Enteric FeverPhase 1NCT04349553
Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine
A Phase 1 study testing ZH9PA and ZH9 and ZH9PA in people with Enteric Fever, run by Prokarium Ltd at 1 site in United Kingdom.
Trial summary
A Phase 1, randomised, double-blind, placebo-controlled, parallel group study in 45 healthy participants aged 18 to 45 years inclusive. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Enteric Fever
- What is being tested?
- ZH9PA and ZH9 and ZH9PA
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Dec 2019to 15 Feb 2021
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be confirmed at Screening
- Healthy male and female participants 18 to 45 years of age, inclusive.
- Female participant of childbearing potential willing to use 2 effective methods of contraception, i.e., established method of contraception + condom, if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from the first dose until 2 months after the last dose of Investigational Medicinal Product (IMP).
- Female participant of non-childbearing potential. For the purposes of this study, this is defined as the participant being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy).
- Female participant of childbearing potential or non-childbearing potential with a negative pregnancy test at Screening.
- Female participant of post-menopausal status confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range. In the event a participant's menopausal status has been clearly established (for example, the participant indicates she has been amenorrhoeic for 10 years, confirmed by medical history, etc), but serum FSH levels are not consistent with a postmenopausal status, determination of the participant's eligibility to be included in the study will be at the Investigator's discretion following consultation with the Sponsor.
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- Male participant willing to use an effective method of contraception or 2 effective methods of contraception, i.e., established method of contraception + condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from first dose until a stool sample tested for presence of the vaccine strains is negative.
- Participant with a body mass index (BMI) of ≥ 19 or ≤34 kg/m^2 (BMI = body weight (kg) / [height (m)]^2).
- No clinically significant history of liver or active gall bladder disease.
- No clinically significant history of ongoing gastro-intestinal disease or abnormality.
- No clinically significant history of previous allergy / sensitivity to ZH9/ZH9PA or sodium bicarbonate.
- No clinically significant history of anaphylactic shock following vaccination.
- No clinically significant history of hypersensitivity (e.g., hives/rash/swollen lips/difficulty with breathing) to azithromycin, ampicillin, trimethoprim-sulfamethoxazole or ciprofloxacin.
- No clinically significant abnormal laboratory test results (in the opinion of the investigator) for serum biochemistry, haematology and/or urine analyses within 28 days before receiving the first dose administration of the IMP.
- Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol and cotinine) test results, determined within 28 days before the first dose administration of the IMP unless there is a documented medical explanation for the positive result other than drugs of abuse (e.g., the participant has been prescribed opioids for pain). (N.B.: A positive test result may be repeated at the Investigator's discretion).
- Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg)) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- No clinically significant abnormalities in 12-lead electrocardiogram (ECG) or vital signs determined within 28 days before first dose of IMP.
- Participant must be available to complete the study (including all follow up visits).
- Participant must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
- Participant must provide written informed consent to participate in the study.
- To be re-confirmed on Day 0 / prior to each dosing visit
- Participant continues to meet all screening inclusion criteria.
- Participant with a negative urinary drugs of abuse screen (including alcohol and cotinine) prior to dosing unless there is a documented medical explanation for the positive result other than drugs of abuse (e.g., the participant has been prescribed opioids for pain). (N.B.: A positive test result may be repeated at the Investigator's discretion).
- Female participant of childbearing potential or non-childbearing potential with a negative pregnancy test on admission.
Who cannot join
- To be confirmed at Screening:
- Participant with any clinically significant medical (cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, autoimmune disease or current infection) or psychiatric condition (see also exclusion criterion number 21) that, in the opinion of the Investigator, precludes participation in the study. This will include any clinically significant abnormal serum biochemistry results and/or haematological results and/or urine analytical results.
- Participant with a history of heart disease or of rheumatic fever.
- Participant with a significant acute febrile illness (including fever of 38.0^0C or greater within 14 days) of each dose of IMP (Days 0, 21 and 42).
- Participant who has chronic diseases: Chronic diseases will include all autoimmune and immunocompromising conditions and any other chronic condition, which at the judgment of the Investigator, may put the participant at higher risk of side effects from the study vaccine. Conditions in the latter category might include unexplained anaemia, hepato-biliary disease, uncontrolled hypertension, participant with prosthetic joints or heart valves, etc.
- Participant with sickle cell anaemia.
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- Participant who has undertaken a course of antibiotics/antibacterials within 28 days prior to each dose of IMP (Days 0, 21 and 42).
- Use of prescription or non-prescription drugs within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of IMP, unless in the opinion of the Investigator and Sponsor's Responsible Physician the medication will not interfere with the study procedures or compromise participant safety.
- Participant who uses antacids, proton pump inhibitors or H2 blockers on a regular basis or has consumed proton pump inhibitors or H2 blockers within 24 hours prior to each dose of IMP.
- Participant who has received investigational or licensed vaccines in the 28 days prior to dosing or anticipates receiving a vaccine other than study medication up to Day 84 of the study.
- Participant with symptoms consistent with Typhoid fever concurrent with travel to countries where typhoid infection is endemic (most of the developing world) within 2 years prior to first dose of IMP.
- Vaccination against Typhoid within 3 years prior to first dose of IMP.
- Ingestion of Typhoid bacteria in a challenge study within 3 years prior to dosing.
- Participant who works as a commercial food handler.
- Participant who is a health care worker in direct contact with patients.
- Participant who is a childcare worker.
- Participant who has household contact with immuno-compromised individuals, pregnant women, children < 2 years of age or individuals > 70 years of age.
- Participant who has person(s) living with him/her who, in the opinion of the Investigator, may be at risk of disease if exposed to the vaccine strain.
- Participant with a known impairment of immune function or receiving (or has received in the 6 months prior to study entry) cytotoxic drugs or immunosuppressive therapy (including systemic corticosteroids).
- Participant who is a current smoker (cigarettes, tobacco and/or e-cigarettes) or has stopped smoking in the last 3 months prior to Screening.
- A clinically significant history of drug or alcohol abuse [defined as the consumption of more than 14 units of alcohol a week] within the past two years prior to Screening.
- Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between receiving the last dose of the previous study and receiving the first dose of the next study).
- Donation of 450 millilitres (mL) or more blood within the 3 months before the first dose of IMP.
- Participant who, in the opinion of the Investigator, is unsuitable for participation in the study.
- To be re-confirmed at Day 0 / prior to each dosing visit:
- Development of any exclusion criteria since the Screening visit.
- Use of prescription or non-prescription drugs since Screening, unless in the opinion of the Investigator and Sponsor's Responsible Physician, the medication will not interfere with the study procedures or compromise participant safety.
- Participation in a clinical study since Screening.
- Donation of 450 mL or more blood since Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Oral Enteric Fever Vaccine (ZH9 + ZH9PA) in Healthy Participants
A Phase 1, randomised, double-blind, placebo-controlled, parallel group study in 45 healthy participants aged 18 to 45 years inclusive.
Read the detailed description
This is a Phase I, randomised, double-blind, placebo-controlled, parallel group, single-centre study involving 45 healthy participants. The aim is to evaluate the safety and immunogenicity of Entervax, a combination vaccine against enteric fever comprising Typhi ZH9 (hereafter ZH9) plus an engineered derivative that will provide an immune response to the key antigens (LPS 0:2 and H:a flagella) from S. Paratyphi A (hereafter ZH9PA). ZH9PA has not previously been tested in humans therefore the first two cohorts comprise a dose escalation of ZH9PA and the final cohort comprises a single dose level of the combination of ZH9PA and ZH9.
- Conditions
- Enteric Fever
- Being tested
- ZH9PA and ZH9, Placebo, ZH9PA
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZH9PA and ZH9Biological
Also called Entervax
150mL vaccine for oral administration
PlaceboBiological
150mL vaccine for oral administration
ZH9PABiological
150mL vaccine for oral administration
| Study group | Role | What they receive |
|---|---|---|
| ZH9PA 1x10^9 CFU | Experimental | 1mL ZH9PA 1x10^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration Receives: Biological: Placebo; Biological: ZH9PA |
| ZH9PA 1x10^10 CFU | Experimental | 1mL ZH9PA 1x10^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration Receives: Biological: Placebo; Biological: ZH9PA |
| ZH9PA 1x10^10 CFU plus ZH9 1x10^10 CFU | Experimental | 1mL ZH9PA 1x10^10 CFU suspension in normal saline and 1mL ZH9 1x10^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration Receives: Biological: ZH9PA and ZH9; Biological: Placebo |
| Placebo | Placebo comparator | 1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration Receives: Biological: ZH9PA and ZH9; Biological: Placebo; Biological: ZH9PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
Number of adverse events as assessed by adverse events, laboratory safety tests (biochemistry, haematology, urinalysis), vital signs and physical examination.
Measured: From Day 0 to Day 84
Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests
Tests include blood pressure, heart rate, physical examination, laboratory biochemistry, haematology and urinalysis tests
Measured: From Day 0 to Day 84
Secondary outcomes (6)
Number of Participants With Serious Adverse Events
Incidence of Serious adverse events
Measured: From Day 85 to Day 224
Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests
Tests include blood pressure, heart rate, physical examination, laboratory biochemistry, haematology and urinalysis tests if these assessments are undertaken for cause.
Measured: From Day 85 to Day 224
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:a
Fold Increase Serum IgG Antibody Concentration of specific serum immunoglobulin (Ig)G antibodies to the antigen H:a
Measured: Day 0, Day 21, Day 42, and Day 84
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:d
Fold Increase Serum IgG Antibody Concentration of specific serum immunoglobulin (Ig)G antibodies to the antigen H:d
Measured: Day 0, Day 21, Day 42, and Day 84
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:2
Fold Increase Serum IgG Antibody Concentration of specific serum immunoglobulin (Ig)G antibodies to the antigen LPSO:2
Measured: Day 0, Day 21, Day 42, and Day 84
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:9
Fold Increase Serum IgG Antibody Concentration of specific serum immunoglobulin (Ig)G antibodies to the antigen LPSO:9
Measured: Day 0, Day 21, Day 42, and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start16 Dec 2019
- Primary completion28 Sep 2020
- Study completion15 Feb 2021
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 Enteric FeverStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort 1 will consist of 9 participants, who will receive 3 doses of 1x10\^9 Colony Forming Units (CFU) of ZH9PA (6 participants) or placebo (3 participants). Cohort 2 will consist of 18 participants, who will receive 3 doses of 1x10\^10 CFU of ZH9PA (12 participants) or placebo (6 participants). Cohort 3 will consist of 18 participants, who will receive 3 doses of 1x10\^10 CFU of ZH9PA and 1x10\^10 CFU of ZH9 (12 participants) or placebo (6 participants).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prokarium Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349553
- Sponsor's protocol ID
- PRK-ENT-001
- Status last verified
- Jul 2025
- First submitted
- 11 Jan 2020
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soulier A, Prevosto C, Chol M, Deban L, Cranenburgh RM. Engineering a Novel Bivalent Oral Vaccine against Enteric Fever. Int J Mol Sci. 2021 Mar 23;22(6):3287. doi: 10.3390/ijms22063287.
PubMed 33807097
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Oral Enteric Fever Vaccine (ZH9 + ZH9PA) in Healthy Participants
- ClinicalTrials.gov ID
- NCT04349553
- Acronym / sponsor ID
- PRK-ENT-001
- Conditions
- Enteric Fever
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Prokarium LtdIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, randomised, double-blind, placebo-controlled, parallel group study in 45 healthy participants aged 18 to 45 years inclusive.
Detailed description
This is a Phase I, randomised, double-blind, placebo-controlled, parallel group, single-centre study involving 45 healthy participants. The aim is to evaluate the safety and immunogenicity of Entervax, a combination vaccine against enteric fever comprising Typhi ZH9 (hereafter ZH9) plus an engineered derivative that will provide an immune response to the key antigens (LPS 0:2 and H:a flagella) from S. Paratyphi A (hereafter ZH9PA). ZH9PA has not previously been tested in humans therefore the first two cohorts comprise a dose escalation of ZH9PA and the final cohort comprises a single dose level of the combination of ZH9PA and ZH9.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Cohort 1 will consist of 9 participants, who will receive 3 doses of 1x10^9 Colony Forming Units (CFU) of ZH9PA (6 participants) or placebo (3 participants). Cohort 2 will consist of 18 participants, who will receive 3 doses of 1x10^10 CFU of ZH9PA (12 participants) or placebo (6 participants). Cohort 3 will consist of 18 participants, who will receive 3 doses of 1x10^10 CFU of ZH9PA and 1x10^10 CFU of ZH9 (12 participants) or placebo (6 participants).
| Arm | Type | Receives |
|---|---|---|
| ZH9PA 1x10^9 CFU | Experimental | Biological: Placebo, Biological: ZH9PA1mL ZH9PA 1x10^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration |
| ZH9PA 1x10^10 CFU | Experimental | Biological: Placebo, Biological: ZH9PA1mL ZH9PA 1x10^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration |
| ZH9PA 1x10^10 CFU plus ZH9 1x10^10 CFU | Experimental | Biological: ZH9PA and ZH9, Biological: Placebo1mL ZH9PA 1x10^10 CFU suspension in normal saline and 1mL ZH9 1x10^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration |
| Placebo | Placebo comparator | Biological: ZH9PA and ZH9, Biological: Placebo, Biological: ZH9PA1mL (Cohorts 1 and 2) or 2mL (Cohort 3) normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- To be confirmed at Screening
- Healthy male and female participants 18 to 45 years of age, inclusive.
- Female participant of childbearing potential willing to use 2 effective methods of contraception, i.e., established method of contraception + condom, if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from the first dose until 2 months after the last dose of Investigational Medicinal Product (IMP).
- Female participant of non-childbearing potential. For the purposes of this study, this is defined as the participant being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy).
- Female participant of childbearing potential or non-childbearing potential with a negative pregnancy test at Screening.
Key exclusion criteria (30 listed)
- Participant with any clinically significant medical (cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, autoimmune disease or current infection) or psychiatric condition (see also exclusion criterion number 21) that, in the opinion of the Investigator, precludes participation in the study. This will include any clinically significant abnormal serum biochemistry results and/or haematological results and/or urine analytical results.
- Participant with a history of heart disease or of rheumatic fever.
- Participant with a significant acute febrile illness (including fever of 38.0^0C or greater within 14 days) of each dose of IMP (Days 0, 21 and 42).
- Participant who has chronic diseases: Chronic diseases will include all autoimmune and immunocompromising conditions and any other chronic condition, which at the judgment of the Investigator, may put the participant at higher risk of side effects from the study vaccine. Conditions in the latter category might include unexplained anaemia, hepato-biliary disease, uncontrolled hypertension, participant with prosthetic joints or heart valves, etc.
- Participant with sickle cell anaemia.
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 |
|---|---|---|
| ZH9PA and ZH9Also: Entervax150mL vaccine for oral administration | Biological | Placebo, ZH9PA 1x10^10 CFU plus ZH9 1x10^10 CFU |
| Placebo150mL vaccine for oral administration | Biological | Placebo, ZH9PA 1x10^10 CFU, ZH9PA 1x10^10 CFU plus ZH9 1x10^10 CFU, ZH9PA 1x10^9 CFU |
| ZH9PA150mL vaccine for oral administration | Biological | Placebo, ZH9PA 1x10^10 CFU, ZH9PA 1x10^9 CFU |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: From Day 0 to Day 84
Number of adverse events as assessed by adverse events, laboratory safety tests (biochemistry, haematology, urinalysis), vital signs and physical examination.
Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests
Time frame: From Day 0 to Day 84
Tests include blood pressure, heart rate, physical examination, laboratory biochemistry, haematology and urinalysis tests
6 secondary outcomes
Number of Participants With Serious Adverse Events
Time frame: From Day 85 to Day 224
Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests
Time frame: From Day 85 to Day 224
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:a
Time frame: Day 0, Day 21, Day 42, and Day 84
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:d
Time frame: Day 0, Day 21, Day 42, and Day 84
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:2
Time frame: Day 0, Day 21, Day 42, and Day 84
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:9
Time frame: Day 0, Day 21, Day 42, and Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33807097Soulier A, Prevosto C, Chol M, Deban L, Cranenburgh RM. Engineering a Novel Bivalent Oral Vaccine against Enteric Fever. Int J Mol Sci. 2021 Mar 23;22(6):3287. doi: 10.3390/ijms22063287.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZH9PA and ZH9 and ZH9PA in people with Enteric Fever, run by Prokarium Ltd 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 24 inclusion and 30 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 17 Aug 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 17 Aug 2025). 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 of Participants With Treatment Emergent Adverse Events (time frame: From Day 0 to Day 84). The study lists 2 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 NCT04349553, 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 17 Aug 2025.