Typhoid FeverNCT02192008
Investigating Enteric Fever - Salmonella Typhi and Paratyphi Challenge Study
A study testing Salmonella Typhi and Salmonella Paratyphi in people with Typhoid Fever and Paratyphoid Fever, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Enteric fever, an infection characterised by diarrhoea and rash, is most often caused by a bacteria called Salmonella enterica. After ingesting contaminated food or drink, the Salmonellae travel first to the gut, then the bloodstream, from where they can infect other parts of the body. 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, Paratyphoid Fever
- What is being tested?
- Salmonella Typhi and Salmonella Paratyphi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to 26 May 2022
- Phase
- Interventional
- 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
- In good health as determined by medical history, physical examination and clinical judgment of the investigators.
- Agree (in the Investigator's opinion) to comply with all study requirements, including capacity to adhere to good personal hygiene and infection control precautions.
- Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study.
- Agree to allow Public Health England to be informed of their participation in the study .
- Agree to give his or her close household contacts written information informing them of the participants' involvement in the study and offering them voluntary screening for S. Typhi or S. Paratyphi carriage.
- Agree to have 24-hour contact with study staff during the four weeks post challenge and are able to ensure that they are contactable by mobile phone for the duration of the challenge period until antibiotic completion.
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- Have internet access to allow completion of the e-diary and real-time safety monitoring.
- Agree to avoid antipyretic/anti-inflammatory treatment until advised by a study doctor or until at least 14 days after challenge.
- Willing to undergo endoscopy and biopsy.
Who cannot join
- History of significant organ/system disease that could interfere with study conduct or completion.
- Have any known or suspected impairment of immune function, alteration of immune function, or prior immune exposure that may alter immune function.
- Moderate or severe depression or anxiety as classified by the Hospital Anxiety and Depression Score at screening or challenge that is deemed clinically significant by the study investigators.
- Weight 50kg or less.
- Presence of implants or prosthesis.
- Have previously received any typhoid vaccine
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- Any contraindication to elective upper GI endoscopy.
- More than one non-study related upper GI endoscopy within the last year.
- Anyone taking long-term medication that may affect symptom reporting or interpretation of the study results.
- Contra-indication to taking ciprofloxacin, azithromycin, trimethoprim/ sulfamethoxazole and/or beta lactam antibiotics.
- Female participants who are pregnant or lactating.
- Female participants who are unwilling to ensure that they or their partner use effective contraception one month prior to challenge and continue to do so until two negative stool samples, a minimum of three weeks after completion of antibiotic treatment, have been obtained.
- Full-time, part-time or voluntary occupations involving clinical or social work with direct contact with young children (defined as those attending pre-school groups or nursery or aged under 2 years); clinical or social work with direct contact with highly susceptible patients or persons in whom typhoid or paratyphoid infection would have particularly serious consequences e.g. the elderly or infirm.
- Full time, part time or voluntary occupations involving commercial food handling.
- Close household contact with young children (defined as those attending pre-school groups, nursery or those aged less than 2 years), individual(s) who is (are) immunocompromised, scheduled elective surgery or other procedures requiring general anaesthesia during the study period.
- Participants who have participated in another research study involving an investigational product that might affect risk of typhoid or paratyphoid infection or compromise the integrity of the study within the 30 days prior to enrolment .
- Detection of any significantly abnormal results from screening investigations.
- Inability to comply with any of the study requirements.
- Any other social, psychological or health issues which, in the opinion of the study investigator, may put the participants or their contacts at risk because of participation in the study, adversely affect the interpretation of the primary endpoint data, or impair the participant's ability to participate in the study.
- Having been resident in an enteric fever endemic country for six months or more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Mechanisms and Determinants of Systemic and Mucosal Immunity to Salmonella Typhi and Salmonella Paratyphi A in naïve and Previously Exposed Individuals - A Challenge and Rechallenge Study
Enteric fever, an infection characterised by diarrhoea and rash, is most often caused by a bacteria called Salmonella enterica. After ingesting contaminated food or drink, the Salmonellae travel first to the gut, then the bloodstream, from where they can infect other parts of the body. Antibiotics are used to kill the bacteria, but with increasing rates of antibiotic resistance, this treatment is becoming less effective.
Two Salmonella variants, Typhi and Paratyphi, cause over 30 million cases of enteric fever and more than 200,000 deaths per year, mostly in developing countries. While improved hygiene and sanitation should eventually eliminate enteric fever, reduction of the disease burden in the medium term is achievable through effective vaccination.
Read more
Vaccines likely to be available for mass vaccination are effective only against those Salmonella strains that bear the Vi polysaccharide capsule protein. Strains that do not have these capsule proteins, or have no capsule, will not be affected by vaccination and could 'fill' the space vacated by the capsulated strains. Indeed, enteric fever caused by S. Paratyphi A which does not carry the Vi protein, has risen during the past decade and accounts for more than half of all cases in some areas. Thus it is important that effective vaccines are available to protect against infection by both capsulated and noncapsulated Salmonella enterica. To develop such vaccines, we need a complete understanding of the human immune response to both types, including the contribution of immunity in the gut and the bloodstream, immune response to bacterial surface proteins, and the role of antibodies. How much cross-protection there is between the types of typhoidal Salmonellae after natural infection or vaccination is not known, but this is critical to vaccine development.
This project aims to fill in the knowledge gaps highlighted, by fully characterising the infection process and immune response in enteric fever.
Read the detailed description
There are two main groups in this study. Firstly a group of 40 to 60 volunteers recruited from the community and not previously exposed to typhoidal Salmonella (part A); secondly a group of 20 to 60 volunteers from participants of previous challenge studies conducted by the Oxford Vaccine Group (part B).
Participants in part A and B will be randomly allocated one-to-one to have either S. Typhi or S. Paratyphi. The dose of bacteria has been determined by previous challenge studies to give an attack rate of 60 to 75% in individuals naive to typhoidal Salmonella. The bacteria is then ingested as a drink with a bicarbonate buffer ('the challenge').
In addition to these two groups, a preliminary study involving 3 to 10 participants to act as 'negative controls' will be performed. They will ingest the bicarbonate drink but not be given S. Typhi or S. Paratyphi. This group is not randomised with part A or B, and is unblinded i.e. the participant will be aware that they are not drinking typhoidal Salmonella. The participants will have all the same procedures and investigations as those in part A and B, including endoscopy with biopsies, daily visits during the two week intensive phase, and a course of antibiotics.
Prior to challenge, participants (from parts A, B and negative control group) will undergo endoscopy and tissue biopsies of the gut lining. This procedure will be repeated after the intensive phase and completion of a two week course of antibiotics.
After challenge, participants will be reviewed daily for at least 14 days by study investigators. Samples of blood, stool, saliva and urine will be collected. Participants diagnosed with enteric fever will be treated immediately with antibiotics and samples will be taken as per the protocol. The participants who do not meet criteria for enteric fever will be treated with antibiotics on Day 14.
Enteric fever is diagnosed if any of the following apply:
- A positive blood culture for S. Typhi or Paratyphi from 72 hours post-challenge,
- a positive blood culture for S. Typhi or Paratyphi within 72 hours post-challenge, with one or more signs/symptoms of enteric fever,
- persistent positive blood cultures (two or more blood cultures taken at least 4 hours apart) for S. Typhi or Paratyphi within 72 hours postchallenge, or
- oral temperature ≥ to 38°C persisting for 12 hours.
A proportion of participants from Part A and B will be offered the optional procedures of enteric string tests (also called Enterotest) and/or Wireless Video Capsule Endoscopies (WCE). Participants consenting to these procedures will be selected sequentially until the quota has been filled for each group.
- Conditions
- Typhoid Fever, Paratyphoid Fever
- Being tested
- Salmonella Typhi, Salmonella Paratyphi
- Keywords
- Challenge, Re-challenge, Controlled Infection, Enteric fever
- Medical subject headings
- Typhoid Fever, Paratyphoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmonella TyphiBiological
Salmonella ParatyphiBiological
| Study group | Role | What they receive |
|---|---|---|
| Part A | Active comparator | Cohort naive to typhoidal Salmonella challenged with either S. Typhi or S. Paratyphi Receives: Biological: Salmonella Typhi; Biological: Salmonella Paratyphi |
| Part B | Active comparator | Cohort previously challenged with S. Typhi or Paratyphi re-challenged with either S. Typhi or S. Paratyphi. Receives: Biological: Salmonella Typhi; Biological: Salmonella Paratyphi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the attack rate after challenge with S. Typhi or S. Paratyphi A in naïve and previously challenged individuals.
Based on clinical and/or microbiological proven enteric fever infection.
Measured: 12 months
Secondary outcomes (5)
To describe the human clinical response to S. Typhi or S. Paratyphi A in antigen-naïve and previously challenged individuals.
The clinical response after challenge or re-challenge using participant symptom profiles, laboratory parameters (including inflammatory markers, blood count, liver function tests and microbiological culture results) will be used.
Measured: 12 months
To describe the characteristics of bacterial dynamics after challenge in naïve and previously exposed individuals, including onset and duration of bacteraemia, bacterial burden at diagnosis, bacterial burden in enteric fluid, and stool shedding.
Microbiological culture (qualitative and quantitative) and polymerase chain reaction to detect and characterise S. Typhi or S. Paratyphi A in blood, stool and enteric fluid.
Measured: 12 months
To determine the gut luminal mucosal response to challenge with S. Typhi and S. Paratyphi.
Mucosal inflammation as determined by (1) macroscopic appearance of mucosal inflammation as seen on endoscopy and wireless video capsule endoscopy (judged by experienced endoscopists), (2) inflammatory markers such as calprotectin and lactoferrin performed on stool and duodenal secretions.
Measured: 12 months
To describe the human immune response to challenge or re-challenge, including the innate, humoral, cell-mediated and mucosal responses.
Assessed by immunological laboratory assays including quantitative and functional assays of the humoral (e.g. ELISA, enzyme-linked immunospot, serum bactericidal assay and opsonophagocytosis assay), mucosal (secretory immunoglobulin A measurement), and cell-mediated (multi-chromatic flow cytometry, mass cytometry, cytokine measurement) immune response.
Measured: 12 months
Determine host genetic features influencing: • clinical manifestations of challenge with typhi/paratyphi • alteration of those responses through epigenetic changes • and control of gene and protein expression.
Assessed by laboratory and high-throughput assays including:
- measurement of baseline genetic susceptibility factors by whole genome sequencing
- the transcriptional response to challenge and infection
- detection of translated proteins by mass spectrometry (CyTOF).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startDec 2014
- Primary completion22 Sep 2018
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Andrew Pollard, FRCPCH, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192008
- Sponsor's protocol ID
- OVG 2014/01
- Status last verified
- Jan 2021
- First submitted
- 1 Jul 2014
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gibani MM, Jin C, Shrestha S, Moore M, Norman L, Voysey M, Jones E, Blackwell L, Thomaides-Brears H, Hill J, Blohmke CJ, Dobinson HC, Baker P, Jones C, Campbell D, Mujadidi YF, Plested E, Preciado-Llanes L, Napolitani G, Simmons A, Gordon MA, Angus B, Darton TC, Cerundulo V, Pollard AJ. Homologous and heterologous re-challenge with Salmonella Typhi and Salmonella Paratyphi A in a randomised controlled human infection model. PLoS Negl Trop Dis. 2020 Oct 20;14(10):e0008783. doi: 10.1371/journal.pntd.0008783. eCollection 2020 Oct.
PubMed 33079959Jin C, Gibani MM, Pennington SH, Liu X, Ardrey A, Aljayyoussi G, Moore M, Angus B, Parry CM, Biagini GA, Feasey NA, Pollard AJ. Treatment responses to Azithromycin and Ciprofloxacin in uncomplicated Salmonella Typhi infection: A comparison of Clinical and Microbiological Data from a Controlled Human Infection Model. PLoS Negl Trop Dis. 2019 Dec 26;13(12):e0007955. doi: 10.1371/journal.pntd.0007955. eCollection 2019 Dec.
PubMed 31877141
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Mechanisms and Determinants of Systemic and Mucosal Immunity to Salmonella Typhi and Salmonella Paratyphi A in naïve and Previously Exposed Individuals - A Challenge and Rechallenge Study
- ClinicalTrials.gov ID
- NCT02192008
- Acronym / sponsor ID
- OVG 2014/01
- Conditions
- Typhoid Fever, Paratyphoid Fever
- Keywords
- Challenge, Re-challenge, Controlled Infection, Enteric fever
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Liverpool, Brigham and Women's Hospital
- Study start
- Dec 2014
- Primary completion
- 22 Sep 2018 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 16 Jul 2014 (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.
Enteric fever, an infection characterised by diarrhoea and rash, is most often caused by a bacteria called Salmonella enterica. After ingesting contaminated food or drink, the Salmonellae travel first to the gut, then the bloodstream, from where they can infect other parts of the body. Antibiotics are used to kill the bacteria, but with increasing rates of antibiotic resistance, this treatment is becoming less effective.
Two Salmonella variants, Typhi and Paratyphi, cause over 30 million cases of enteric fever and more than 200,000 deaths per year, mostly in developing countries. While improved hygiene and sanitation should eventually eliminate enteric fever, reduction of the disease burden in the medium term is achievable through effective vaccination.
Vaccines likely to be available for mass vaccination are effective only against those Salmonella strains that bear the Vi polysaccharide capsule protein. Strains that do not have these capsule proteins, or have no capsule, will not be affected by vaccination and could 'fill' the space vacated by the capsulated strains. Indeed, enteric fever caused by S. Paratyphi A which does not carry the Vi protein, has risen during the past decade and accounts for more than half of all cases in some areas. Thus it is important that effective vaccines are available to protect against infection by both capsulated and noncapsulated Salmonella enterica. To develop such vaccines, we need a complete understanding of the human immune response to both types, including the contribution of immunity in the gut and the bloodstream, immune response to bacterial surface proteins, and the role of antibodies. How much cross-protection there is between the types of typhoidal Salmonellae after natural infection or vaccination is not known, but this is critical to vaccine development.
This project aims to fill in the knowledge gaps highlighted, by fully characterising the infection process and immune response in enteric fever.
Detailed description
There are two main groups in this study. Firstly a group of 40 to 60 volunteers recruited from the community and not previously exposed to typhoidal Salmonella (part A); secondly a group of 20 to 60 volunteers from participants of previous challenge studies conducted by the Oxford Vaccine Group (part B).
Participants in part A and B will be randomly allocated one-to-one to have either S. Typhi or S. Paratyphi. The dose of bacteria has been determined by previous challenge studies to give an attack rate of 60 to 75% in individuals naive to typhoidal Salmonella. The bacteria is then ingested as a drink with a bicarbonate buffer ('the challenge').
In addition to these two groups, a preliminary study involving 3 to 10 participants to act as 'negative controls' will be performed. They will ingest the bicarbonate drink but not be given S. Typhi or S. Paratyphi. This group is not randomised with part A or B, and is unblinded i.e. the participant will be aware that they are not drinking typhoidal Salmonella. The participants will have all the same procedures and investigations as those in part A and B, including endoscopy with biopsies, daily visits during the two week intensive phase, and a course of antibiotics.
Prior to challenge, participants (from parts A, B and negative control group) will undergo endoscopy and tissue biopsies of the gut lining. This procedure will be repeated after the intensive phase and completion of a two week course of antibiotics.
After challenge, participants will be reviewed daily for at least 14 days by study investigators. Samples of blood, stool, saliva and urine will be collected. Participants diagnosed with enteric fever will be treated immediately with antibiotics and samples will be taken as per the protocol. The participants who do not meet criteria for enteric fever will be treated with antibiotics on Day 14.
Enteric fever is diagnosed if any of the following apply:
- A positive blood culture for S. Typhi or Paratyphi from 72 hours post-challenge,
- a positive blood culture for S. Typhi or Paratyphi within 72 hours post-challenge, with one or more signs/symptoms of enteric fever,
- persistent positive blood cultures (two or more blood cultures taken at least 4 hours apart) for S. Typhi or Paratyphi within 72 hours postchallenge, or
- oral temperature ≥ to 38°C persisting for 12 hours.
A proportion of participants from Part A and B will be offered the optional procedures of enteric string tests (also called Enterotest) and/or Wireless Video Capsule Endoscopies (WCE). Participants consenting to these procedures will be selected sequentially until the quota has been filled for each group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Active comparator | Biological: Salmonella Typhi, Biological: Salmonella ParatyphiCohort naive to typhoidal Salmonella challenged with either S. Typhi or S. Paratyphi |
| Part B | Active comparator | Biological: Salmonella Typhi, Biological: Salmonella ParatyphiCohort previously challenged with S. Typhi or Paratyphi re-challenged with either S. Typhi or S. Paratyphi. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- In good health as determined by medical history, physical examination and clinical judgment of the investigators.
- Agree (in the Investigator's opinion) to comply with all study requirements, including capacity to adhere to good personal hygiene and infection control precautions.
- Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study.
- Agree to allow Public Health England to be informed of their participation in the study .
- Agree to give his or her close household contacts written information informing them of the participants' involvement in the study and offering them voluntary screening for S. Typhi or S. Paratyphi carriage.
Key exclusion criteria (20 listed)
- History of significant organ/system disease that could interfere with study conduct or completion.
- Have any known or suspected impairment of immune function, alteration of immune function, or prior immune exposure that may alter immune function.
- Moderate or severe depression or anxiety as classified by the Hospital Anxiety and Depression Score at screening or challenge that is deemed clinically significant by the study investigators.
- Weight 50kg or less.
- Presence of implants or prosthesis.
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 |
|---|---|---|
| Salmonella Typhi | Biological | Part A, Part B |
| Salmonella Paratyphi | Biological | Part A, Part B |
Primary outcome
Measure the attack rate after challenge with S. Typhi or S. Paratyphi A in naïve and previously challenged individuals.
Time frame: 12 months
Based on clinical and/or microbiological proven enteric fever infection.
5 secondary outcomes
To describe the human clinical response to S. Typhi or S. Paratyphi A in antigen-naïve and previously challenged individuals.
Time frame: 12 months
To describe the characteristics of bacterial dynamics after challenge in naïve and previously exposed individuals, including onset and duration of bacteraemia, bacterial burden at diagnosis, bacterial burden in enteric fluid, and stool shedding.
Time frame: 12 months
To determine the gut luminal mucosal response to challenge with S. Typhi and S. Paratyphi.
Time frame: 12 months
To describe the human immune response to challenge or re-challenge, including the innate, humoral, cell-mediated and mucosal responses.
Time frame: 12 months
Determine host genetic features influencing: • clinical manifestations of challenge with typhi/paratyphi • alteration of those responses through epigenetic changes • and control of gene and protein expression.
Time frame: 12 months
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 2 Jun 2022.
- Background: PubMed 33079959Gibani MM, Jin C, Shrestha S, Moore M, Norman L, Voysey M, Jones E, Blackwell L, Thomaides-Brears H, Hill J, Blohmke CJ, Dobinson HC, Baker P, Jones C, Campbell D, Mujadidi YF, Plested E, Preciado-Llanes L, Napolitani G, Simmons A, Gordon MA, Angus B, Darton TC, Cerundulo V, Pollard AJ. Homologous and heterologous re-challenge with Salmonella Typhi and Salmonella Paratyphi A in a randomised controlled human infection model. PLoS Negl Trop Dis. 2020 Oct 20;14(10):e0008783. doi: 10.1371/journal.pntd.0008783. eCollection 2020 Oct.
- Derived from this study: PubMed 31877141Jin C, Gibani MM, Pennington SH, Liu X, Ardrey A, Aljayyoussi G, Moore M, Angus B, Parry CM, Biagini GA, Feasey NA, Pollard AJ. Treatment responses to Azithromycin and Ciprofloxacin in uncomplicated Salmonella Typhi infection: A comparison of Clinical and Microbiological Data from a Controlled Human Infection Model. PLoS Negl Trop Dis. 2019 Dec 26;13(12):e0007955. doi: 10.1371/journal.pntd.0007955. eCollection 2019 Dec.
- Homologous and heterologous re-challenge with Salmonella Typhi and Salmonella Paratyphi A in a randomised controlled human infection modelLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink 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 Pollard, FRCPCH, PhD principal investigator
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 study testing Salmonella Typhi and Salmonella Paratyphi in people with Typhoid Fever and Paratyphoid 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 9 inclusion and 20 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 2 Jun 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Measure the attack rate after challenge with S. Typhi or S. Paratyphi A in naïve and previously challenged individuals. (time frame: 12 months). 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 NCT02192008, which also lists 2 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 2 Jun 2022.