NL-OMON53390
Completed
Not Applicable
A randomized, single-blind, placebo-controlled study to evaluate an oral cholera vaccination with intranasal rechallenge as adaptive immune challenge model - Cholera vaccination challenge
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- There will be no specific condition investigated in this study
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
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.
Outcomes
Primary Outcomes
Not specified
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