NL-OMON56012尚未招募不适用
Establishing a Controlled Human Infection Model (CHIM) with a Rhinovirus challenge agent in healthy volunteers - Rhinovirus CHIM validation study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
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 study-mandated procedure;
- •2. Healthy male or female volunteers, 18 to 49 years of age, inclusive at
- •screening; Good health is based upon the results of medical history, physical
- •examination, vital signs, ECG, and laboratory profiles of both blood and urine
- •3. A total body weight >=50 kg and body mass index (BMI) >=18.0 and <=30.0 kg/m2
- •at screening;
- •4. All women of child bearing potential and must practice effective
- •contraception during the course of the study;
- •5. Subject has adequate understanding of the procedures of the study and agrees
- •to abide strictly thereby;
- •6. Subject is able to communicate well in Dutch with the investigator, and
- •is willing to comply with the study procedures and restrictions;
- •7. Subject is able to tolerate the nasal wash procedure at screening;
- •8. Seronegative (Virus neutralizing titer <= 1:6) for RV16 at screening for part
- •A; seropositive for RV16 (VNT >1:6) at screening in part B;
- •9. Willingness to stay in self-quarantine between baseline visit and day of
- •inoculation.
排除标准
- •1. Any history or evidence of any clinically significant or currently active
- •major disease, or condition that, in the opinion of the investigator, may
- •interfere with a subject completing the study and the necessary investigations
- •(following a detailed medical history, physical examination, vital signs
- •(systolic and diastolic blood pressure, and body temperature) and ECG). Minor
- •deviations from the normal range may be accepted, if judged by the investigator
- •to have no clinical relevance;
- •2. Clinically significant abnormalities, as judged by the investigator, in
- •laboratory test results (including blood biochemistry, hematology and
- •urinalysis). In the case of uncertain or questionable results, tests performed
- •during screening may be repeated before inclusion to confirm eligibility or
- •judged to be clinically irrelevant;
- •3. Chronic respiratory disease (asthma, emphysema, COPD, chronic rhinitis or
- •sinusitis or other reactive airway diseases) in adulthood. Childhood asthma and
- •non-active allergic rhinitis (including hay fever) will be permitted at the
- •discretion of the investigator;
- •4. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),
- •or human immunodeficiency virus antibody (HIV Ab) at screening;
- •5. Any confirmed or suspected disease or condition associated with immune
- •system impairment, including auto-immune diseases, HIV, asplenia or recurrent
- •severe infections;
- •6. Prior inoculation with a virus from the same virus family as the challenge
- •7. Prior participation in another controlled human infection study with a
- •respiratory virus in the preceding 6 months taken from the date of viral
- •challenge in the previous study to the date of expected viral challenge in this
- •8. Participation in an investigational medical product, vaccine or device study
- •within 3 months or 5 half-lives prior to the study period (whichever is
- •longer), or more than 4 times in the past year;
- •9. Any known history of anaphylaxis or any significant allergy against the
- •excipients of the virus challenge inoculum;
- •10. Any anatomic or neurologic abnormality impairing the gag reflex, or
- •associated with an increased risk of aspiration, or any abnormality
- •significantly altering the anatomy of the nose or nasopharynx in a
- •substantial way that may interfere with the aims of the study and
- •in particular any of the nasal assessments or viral challenge;
- •11. History of frequent epistaxis (nose bleeds) in the six months prior to
- •inoculation and/or any history of being hospitalized due to epistaxis;
- •12. Any nasal or sinus surgery within 3 months prior to the viral challenge;
- •13. Upper or lower respiratory tract infection or febrile illness (temperature
- •>=37.9°C), in the period of 2 weeks prior to the viral challenge;
- •14. Symptoms of active hay fever or other allergies that involve the airways,
- •during screening, prior to inoculation or expected during the investigational
- •period based on prior seasonality;
- •15. Use of any medications (prescription or over-the-counter [OTC]), within 14
- •days prior to virus inoculation, or less than 5 half-lives (whichever is
- •longer), and during the course of the study. Exceptions are paracetamol (up to
- •4 gram/day) and contraceptives. Other exceptions will only be made if the
- •rationale is clearly documented and accepted by the investigator.
研究者
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