Typhoid FeverPhase 2NCT01405521
Understanding Typhoid Disease After Vaccination
A Phase 2 study testing Ty21a and M10ZH09 vaccine in people with Typhoid Fever and Enteric Fever, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid Fever, Enteric Fever, Typhoid
- What is being tested?
- Ty21a and M10ZH09 vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2011to 6 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 - 60 years inclusive and in good health.
- Have an abdominal ultrasound scan result documented demonstrating no evidence of gallbladder pathology.
- Willing to allow their general practitioner and/or hospital consultant (if relevant) and the Health Protection Unit to be notified of participation in the study.
- Agree to refrain from blood donation in the future if diagnosed with typhoid fever.
- Be willing to have 24-hour contact with study staff during the four weeks post-challenge.
Who cannot join
- Have previously received any typhoid vaccine, been resident in a typhoid endemic country for over 6 months, been diagnosed with probable or confirmed typhoid infection or been challenged with Salmonella Typhi or enrolled in a typhoid challenge study.
- Have any known or suspected impairment or alteration of immune function.
- History of significant cardiovascular disease.
- History of significant respiratory disease.
- History of significant endocrine disorder.
- History of significant renal or bladder disease.
Show all 25Show fewer
- History of biliary tract disease.
- History of significant gastrointestinal disease.
- History of significant neurological disease.
- History of significant metabolic disease.
- History of significant haematological diagnosis.
- History of psychiatric illness requiring hospitalisation, current known or suspected drug or alcohol misuse.
- History of significant infectious disease.
- History of non-benign cancer.
- Presence of any implants or prostheses.
- Hypersensitivity to any component of the vaccine or are hypersensitive to two or more of the following antibiotics: ciprofloxacin, azithromycin, ampicillin, trimethoprim sulfamethoxazole.
- Female participant who is pregnant, lactating or who is unwilling to ensure that they or their partner use effective contraception one month prior to vaccination and continue to do so until two negative stool samples obtained a week apart, a minimum of 1 week after completion of antibiotic treatment have been obtained.
- Current occupation involving: clinical or social work with direct contact with young children (defined as those attending pre-school groups, nursery or aged less than 2 years); highly susceptible patients or persons in whom typhoid infection would have particularly serious consequences (i.e. those who are immunocompromised or debilitated); care work involving the elderly.
- Current occupation as a commercial food handler involving the preparation or serving of unwrapped foods not subjected to further heating.
- Household contact with a young child (defined as above).
- Household/close contact who is immunocompromised.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the vaccine/challenge period, at time of enrolment.
- Participants who have taken part in other research involving an investigational product (IMP) within the 30 days prior to enrolment.
- Have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the previous 3 months
- Any other significant disease or disorder which, in the opinion of the investigator, may put the participants at risk because of participation in the study, may influence the result of the study, or affect the participant's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine
Oxford
About this study
Official title: Understanding Typhoid Disease After Vaccination: a Single Centre, Randomised, Doubleblind, Placebo Controlled Study to Evaluate M01ZH09 in a Healthy Adult Challenge Model, Using Ty21a Vaccine as a Positive Control.
Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.
Read the detailed description
Typhoid is a serious infection killing up to 600,000 people every year; it is a frequent cause of fever and hospital admission in areas where disease is common. As the infection is restricted to humans, it should be possible to eliminate typhoid; better vaccines and ways of confirming infection are required in order for this to succeed. We propose to use a recently established human typhoid challenge model in order to evaluate a novel oral vaccine candidate and to develop new methods for diagnosing typhoid.
Although there are vaccines available to prevent typhoid, they offer little protection to populations where typhoid predominates, especially young children. Currently, the effectiveness of vaccines against typhoid cannot be predicted, as measures of protection against typhoid are unknown. As a result, implementation of vaccine programmes in disease endemic regions currently requires large and expensive trials in each new population, significantly delaying programmatic implementation.
We will use a typhoid challenge model to achieve our goal of accelerating the introduction of more effective vaccines into populations with a high burden of disease. Healthy adults will be vaccinated with either a novel oral typhoid vaccine or vaccine-placebo prior to being infected with the bacteria causing typhoid. This will allow us to measure the effectiveness of the vaccine and to identify components of the immune response important in producing protection against infection.
Current methods for confirming typhoid infection are slow and insensitive, particularly in endemic regions where the cost of laboratory equipment is prohibitive. In this project, we will also explore ways to diagnose typhoid, with the aim of developing tests that are quick, reliable and are be cost-effective in resource-poor settings. This would improve individual patient management, and allow accurate measurement of disease burden, which is vital to improve the efforts of vaccine programmes.
- Conditions
- Typhoid Fever, Enteric Fever, Typhoid
- Being tested
- Vaccine placebo (excipients only), Ty21a, M10ZH09 vaccine
- Keywords
- typhoid vaccine M01ZH09, Ty21a typhoid vaccine
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine placebo (excipients only)Biological
single oral dose,
Ty21aBiological
Also called Vivotif
3 oral doses, alternate days
M10ZH09 vaccineBiological
Also called Typhella
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| M01ZH09 vaccine | Experimental | Not described Receives: Biological: M10ZH09 vaccine |
| Vaccine placebo | Placebo comparator | Not described Receives: Biological: Vaccine placebo (excipients only) |
| Ty21a vaccine | Other | Positive control Receives: Biological: Ty21a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of typhoid fever
Typhoid fever defined as development of Gram negative bacteraemia after day 5 or temperature over 38C persisting for 12 hours or more.
Typhoid challenge defined as ingestion of virulent S. Typhi (Quailes strain).
Measured: 2 weeks after typhoid challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study start7 Oct 2011
- Primary completionDec 2015
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Typhoid FeverStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Imperial College London, University of Maryland
- Responsible party
- Sponsor
- Investigators
- Andrew J Pollard, Principal investigator, Oxford Vaccine Group, Department of Paediatrics, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405521
- Sponsor's protocol ID
- OVG 2011/02
- Other IDs
- 2011-000381-35
- Status last verified
- Dec 2020
- First submitted
- 28 Jul 2011
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gibani MM, Voysey M, Jin C, Jones C, Thomaides-Brears H, Jones E, Baker P, Morgan M, Simmons A, Gordon MA, Cerundolo V, Pitzer VE, Angus B, Levine MM, Darton TC, Pollard AJ. The Impact of Vaccination and Prior Exposure on Stool Shedding of Salmonella Typhi and Salmonella Paratyphi in 6 Controlled Human Infection Studies. Clin Infect Dis. 2019 Apr 8;68(8):1265-1273. doi: 10.1093/cid/ciy670.
PubMed 30252031Darton TC, Blohmke CJ, Giannoulatou E, Waddington CS, Jones C, Sturges P, Webster C, Drakesmith H, Pollard AJ, Armitage AE. Rapidly Escalating Hepcidin and Associated Serum Iron Starvation Are Features of the Acute Response to Typhoid Infection in Humans. PLoS Negl Trop Dis. 2015 Sep 22;9(9):e0004029. doi: 10.1371/journal.pntd.0004029. eCollection 2015 Sep.
PubMed 26394303Juel HB, Thomaides-Brears HB, Darton TC, Jones C, Jones E, Shrestha S, Sie R, Eustace A, Galal U, Kurupati P, Van TT, Thieu NTV, Baker S, Blohmke CJ, Pollard AJ. Salmonella Typhi Bactericidal Antibodies Reduce Disease Severity but Do Not Protect against Typhoid Fever in a Controlled Human Infection Model. Front Immunol. 2018 Jan 17;8:1916. doi: 10.3389/fimmu.2017.01916. eCollection 2017.
PubMed 29387052Blohmke CJ, Hill J, Darton TC, Carvalho-Burger M, Eustace A, Jones C, Schreiber F, Goodier MR, Dougan G, Nakaya HI, Pollard AJ. Induction of Cell Cycle and NK Cell Responses by Live-Attenuated Oral Vaccines against Typhoid Fever. Front Immunol. 2017 Oct 12;8:1276. doi: 10.3389/fimmu.2017.01276. eCollection 2017.
PubMed 29075261Barton A, Hill J, Bibi S, Chen L, Jones C, Jones E, Camara S, Shrestha S, Jin C, Gibani MM, Dobinson H, Waddington C, Darton TC, Blohmke CJ, Pollard AJ. Genetic Susceptibility to Enteric Fever in Experimentally Challenged Human Volunteers. Infect Immun. 2022 Apr 21;90(4):e0038921. doi: 10.1128/iai.00389-21. Epub 2022 Mar 7.
PubMed 35254093Darton TC, Baker S, Randall A, Dongol S, Karkey A, Voysey M, Carter MJ, Jones C, Trappl K, Pablo J, Hung C, Teng A, Shandling A, Le T, Walker C, Molina D, Andrews J, Arjyal A, Basnyat B, Pollard AJ, Blohmke CJ. Identification of Novel Serodiagnostic Signatures of Typhoid Fever Using a Salmonella Proteome Array. Front Microbiol. 2017 Sep 19;8:1794. doi: 10.3389/fmicb.2017.01794. eCollection 2017.
PubMed 28970824Darton TC, Jones C, Dongol S, Voysey M, Blohmke CJ, Shrestha R, Karkey A, Shakya M, Arjyal A, Waddington CS, Gibani M, Carter MJ, Basnyat B, Baker S, Pollard AJ. Assessment and Translation of the Antibody-in-Lymphocyte Supernatant (ALS) Assay to Improve the Diagnosis of Enteric Fever in Two Controlled Human Infection Models and an Endemic Area of Nepal. Front Microbiol. 2017 Oct 23;8:2031. doi: 10.3389/fmicb.2017.02031. eCollection 2017.
PubMed 29109704Darton TC, Jones C, Blohmke CJ, Waddington CS, Zhou L, Peters A, Haworth K, Sie R, Green CA, Jeppesen CA, Moore M, Thompson BA, John T, Kingsley RA, Yu LM, Voysey M, Hindle Z, Lockhart S, Sztein MB, Dougan G, Angus B, Levine MM, Pollard AJ. Using a Human Challenge Model of Infection to Measure Vaccine Efficacy: A Randomised, Controlled Trial Comparing the Typhoid Vaccines M01ZH09 with Placebo and Ty21a. PLoS Negl Trop Dis. 2016 Aug 17;10(8):e0004926. doi: 10.1371/journal.pntd.0004926. eCollection 2016 Aug.
PubMed 27533046
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Typhoid Disease After Vaccination: a Single Centre, Randomised, Doubleblind, Placebo Controlled Study to Evaluate M01ZH09 in a Healthy Adult Challenge Model, Using Ty21a Vaccine as a Positive Control.
- ClinicalTrials.gov ID
- NCT01405521
- Acronym / sponsor ID
- OVG 2011/02
- Conditions
- Typhoid Fever, Enteric Fever, Typhoid
- Keywords
- typhoid vaccine M01ZH09, Ty21a typhoid vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Wellcome Trust, Imperial College London, University of Maryland
- Study start
- 7 Oct 2011 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.
Detailed description
Typhoid is a serious infection killing up to 600,000 people every year; it is a frequent cause of fever and hospital admission in areas where disease is common. As the infection is restricted to humans, it should be possible to eliminate typhoid; better vaccines and ways of confirming infection are required in order for this to succeed. We propose to use a recently established human typhoid challenge model in order to evaluate a novel oral vaccine candidate and to develop new methods for diagnosing typhoid.
Although there are vaccines available to prevent typhoid, they offer little protection to populations where typhoid predominates, especially young children. Currently, the effectiveness of vaccines against typhoid cannot be predicted, as measures of protection against typhoid are unknown. As a result, implementation of vaccine programmes in disease endemic regions currently requires large and expensive trials in each new population, significantly delaying programmatic implementation.
We will use a typhoid challenge model to achieve our goal of accelerating the introduction of more effective vaccines into populations with a high burden of disease. Healthy adults will be vaccinated with either a novel oral typhoid vaccine or vaccine-placebo prior to being infected with the bacteria causing typhoid. This will allow us to measure the effectiveness of the vaccine and to identify components of the immune response important in producing protection against infection.
Current methods for confirming typhoid infection are slow and insensitive, particularly in endemic regions where the cost of laboratory equipment is prohibitive. In this project, we will also explore ways to diagnose typhoid, with the aim of developing tests that are quick, reliable and are be cost-effective in resource-poor settings. This would improve individual patient management, and allow accurate measurement of disease burden, which is vital to improve the efforts of vaccine programmes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M01ZH09 vaccine | Experimental | Biological: M10ZH09 vaccine |
| Vaccine placebo | Placebo comparator | Biological: Vaccine placebo (excipients only) |
| Ty21a vaccine | Other | Biological: Ty21aPositive control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female aged 18 - 60 years inclusive and in good health.
- Have an abdominal ultrasound scan result documented demonstrating no evidence of gallbladder pathology.
- Willing to allow their general practitioner and/or hospital consultant (if relevant) and the Health Protection Unit to be notified of participation in the study.
- Agree to refrain from blood donation in the future if diagnosed with typhoid fever.
- Be willing to have 24-hour contact with study staff during the four weeks post-challenge.
Key exclusion criteria (25 listed)
- Have previously received any typhoid vaccine, been resident in a typhoid endemic country for over 6 months, been diagnosed with probable or confirmed typhoid infection or been challenged with Salmonella Typhi or enrolled in a typhoid challenge study.
- Have any known or suspected impairment or alteration of immune function.
- History of significant cardiovascular disease.
- History of significant respiratory disease.
- History of significant endocrine disorder.
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 |
|---|---|---|
| Vaccine placebo (excipients only)single oral dose, | Biological | Vaccine placebo |
| Ty21aAlso: Vivotif3 oral doses, alternate days | Biological | Ty21a vaccine |
| M10ZH09 vaccineAlso: Typhellasingle oral dose | Biological | M01ZH09 vaccine |
Primary outcome
Diagnosis of typhoid fever
Time frame: 2 weeks after typhoid challenge
Typhoid fever defined as development of Gram negative bacteraemia after day 5 or temperature over 38C persisting for 12 hours or more. Typhoid challenge defined as ingestion of virulent S. Typhi (Quailes strain).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 30252031Gibani MM, Voysey M, Jin C, Jones C, Thomaides-Brears H, Jones E, Baker P, Morgan M, Simmons A, Gordon MA, Cerundolo V, Pitzer VE, Angus B, Levine MM, Darton TC, Pollard AJ. The Impact of Vaccination and Prior Exposure on Stool Shedding of Salmonella Typhi and Salmonella Paratyphi in 6 Controlled Human Infection Studies. Clin Infect Dis. 2019 Apr 8;68(8):1265-1273. doi: 10.1093/cid/ciy670.
- Background: PubMed 26394303Darton TC, Blohmke CJ, Giannoulatou E, Waddington CS, Jones C, Sturges P, Webster C, Drakesmith H, Pollard AJ, Armitage AE. Rapidly Escalating Hepcidin and Associated Serum Iron Starvation Are Features of the Acute Response to Typhoid Infection in Humans. PLoS Negl Trop Dis. 2015 Sep 22;9(9):e0004029. doi: 10.1371/journal.pntd.0004029. eCollection 2015 Sep.
- Background: PubMed 29387052Juel HB, Thomaides-Brears HB, Darton TC, Jones C, Jones E, Shrestha S, Sie R, Eustace A, Galal U, Kurupati P, Van TT, Thieu NTV, Baker S, Blohmke CJ, Pollard AJ. Salmonella Typhi Bactericidal Antibodies Reduce Disease Severity but Do Not Protect against Typhoid Fever in a Controlled Human Infection Model. Front Immunol. 2018 Jan 17;8:1916. doi: 10.3389/fimmu.2017.01916. eCollection 2017.
- Background: PubMed 29075261Blohmke CJ, Hill J, Darton TC, Carvalho-Burger M, Eustace A, Jones C, Schreiber F, Goodier MR, Dougan G, Nakaya HI, Pollard AJ. Induction of Cell Cycle and NK Cell Responses by Live-Attenuated Oral Vaccines against Typhoid Fever. Front Immunol. 2017 Oct 12;8:1276. doi: 10.3389/fimmu.2017.01276. eCollection 2017.
- Background: PubMed 35254093Barton A, Hill J, Bibi S, Chen L, Jones C, Jones E, Camara S, Shrestha S, Jin C, Gibani MM, Dobinson H, Waddington C, Darton TC, Blohmke CJ, Pollard AJ. Genetic Susceptibility to Enteric Fever in Experimentally Challenged Human Volunteers. Infect Immun. 2022 Apr 21;90(4):e0038921. doi: 10.1128/iai.00389-21. Epub 2022 Mar 7.
- Background: PubMed 28970824Darton TC, Baker S, Randall A, Dongol S, Karkey A, Voysey M, Carter MJ, Jones C, Trappl K, Pablo J, Hung C, Teng A, Shandling A, Le T, Walker C, Molina D, Andrews J, Arjyal A, Basnyat B, Pollard AJ, Blohmke CJ. Identification of Novel Serodiagnostic Signatures of Typhoid Fever Using a Salmonella Proteome Array. Front Microbiol. 2017 Sep 19;8:1794. doi: 10.3389/fmicb.2017.01794. eCollection 2017.
- Background: PubMed 29109704Darton TC, Jones C, Dongol S, Voysey M, Blohmke CJ, Shrestha R, Karkey A, Shakya M, Arjyal A, Waddington CS, Gibani M, Carter MJ, Basnyat B, Baker S, Pollard AJ. Assessment and Translation of the Antibody-in-Lymphocyte Supernatant (ALS) Assay to Improve the Diagnosis of Enteric Fever in Two Controlled Human Infection Models and an Endemic Area of Nepal. Front Microbiol. 2017 Oct 23;8:2031. doi: 10.3389/fmicb.2017.02031. eCollection 2017.
- Results publication: PubMed 27533046Darton TC, Jones C, Blohmke CJ, Waddington CS, Zhou L, Peters A, Haworth K, Sie R, Green CA, Jeppesen CA, Moore M, Thompson BA, John T, Kingsley RA, Yu LM, Voysey M, Hindle Z, Lockhart S, Sztein MB, Dougan G, Angus B, Levine MM, Pollard AJ. Using a Human Challenge Model of Infection to Measure Vaccine Efficacy: A Randomised, Controlled Trial Comparing the Typhoid Vaccines M01ZH09 with Placebo and Ty21a. PLoS Negl Trop Dis. 2016 Aug 17;10(8):e0004926. doi: 10.1371/journal.pntd.0004926. eCollection 2016 Aug.
- Oxford Vaccine Group homepageLink provided by the sponsor.
- Blohmke CJ, Hill J, Darton TC, Carvalho-Burger M, Eustace A, Jones C, Schreiber F, Goodier MR, Dougan G, Nakaya HI, Pollard AJ. Induction of Cell Cycle and NK Cell Responses by Live-Attenuated Oral Vaccines against Typhoid Fever.Link provided by the sponsor.
- The Impact of Vaccination and Prior Exposure on Stool Shedding of Salmonella Typhi and Salmonella Paratyphi in 6 Controlled Human Infection StudiesLink provided by the sponsor.
- Rapidly Escalating Hepcidin and Associated Serum Iron Starvation Are Features of the Acute Response to Typhoid Infection in HumansLink provided by the sponsor.
- Salmonella Typhi Bactericidal Antibodies Reduce Disease Severity but Do Not Protect against Typhoid Fever in a Controlled Human Infection ModelLink provided by the sponsor.
- Induction of Cell Cycle and NK Cell Responses by Live-Attenuated Oral Vaccines against Typhoid FeverLink provided by the sponsor.
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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.
Andrew J Pollard principal investigator
Oxford Vaccine Group, Department of Paediatrics, University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ty21a and M10ZH09 vaccine in people with Typhoid Fever and Enteric Fever, run by University of Oxford at 1 site in United Kingdom.
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 5 inclusion and 25 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnosis of typhoid fever (time frame: 2 weeks after typhoid challenge). 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 NCT01405521, which also lists 8 linked publications.
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 6 May 2023.