A study to evaluate the use of a cholera vaccine as an immune challenge for the mucosal immune system
- Conditions
- Oral cholera vaccination with intranasal rechallenge as an adaptive immune challenge modelNot Applicable
- Registration Number
- ISRCTN14583662
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 16
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
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)
11. The participant has lost or donated more than 400 ml of blood or blood products within 90 days prior to the 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 a surgeon or dentist within 14 days prior to screening
13. Current (or within the 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 of 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Systemic immune response is measured as serum cholera antigen specific IgA levels at Days 1, 14, 18, 20 and 28<br> 2. Systemic immune response is measured as serum cholera antigen specific IgG levels at Days 1, 14, 18, 20 and 28<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Local immune response is measured as saliva cholera antigen specific IgA levels at Days 1, 14, 18, 20 and 28<br> 2. Local immune response is measured as nasal cholera antigen specific IgA levels at Days w, 7 and 10<br>