CompletedPhase 1

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

United Kingdom46 participantsStarted 2019-12-16

Plain-language summary

A Phase 1, randomised, double-blind, placebo-controlled, parallel group study in 45 healthy participants aged 18 to 45 years inclusive.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events

Timeframe: From Day 0 to Day 84

Number of Participants With Abnormal Clinically or Non-clinically Significant or Out of Expected Range Tests

Timeframe: From Day 0 to Day 84

Trial details

NCT IDNCT04349553

SponsorProkarium Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-09-28

Results submitted2022-12-14

View on ClinicalTrials.gov More Enteric Fever trials