NL-OMON53390已完成不适用
A randomized, single-blind, placebo-controlled study to evaluate an oral cholera vaccination with intranasal rechallenge as adaptive immune challenge model - Cholera vaccination challenge
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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
- •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.
排除标准
- •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.
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