There will be no specific condition investigated in this study
Conditions
Interventions
For oral cholera vaccination Dukoral will be used, combined with recombinant
cholera toxin subunit B. Subjects will receive a dose (3 mL) at Day 1 and at
Day 14. At Day 18, nasal rechallenge with th
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any mandated procedure. 2. Healthy male and female subjects, 18 to 45 years of age, inclusive at screening. 3. Body mass index (BMI) between 18 and 35 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, haematology 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 2 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 willing to comply with the study restrictions.
Exclusion criteria
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 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 5 half lives prior to the first oral cholera vaccination, 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 participant was enrolled in an investigational drug or device study within 90 days prior to 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). 11. The participant has lost or donated more than 400 mL of blood or blood products within 90 days prior to start of MMF or placebo treatment (Day -2) or plans to donate blood during the study. 12. The participant has had an acute, clinically significant illness or intervention by surgeon or dentist within 14 days prior to screening. 13. Current (or within past 6 months) nicotine use in excess of 5 cigarettes per day, or unable not to smoke during visits. 14. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 14 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent. 15. Previous vaccination against cholera or enterotoxigenic Escherichia coli. 16. Travel in the last 3 years to a country where cholera or enterotoxigenic E. coli is prevalent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Serum cholera antigen specific IgA levels at Day 1, 14, 18, 20 and 28. • Serum cholera antigen specific IgG levels at Day 1, 14, 18, 20 and 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Cholera antigen specific IgA in nasal secretion (measured by nasosorption) at -2 hours before and 1, 2, 7 and 10 days after nasal rechallenge. • Treatment-emergent (serious) adverse events (S)AEs. • Clinical safety laboratory measurements. • Vital signs measurements. • Physical examinations. | — |
Countries
Netherlands
Outcome results
None listed