Enteric Fever Caused by Salmonella Enterica Serovar Paratyphi ANCT02100397
Understanding Paratyphoid Infection
A study testing Salmonella enterica serovar Paratyphi A (strain NVGH308) in people with Enteric Fever Caused by Salmonella Enterica Serovar Paratyphi A, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Enteric fever is responsible for over 20 million illnesses and 200,000 deaths each year. S. Paratyphi A accounts for a substantial and increasing proportion of these cases, as high as 90% in some regions of Asia. There are currently no vaccines directed against S. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Enteric Fever Caused by Salmonella Enterica Serovar Paratyphi A
- What is being tested?
- Salmonella enterica serovar Paratyphi A (strain NVGH308)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to 9 Mar 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
- Agree to give informed consent for participation in the study.
- Aged between 18 and 60 years inclusive at time of challenge.
- 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.
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- 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. Paratyphi carriage.
- If diagnosed with paratyphoid infection: agree to refrain from future blood donation to the National Blood Service.
- 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.
- Have internet access to allow completion of the eDiary and real-time safety monitoring.
- Agree to avoid antipyretic/anti-inflammatory treatment until advised by a study doctor or until 14 days after challenge.
- Agree to provide their National Insurance/Passport number for the purposes of TOPS registration and for payment of reimbursement expenses.
Who cannot join
- History of significant organ/system disease that could interfere with trial conduct or completion. Including, for example, but not restricted to:
- Cardiovascular disease
- Respiratory disease
- Hematological disease
- Endocrine disorders
- Renal or bladder disease, including history of renal calculi
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- Biliary tract disease, including biliary colic, asymptomatic gallstones or previous cholecystectomy
- Gastro-intestinal disease including requirement for antacids, H2-receptor antagonists, proton pump inhibitors or laxatives
- Neurological disease
- Metabolic disease
- Autoimmune disease
- Psychiatric illness requiring hospitalization or known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week)
- Infectious disease.
- Have any known or suspected impairment of immune function, alteration of immune function, or prior immune exposure that may alter immune function to paratyphoid resulting from, for example:
- Congenital or acquired immunodeficiency, including IgA deficiency
- Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
- Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy
- Receipt of immunoglobulin or any blood product transfusion within 3 months of study start.
- History of cancer (except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ).
- 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 less than 50kg.
- Presence of implants or prosthesis.
- Anyone taking long-term medication (e.g. analgesia, anti-inflammatories or antibiotics) that may affect symptom reporting or interpretation of the study results.
- Contra-indication to ciprofloxacin, beta-lactam antibiotics and trimethoprim/sulfamethoxazole therapy.
- Female participants who are pregnant, lactating or 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 2 weeks after completion of antibiotic treatment, has 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), or
- Clinical or social work with direct contact with highly susceptible patients or persons in whom paratyphoid infection would have particularly serious consequences (unless willing to avoid work until demonstrated not to be infected with S. Paratyphi in accordance with guidance from Public Health England and willing to allow us to inform their employer).
- Full time, part time or voluntary occupations involving:
- o Commercial food handling (involving preparing or serving unwrapped foods not subjected to further heating)
- 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 paratyphoid infection or compromise the integrity of the study within the 30 days prior to enrolment (e.g. significant volumes of blood already taken in previous study) .
- Detection of any abnormal results from screening investigations (at the clinical discretion of the study investigators).
- Inability to comply with any of the study requirements (at the discretion of the study investigators and the participants General Practitioner).
- 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,
- Impair the participant's ability to participate in the study.
- Having previously received any live oral typhoid vaccine (those who have received Vi polysaccharide vaccine will not be excluded).
- Having been resident in an enteric fever endemic country 6 months or more.
- Have previously been diagnosed with laboratory-confirmed typhoid or paratyphoid infection or been given a diagnosis compatible with enteric fever.
- Have participated in previous typhoid challenge studies (with ingestion of challenge agent).
- Currently working for the Oxford Vaccine Group.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: Development of a Human Model of Salmonella Enterica Serovar Paratyphi A Challenge in Healthy Adult Volunteers
Enteric fever is responsible for over 20 million illnesses and 200,000 deaths each year. S. Paratyphi A accounts for a substantial and increasing proportion of these cases, as high as 90% in some regions of Asia. There are currently no vaccines directed against S. Paratyphi A, although there some candidates in preclinical and phase 1 trials. This study is funded by the European Vaccine Initiative and the Bill and Melinda Gates Foundation. Paratyphoid is a human-restricted infection, for which there are currently no small animal models available. In order to further our understanding of the host-pathogen interactions, this study will develop a novel human challenge model in which to investigate this infection, using a recent successful typhoid challenge model as its template.
Healthy subjects to ingest a dose of Salmonella enterica serovar Paratyphi A, strain NVGH308, after drinking a bicarbonate buffer. Intensive follow up over 14 days will establish whether each participant meets clearly defined criteria for diagnosis of paratyphoid infection. Statistical analysis will be performed on this outcome will determine if it consistently gives an attack rate of 60 to 75%. If this is not reached with the first cohort of 20 participants, the dose will be escalated and the process repeated. A maximum of 80 participants will be enrolled. Total follow up will be over the course of one year. Descriptive clinical and laboratory data collected from participant observations, samples of blood, faeces, urine and saliva will allow insights into the disease and the host response. These insights will forward our knowledge of paratyphoid disease and may help discover or develop diagnostic methods.
Read more
This study is funded by the European Vaccine Initiative and the Bill and Melinda Gates Foundation. Paratyphoid is a human-restricted infection, for which there are currently no small animal models available. In order to further our understanding of the host-pathogen interactions, this study will develop a novel human challenge model in which to investigate this infection, using a recent successful typhoid challenge model as its template.
Healthy subjects will ingest a dose of Salmonella enterica serovar Paratyphi A, strain NVGH308, after drinking a bicarbonate buffer. Intensive follow up over 14 days will establish whether each participant meets clearly defined criteria for diagnosis of paratyphoid infection. Statistical analysis will be performed on this outcome will determine if it consistently gives an attack rate of 60 to 75%. If this is not reached with the first cohort of 20 participants, the dose will be escalated and the process repeated. A maximum of 80 participants will be enrolled. Total follow up will be over the course of one year. Descriptive clinical and laboratory data collected from participant observations, samples of blood, faeces, urine and saliva will allow insights into the disease and the host response. These insights will forward our knowledge of paratyphoid disease and may help discover or develop diagnostic methods. Anticipating the development of a successful live challenge model through this study, there will be the possibility of evaluating novel paratyphoid vaccines that are currently in early clinical phase testing. This serves an important function because field trials in endemic areas are expensive and time consuming. Speeding up this process using our model will be of great benefit to endemic areas.
- Being tested
- Salmonella enterica serovar Paratyphi A (strain NVGH308)
- Keywords
- Enteric fever, Paratyphoid, Salmonella Paratyphi, Challenge study, Human model of infection
- 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 enterica serovar Paratyphi A (strain NVGH308)Biological
Ingestion of 1-5x10³ to 1-5x10⁵ colony forming units (CFU) of the challenge strain after bicarbonate buffer solution.
| Study group | Role | What they receive |
|---|---|---|
| Dose | Experimental | A dose of S.paratyphi will be given to up to 20 participants to determine the attack rate. Receives: Biological: Salmonella enterica serovar Paratyphi A (strain NVGH308) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical or microbiologically proven paratyphoid infection.
Clinical or microbiologically proven paratyphoid infection following oral challenge with Salmonella Paratyphi A, strain NVGH308, delivered with sodium bicarbonate solution.
Measured: Up to 14 days after challenge dose administered
Secondary outcomes (7)
Human physiological response
Description of the clinical course after challenge using, for example, participant symptom profiles, temperature measurements and other recorded clinical and laboratory observations. The outcomes will be measured in terms of number of participants and/or proportion of participants developing a certain clinical observation. For certain observations mean time from dosing to the development of that observation (e.g. development of a temperature >38C).
Measured: Clinical signs and solicited symptoms measured in the 21 day period after challenge; laboratory and unsolicited symptoms followed up over the course of one year
Evaluation of the sensitivity of paratyphoid diagnostic criteria
Determination of challenge dose/kg (dose/surface area) actually ingested by those developing and those not developing paratyphoid infection at each dose level.
Analysis of the attack rate using alternative criteria including, for example, passive field surveillance definitions, alternative temperature thresholds and adjunctive microbiological and laboratory diagnostic assays.
Measured: Up to one year after challenge
Describe the characteristics of bacterial dynamics post challenge
Microbiological assays to detect and characterise Salmonella Paratyphi after challenge in blood, stool and urine.
Measured: Up to one year after challenge
Describe the human immune response to S. Paratyphi
Immunological laboratory assays to measure innate, humoral, cell-mediated and mucosal responses to challenge.
Measured: Up to one year after challenge
Genetic features
Laboratory and high-throughput assays to measure genetic factors affecting susceptibility, gene expression and protein translation.
Measured: Up to one year after challenge
Discovery/ development of diagnostic methods
Exploratory analysis of blood, faeces, saliva and urine samples using experimental assays and diagnostics. For example, identification of molecules in urine associated with disease using mass spectrometry.
Measured: Up to one year after challenge
Exploration of participants' motivation for involvement in challenge studies
Participant responses using questionnaires during the course of the study.
Measured: Up to one year after challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2016
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Enteric Fever Caused by Salmonella Enterica Serovar Paratyphi AStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Pollard, MBBS, Principal investigator, Oxford Vaccine Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100397
- Sponsor's protocol ID
- OVG 2013/07
- Status last verified
- Mar 2022
- First submitted
- 12 Nov 2013
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Napolitani G, Kurupati P, Teng KWW, Gibani MM, Rei M, Aulicino A, Preciado-Llanes L, Wong MT, Becht E, Howson L, de Haas P, Salio M, Blohmke CJ, Olsen LR, Pinto DMS, Scifo L, Jones C, Dobinson H, Campbell D, Juel HB, Thomaides-Brears H, Pickard D, Bumann D, Baker S, Dougan G, Simmons A, Gordon MA, Newell EW, Pollard AJ, Cerundolo V. Clonal analysis of Salmonella-specific effector T cells reveals serovar-specific and cross-reactive T cell responses. Nat Immunol. 2018 Jul;19(7):742-754. doi: 10.1038/s41590-018-0133-z. Epub 2018 Jun 20.
PubMed 29925993Dobinson HC, Gibani MM, Jones C, Thomaides-Brears HB, Voysey M, Darton TC, Waddington CS, Campbell D, Milligan I, Zhou L, Shrestha S, Kerridge SA, Peters A, Stevens Z, Podda A, Martin LB, D'Alessio F, Thanh DP, Basnyat B, Baker S, Angus B, Levine MM, Blohmke CJ, Pollard AJ. Evaluation of the Clinical and Microbiological Response to Salmonella Paratyphi A Infection in the First Paratyphoid Human Challenge Model. Clin Infect Dis. 2017 Apr 15;64(8):1066-1073. doi: 10.1093/cid/cix042.
PubMed 28158395Howson LJ, Napolitani G, Shepherd D, Ghadbane H, Kurupati P, Preciado-Llanes L, Rei M, Dobinson HC, Gibani MM, Teng KWW, Newell EW, Veerapen N, Besra GS, Pollard AJ, Cerundolo V. MAIT cell clonal expansion and TCR repertoire shaping in human volunteers challenged with Salmonella Paratyphi A. Nat Commun. 2018 Jan 17;9(1):253. doi: 10.1038/s41467-017-02540-x.
PubMed 29343684McCullagh D, Dobinson HC, Darton T, Campbell D, Jones C, Snape M, Stevens Z, Plested E, Voysey M, Kerridge S, Martin LB, Angus B, Pollard AJ. Understanding paratyphoid infection: study protocol for the development of a human model of Salmonella enterica serovar Paratyphi A challenge in healthy adult volunteers. BMJ Open. 2015 Jun 16;5(6):e007481. doi: 10.1136/bmjopen-2014-007481.
PubMed 26082464
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Human Model of Salmonella Enterica Serovar Paratyphi A Challenge in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02100397
- Acronym / sponsor ID
- OVG 2013/07
- Keywords
- Enteric fever, Paratyphoid, Salmonella Paratyphi, Challenge study, Human model of infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 31 Mar 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 is responsible for over 20 million illnesses and 200,000 deaths each year. S. Paratyphi A accounts for a substantial and increasing proportion of these cases, as high as 90% in some regions of Asia. There are currently no vaccines directed against S. Paratyphi A, although there some candidates in preclinical and phase 1 trials. This study is funded by the European Vaccine Initiative and the Bill and Melinda Gates Foundation. Paratyphoid is a human-restricted infection, for which there are currently no small animal models available. In order to further our understanding of the host-pathogen interactions, this study will develop a novel human challenge model in which to investigate this infection, using a recent successful typhoid challenge model as its template.
Healthy subjects to ingest a dose of Salmonella enterica serovar Paratyphi A, strain NVGH308, after drinking a bicarbonate buffer. Intensive follow up over 14 days will establish whether each participant meets clearly defined criteria for diagnosis of paratyphoid infection. Statistical analysis will be performed on this outcome will determine if it consistently gives an attack rate of 60 to 75%. If this is not reached with the first cohort of 20 participants, the dose will be escalated and the process repeated. A maximum of 80 participants will be enrolled. Total follow up will be over the course of one year. Descriptive clinical and laboratory data collected from participant observations, samples of blood, faeces, urine and saliva will allow insights into the disease and the host response. These insights will forward our knowledge of paratyphoid disease and may help discover or develop diagnostic methods.
This study is funded by the European Vaccine Initiative and the Bill and Melinda Gates Foundation. Paratyphoid is a human-restricted infection, for which there are currently no small animal models available. In order to further our understanding of the host-pathogen interactions, this study will develop a novel human challenge model in which to investigate this infection, using a recent successful typhoid challenge model as its template.
Healthy subjects will ingest a dose of Salmonella enterica serovar Paratyphi A, strain NVGH308, after drinking a bicarbonate buffer. Intensive follow up over 14 days will establish whether each participant meets clearly defined criteria for diagnosis of paratyphoid infection. Statistical analysis will be performed on this outcome will determine if it consistently gives an attack rate of 60 to 75%. If this is not reached with the first cohort of 20 participants, the dose will be escalated and the process repeated. A maximum of 80 participants will be enrolled. Total follow up will be over the course of one year. Descriptive clinical and laboratory data collected from participant observations, samples of blood, faeces, urine and saliva will allow insights into the disease and the host response. These insights will forward our knowledge of paratyphoid disease and may help discover or develop diagnostic methods. Anticipating the development of a successful live challenge model through this study, there will be the possibility of evaluating novel paratyphoid vaccines that are currently in early clinical phase testing. This serves an important function because field trials in endemic areas are expensive and time consuming. Speeding up this process using our model will be of great benefit to endemic areas.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose | Experimental | Biological: Salmonella enterica serovar Paratyphi A (strain NVGH308)A dose of S.paratyphi will be given to up to 20 participants to determine the attack rate. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Agree to give informed consent for participation in the study.
- Aged between 18 and 60 years inclusive at time of challenge.
- 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.
Key exclusion criteria (46 listed)
- History of significant organ/system disease that could interfere with trial conduct or completion. Including, for example, but not restricted to:
- Have any known or suspected impairment of immune function, alteration of immune function, or prior immune exposure that may alter immune function to paratyphoid resulting from, for example:
- 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 less than 50kg.
- 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 enterica serovar Paratyphi A (strain NVGH308)Ingestion of 1-5x10³ to 1-5x10⁵ colony forming units (CFU) of the challenge strain after bicarbonate buffer solution. | Biological | Dose |
Primary outcome
Clinical or microbiologically proven paratyphoid infection.
Time frame: Up to 14 days after challenge dose administered
Clinical or microbiologically proven paratyphoid infection following oral challenge with Salmonella Paratyphi A, strain NVGH308, delivered with sodium bicarbonate solution.
7 secondary outcomes
Human physiological response
Time frame: Clinical signs and solicited symptoms measured in the 21 day period after challenge; laboratory and unsolicited symptoms followed up over the course of one year
Evaluation of the sensitivity of paratyphoid diagnostic criteria
Time frame: Up to one year after challenge
Describe the characteristics of bacterial dynamics post challenge
Time frame: Up to one year after challenge
Describe the human immune response to S. Paratyphi
Time frame: Up to one year after challenge
Genetic features
Time frame: Up to one year after challenge
Discovery/ development of diagnostic methods
Time frame: Up to one year after challenge
Exploration of participants' motivation for involvement in challenge studies
Time frame: Up to one year after challenge
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 14 Mar 2022.
- Background: PubMed 29925993Napolitani G, Kurupati P, Teng KWW, Gibani MM, Rei M, Aulicino A, Preciado-Llanes L, Wong MT, Becht E, Howson L, de Haas P, Salio M, Blohmke CJ, Olsen LR, Pinto DMS, Scifo L, Jones C, Dobinson H, Campbell D, Juel HB, Thomaides-Brears H, Pickard D, Bumann D, Baker S, Dougan G, Simmons A, Gordon MA, Newell EW, Pollard AJ, Cerundolo V. Clonal analysis of Salmonella-specific effector T cells reveals serovar-specific and cross-reactive T cell responses. Nat Immunol. 2018 Jul;19(7):742-754. doi: 10.1038/s41590-018-0133-z. Epub 2018 Jun 20.
- Results publication: PubMed 28158395Dobinson HC, Gibani MM, Jones C, Thomaides-Brears HB, Voysey M, Darton TC, Waddington CS, Campbell D, Milligan I, Zhou L, Shrestha S, Kerridge SA, Peters A, Stevens Z, Podda A, Martin LB, D'Alessio F, Thanh DP, Basnyat B, Baker S, Angus B, Levine MM, Blohmke CJ, Pollard AJ. Evaluation of the Clinical and Microbiological Response to Salmonella Paratyphi A Infection in the First Paratyphoid Human Challenge Model. Clin Infect Dis. 2017 Apr 15;64(8):1066-1073. doi: 10.1093/cid/cix042.
- Results publication: PubMed 29343684Howson LJ, Napolitani G, Shepherd D, Ghadbane H, Kurupati P, Preciado-Llanes L, Rei M, Dobinson HC, Gibani MM, Teng KWW, Newell EW, Veerapen N, Besra GS, Pollard AJ, Cerundolo V. MAIT cell clonal expansion and TCR repertoire shaping in human volunteers challenged with Salmonella Paratyphi A. Nat Commun. 2018 Jan 17;9(1):253. doi: 10.1038/s41467-017-02540-x.
- Derived from this study: PubMed 26082464McCullagh D, Dobinson HC, Darton T, Campbell D, Jones C, Snape M, Stevens Z, Plested E, Voysey M, Kerridge S, Martin LB, Angus B, Pollard AJ. Understanding paratyphoid infection: study protocol for the development of a human model of Salmonella enterica serovar Paratyphi A challenge in healthy adult volunteers. BMJ Open. 2015 Jun 16;5(6):e007481. doi: 10.1136/bmjopen-2014-007481.
- Related InfoLink provided by the sponsor.
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, MBBS principal investigator
Oxford Vaccine Group
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 enterica serovar Paratyphi A (strain NVGH308) in people with Enteric Fever Caused by Salmonella Enterica Serovar Paratyphi A, 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 12 inclusion and 46 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 14 Mar 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?
Clinical or microbiologically proven paratyphoid infection. (time frame: Up to 14 days after challenge dose administered). 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 NCT02100397, which also lists 4 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 14 Mar 2022.