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CompletedNCT04349553Updated Aug 17, 2025Results posted

Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine

A Phase 1 interventional study of ZH9PA and ZH9 and Placebo in Enteric Fever, sponsored by Prokarium Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Prokarium Ltd · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Enteric Fever

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03

In context

Typhoid Fever

74 studies on the registry are indexed under Typhoid Fever; 10 are open to participants now.

This study's enrollment of 46 is below the median of 149 across 64 interventional studies indexed under Typhoid Fever.

Browse Typhoid Fever studies →

Lead sponsor

Prokarium Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

To be confirmed at Screening

  1. Healthy male and female participants 18 to 45 years of age, inclusive.
  2. 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).
  3. 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).
  4. Female participant of childbearing potential or non-childbearing potential with a negative pregnancy test at Screening.
  5. 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.
  6. 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.
  7. Participant with a body mass index (BMI) of ≥ 19 or ≤34 kg/m\^2 (BMI = body weight (kg) / [height (m)]\^2).
  8. No clinically significant history of liver or active gall bladder disease.
  9. No clinically significant history of ongoing gastro-intestinal disease or abnormality.
  10. No clinically significant history of previous allergy / sensitivity to ZH9/ZH9PA or sodium bicarbonate.
  11. No clinically significant history of anaphylactic shock following vaccination.
  12. No clinically significant history of hypersensitivity (e.g., hives/rash/swollen lips/difficulty with breathing) to azithromycin, ampicillin, trimethoprim-sulfamethoxazole or ciprofloxacin.
  13. 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.
  14. 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).
  15. Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg)) and hepatitis C virus antibody (HCV Ab) test results at Screening.
  16. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) or vital signs determined within 28 days before first dose of IMP.
  17. Participant must be available to complete the study (including all follow up visits).
  18. Participant must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
  19. Participant must provide written informed consent to participate in the study.

To be re-confirmed on Day 0 / prior to each dosing visit

  1. Participant continues to meet all screening inclusion criteria.
  2. 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).
  3. Female participant of childbearing potential or non-childbearing potential with a negative pregnancy test on admission.

Exclusion criteria

Exclusion Criteria:

To be confirmed at Screening:

  1. 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.
  2. Participant with a history of heart disease or of rheumatic fever.
  3. 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).
  4. 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.
  5. Participant with sickle cell anaemia.
  6. Participant who has undertaken a course of antibiotics/antibacterials within 28 days prior to each dose of IMP (Days 0, 21 and 42).
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. Vaccination against Typhoid within 3 years prior to first dose of IMP.
  12. Ingestion of Typhoid bacteria in a challenge study within 3 years prior to dosing.
  13. Participant who works as a commercial food handler.
  14. Participant who is a health care worker in direct contact with patients.
  15. Participant who is a childcare worker.
  16. Participant who has household contact with immuno-compromised individuals, pregnant women, children \< 2 years of age or individuals > 70 years of age.
  17. 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.
  18. 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).
  19. Participant who is a current smoker (cigarettes, tobacco and/or e-cigarettes) or has stopped smoking in the last 3 months prior to Screening.
  20. 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.
  21. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).
  22. 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).
  23. Donation of 450 millilitres (mL) or more blood within the 3 months before the first dose of IMP.
  24. 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:

  1. Development of any exclusion criteria since the Screening visit.
  2. 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.
  3. Participation in a clinical study since Screening.
  4. Donation of 450 mL or more blood since Screening.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    ZH9PA 1x10^9 CFU

    1mL ZH9PA 1x10\^9 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration

    Biological: Placebo · Biological: ZH9PA

  • Experimental
    ZH9PA 1x10^10 CFU

    1mL ZH9PA 1x10\^10 CFU suspension in normal saline will be mixed with sodium bicarbonate 2%w/v to produce 150mL for oral administration

    Biological: Placebo · Biological: ZH9PA

  • Experimental
    ZH9PA 1x10^10 CFU plus ZH9 1x10^10 CFU

    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

    Biological: ZH9PA and ZH9 · Biological: Placebo

  • Placebo comparator
    Placebo

    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

    Biological: ZH9PA and ZH9 · Biological: Placebo · Biological: ZH9PA

Interventions

  • BiologicalZH9PA and ZH9

    150mL vaccine for oral administration

    Also known as: Entervax

  • BiologicalPlacebo

    150mL vaccine for oral administration

  • BiologicalZH9PA

    150mL vaccine for oral administration

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From Day 0 to Day 84

  2. 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

    Time frame: From Day 0 to Day 84

Secondary outcomes

  1. Number of Participants With Serious Adverse Events

    Incidence of Serious adverse events

    Time frame: From Day 85 to Day 224

  2. 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.

    Time frame: From Day 85 to Day 224

  3. 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

    Time frame: Day 0, Day 21, Day 42, and Day 84

  4. 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

    Time frame: Day 0, Day 21, Day 42, and Day 84

  5. 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

    Time frame: Day 0, Day 21, Day 42, and Day 84

  6. 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

    Time frame: Day 0, Day 21, Day 42, and Day 84

07

Results

Posted Aug 17, 2025

Participant flow

Forty-six (46) subjects (45 and 1 replacement) were enrolled into the study and dosed. The study started (first visit) on 16 December 2019 and recruitment was completed by 19 June 2020.

Participant flow — Overall Study
MilestoneZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlacebo
Started7121215
Completed6121115
Not completed1010
Withdrew: Withdrawal by subject1010

Outcome measures

PrimaryNumber 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.

Time frame:
From Day 0 to Day 84
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events
ParticipantsZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlacebo
Number of Participants With Treatment Emergent Adverse Events4989
PrimaryNumber 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

Time frame:
From Day 0 to Day 84
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests
ParticipantsZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlacebo
Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests0000
SecondaryNumber of Participants With Serious Adverse Events

Incidence of Serious adverse events

Time frame:
From Day 85 to Day 224
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events
ParticipantsZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlacebo
Number of Participants With Serious Adverse Events0000
SecondaryNumber 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.

Time frame:
From Day 85 to Day 224
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests
ParticipantsZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlacebo
Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests0000
SecondaryFold-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

Time frame:
Day 0, Day 21, Day 42, and Day 84
Reported as:
Mean · Fold-Increase
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:a
Fold-IncreaseZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlacebo
Day 210.984 (0.594 to 1.375)1.470 (1.194 to 1.746)1.106 (0.817 to 1.394)1.055 (0.808 to 1.302)
Day 421.346 (-1.721 to 4.414)4.522 (2.353 to 6.691)1.349 (-0.917 to 3.614)1.119 (-0.822 to 3.059)
Day 841.643 (-0.812 to 4.098)4.968 (3.232 to 6.704)2.417 (0.604 to 4.230)1.372 (-0.181 to 2.925)
SecondaryFold-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

Time frame:
Day 0, Day 21, Day 42, and Day 84
Reported as:
Mean · Fold-Increase
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen H:d
Fold-IncreaseZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlacebo
Day 21——8.068 (6.760 to 9.376)0.878 (-0.374 to 2.130)
Day 42——6.783 (5.731 to 7.836)0.838 (-0.170 to 1.846)
Day 84——5.819 (4.693 to 6.946)0.875 (-0.204 to 1.953)
SecondaryFold-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

Time frame:
Day 0, Day 21, Day 42, and Day 84
Reported as:
Mean · Fold-Increase
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:2
Fold-IncreaseZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlacebo
Day 212.489 (-5.270 to 10.248)4.466 (-1.020 to 9.953)15.858 (10.127 to 21.589)0.964 (-3.943 to 5.872)
Day 423.061 (-0.658 to 6.780)3.305 (0.675 to 5.935)8.877 (6.130 to 11.624)0.939 (-1.413 to 3.292)
Day 842.621 (1.157 to 4.085)2.759 (1.723 to 3.794)4.386 (3.305 to 5.468)1.024 (0.098 to 1.950)
SecondaryFold-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

Time frame:
Day 0, Day 21, Day 42, and Day 84
Reported as:
Mean · Fold-Increase
Fold-Increase Serum IgG Antibody Concentration of Specific Serum Immunoglobulin (Ig)G Antibodies to the Antigen LPSO:9
Fold-IncreaseZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlacebo
Day 21——19.292 (5.265 to 33.320)1.005 (-12.425 to 14.436)
Day 42——11.103 (4.275 to 17.931)0.845 (-5.692 to 7.383)
Day 84——9.686 (3.074 to 16.297)0.998 (-5.332 to 7.328)

Adverse events

Collected over Up to 12 weeks post-dose (Day 84). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ZH9PA 1x10^9 CFU0/7 (0%)0/7 (0%)4/7 (57.1%)
ZH9PA 1x10^10 CFU0/12 (0%)0/12 (0%)9/12 (75%)
ZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFU0/12 (0%)0/12 (0%)8/12 (66.7%)
Placebo0/15 (0%)0/15 (0%)9/15 (60%)
Most frequent other events
Showing 10 of 23
Most frequent other events
EventZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlacebo
HeadacheNervous system disorders0/74/123/124/15
NasopharyngitisInfections and infestations0/72/120/122/15
VomitingGastrointestinal disorders1/71/122/120/15
DiarrhoeaGastrointestinal disorders1/70/122/120/15
Abdominal painGastrointestinal disorders1/71/121/120/15
Oropharyngeal painRespiratory, thoracic and mediastinal disorders1/71/120/121/15
DyspepsiaGastrointestinal disorders1/70/120/120/15
Influenza like illnessGeneral disorders1/70/120/120/15
Taste disorderNervous system disorders1/70/120/120/15
NauseaGastrointestinal disorders0/71/121/121/15

Baseline characteristics

Age, Continuous
Age, Continuous(years)ZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlaceboTotal
Mean33.4 ± 3.6933.0 ± 7.8734.4 ± 5.8136.9 ± 5.5234.7 ± 6.12
Sex: Female, Male
Sex: Female, Male(Participants)ZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlaceboTotal
Female357318
Male4751228
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlaceboTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White612121444
More than one race00000
Unknown or Not Reported10012
Region of Enrollment
Region of Enrollment(Participants)ZH9PA 1x10^9 CFUZH9PA 1x10^10 CFUZH9PA 1x10^10 CFU Plus ZH9 1x10^10 CFUPlaceboTotal
United Kingdom712121546
08

Study locations

1 site
  • Simbec Research
    Merthyr Tydfil, Wales CF48 4DR, United Kingdom
09

References and documents

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 documents

  • Protocol and statistical analysis plan · Jan 24, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04349553
Lead sponsor
Prokarium Ltd
Collaborators
Simbec Research
Responsible party
Sponsor
First posted
Apr 16, 2020
Start date
Dec 16, 2019
Primary completion
Sep 28, 2020
Completion
Feb 15, 2021
Results posted
Aug 17, 2025
Last update
Aug 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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