A randomized, single-blind, placebo-controlled study to evaluate an oral cholera vaccination with intranasal rechallenge as an adaptive immune challenge model

Centre for Human Drug Research0 sites16 target enrollmentMay 4, 2023

ConditionsOral cholera vaccination with intranasal rechallenge as an adaptive immune challenge model Not Applicable

Overview

Phase: 未知
Intervention: Not specified
Conditions: Oral cholera vaccination with intranasal rechallenge as an adaptive immune challenge model
Sponsor: Centre for Human Drug Research
Enrollment: 16
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 4, 2023

End Date

June 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Centre for Human Drug Research

Eligibility Criteria

Inclusion Criteria

•1\. Signed informed consent prior to any mandated procedure
•2\. Healthy male and female volunteers, 18 to 45 years of age, inclusive at screening
•3\. Body mass index (BMI) between 18 and 30 kg/m², inclusive, and with a minimum weight of 50 kg
•4\. All subjects must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment
•5\. The participant has clinical laboratory evaluations (including clinical chemistry, hematology and complete urine analysis) within the reference range for the testing laboratory, unless the results are deemed not clinically significant by the investigator
•6\. Participants who are overtly healthy as determined by medical evaluation including medical history, vital signs, physical examination, laboratory tests and ECGs at Screening and on Day \-2
•7\. The participant should be able to take MMF/placebo two times per day for 6 days and to refrain from eating 2 hours before intake
•8\. Has the ability to communicate well with the Investigator in the Dutch language and is willing to comply with the study restrictions

Exclusion Criteria

•1\. The participant has signs and/or symptoms of an infection 2 weeks prior to dosing, or recurrent infection, or has had an infection requiring antibiotic treatment (e.g. sepsis, pneumonia, abscess) within 42 days prior to the start of MMF/placebo administration
•2\. The participant has (a history of) autoimmune disease such as multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis or other immune\-inflammatory disease
•3\. The participant has a history of trauma with likely damage to the spleen, or has had surgery to the spleen or splenectomy
•4\. The participant has a known immunodeficiency
•5\. Positive Hepatitis B surface antigen (HBsAg), anti\-hepatitis B core, hepatitis C, or human immunodeficiency virus antibody (HIV\-Ab) at screening
•6\. Serious psychiatric or medical conditions that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give consent.
•7\. The participant has taken any over\-the\-counter (OTC) or any prescription medication (with the exception of paracetamol) less than 14 days or 5 half\-lives (whichever is longer) prior to the first IMP dosing, and considered as relevant by the investigator
•8\. Participant has received live attenuated vaccination within 42 days prior to Screening or intends to have vaccinations during the course of the study. SARS\-CoV\-2 vaccinations are not allowed 1 week prior to Screening and from 2 weeks before dosing until EOS
•9\. Participant has received any investigational drug of experimental procedure within 90 days or 5 half\-lives, whichever is longer, prior to study intervention administration, or the participant was enrolled in an investigational drug or device study within 90 days prior to the first IMP dosing
•10\. The participant has a history of hypersensitivity or allergies to any drug or to any of the components of the study interventions (i.e. Dukoral oral cholera vaccination, MMF or placebo)