: Safety Population: All subjects who received a dose of study medication.

Primary outcome: Number and Proportion of Subjects Experiencing Symptomatic Fever.

Time frame: From start of dosing to 14 days post-dosing.. Count of participants. Unit: Participants

Measure	M01ZH09 Vaccine Candidate Cohort 1 n = 37	M01ZH09 Vaccine Candidate Cohort 2 n = 38	M01ZH09 Vaccine Candidate Cohort 3 n = 36	M01ZH09 Vaccine Candidate Cohort 4 n = 39	Pooled Placebo n = 37
Value	1	0	1	0	0

Population analysed: Safety Population: All subjects who received a dose of study medication.

Primary outcome: Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.

Time frame: From start of dosing to 28 days post-dosing.. Number. Unit: participants

Measure	M01ZH09 Vaccine Candidate Cohort 1 n = 37	M01ZH09 Vaccine Candidate Cohort 4 n = 39	Pooled Placebo n = 37
Alanine aminotransferase	1	0	0
Creatinine	0	0	0
Eosinophils	0	0	0
Haematocrit	0	1	0
Haemoglobin	0	1	0
Lymphocytes	0	0	1
Neutrophils	0	0	1
Platelet Count	0	0	0

Population analysed: Safety Population: All subjects who received a dose of study medication.

Primary outcome: Number of Subjects Reporting Treatment-related TEAEs.

Time frame: From start of dosing to 28 days post-dosing.. Number. Unit: participants

Measure	M01ZH09 Vaccine Candidate Cohort 1 n = 37	M01ZH09 Vaccine Candidate Cohort 2 n = 38	M01ZH09 Vaccine Candidate Cohort 3 n = 36	M01ZH09 Vaccine Candidate Cohort 4 n = 39	Pooled Placebo n = 37
Subjects with possibly related TEAEs	19	12	18	10	15
Subjects with probably related TEAEs	7	10	6	19	9

Population analysed: Safety Population: All subjects who received a dose of study medication.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 28.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
M01ZH09 Vaccine Candidate Cohort 1	0 of 37 (0%)	27 of 37 (73%)	0 of 37
M01ZH09 Vaccine Candidate Cohort 2	0 of 38 (0%)	26 of 38 (68.4%)	0 of 38
M01ZH09 Vaccine Candidate Cohort 3	0 of 36 (0%)	30 of 36 (83.3%)	0 of 36
M01ZH09 Vaccine Candidate Cohort 4	0 of 39 (0%)	33 of 39 (84.6%)	0 of 39
Pooled Placebo	0 of 37 (0%)	31 of 37 (83.8%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20188175Lyon CE, Sadigh KS, Carmolli MP, Harro C, Sheldon E, Lindow JC, Larsson CJ, Martinez T, Feller A, Ventrone CH, Sack DA, DeNearing B, Fingar A, Pierce K, Dill EA, Schwartz HI, Beardsworth EE, Kilonzo B, May JP, Lam W, Upton A, Budhram R, Kirkpatrick BD. In a randomized, double-blinded, placebo-controlled trial, the single oral dose typhoid vaccine, M01ZH09, is safe and immunogenic at doses up to 1.7 x 10(10) colony-forming units. Vaccine. 2010 Apr 30;28(20):3602-8. doi: 10.1016/j.vaccine.2010.02.017. Epub 2010 Feb 24.
Individual participant dataSharing planned: No

Related trials for Typhoid

Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
Not yet recruitingPhase 2
Curcumin Extract Added to Ciprofloxacin for Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program
Typhoid Carrier, Typhoid Fever
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Active, not recruitingPhase 3
Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
Typhoid
RecruitingPhase 4
CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Typhoid and/or Cholera Vaccination

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephen Lockhart, DM study director

Emergent BioSolutions

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions. (time frame: From start of dosing to 28 days post-dosing.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00679172, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.