EUCTR2011-004804-38-SE进行中（未招募）1 期
A Randomized, Blinded, Placebo-Controlled, Poliovirus Challenge Study To Evaluate The Therapeutic Efficacy, Safety, Tolerability And Pharmacokinetics Of Orally Administered V-073 In Healthy Adult Volunteers Receiving Type 1 Monovalent Oral Poliovirus Vaccine (mOPV1).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Be a healthy, non-smoking male or female of any race, having received prior vaccination with inactivated polio vaccine, and at
- •least 18 years old and no more than 50 years old, inclusively;
- •2. Have a body mass index (BMI) within the range of >18.5 and <30 unless
- •approved by the Sponsor and Investigator;
- •3. Be healthy as determined by pre study medical history, physical examination,
- •12 lead ECG and clinical laboratory evaluations;
- •4. Be positive for total serum IgA (indicative of immunocompetence);
- •5. Be negative for poliovirus-specific serum IgA (serotype 1) (indicative of no prior exposure to live poliovirus);
- •6. Have no history of immunodeficiency;
- •7. Have regular bowel movements, at least once per day (self reported);
- •8. Be informed of the nature of the study and provide written informed consent;
- •9. Be legally competent and able to communicate effectively with study personnel.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 144
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A history of natural or OPV-derived poliovirus infection;
- •2. Female subjects who are pregnant, attempting to become pregnant or lactating;
- •3. Any disease or condition that might compromise the cardiovascular,
- •hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine
- •(e.g., diabetes), central nervous, or gastrointestinal (including a gastric or
- •duodenal ulcer) systems;
- •4. The presence of clinically significant abnormal laboratory values in the opinion
- •of the Investigator or Sponsor;
- •5. A history of alcoholism or drug addiction within the past 2 years, recent use of
- •any recreational drugs, or positive results from a urine screen for substances of
- •abuse and alcohol at screening and admission;
- •6. A history of serious mental illness, that includes but is not limited to
- •schizophrenia, bipolar disorder, or severe depression requiring hospitalization or
- •pharmacological intervention;
- •7. Is a member of a household in which another member is known to be
- •immunodeficient or is actively being treated for a malignancy, autoimmune
- •disease or transplant;
- •8. A history of difficulty donating blood or inadequate venous access;
- •9. The donation of blood or plasma within 30 days prior to receiving study drug;
- •10. Lactose intolerant;
- •11. A positive hepatitis screen that tests for both hepatitis B surface antigen (HBsAg)
- •and antibody to hepatitis C (HCV);
- •12. A positive test result for HIV antibody by enzyme immunoassay which is
- •confirmed by Western immunoblot;
- •13. Receipt of an investigational drug or product, or participation in a drug study
- •within a period of 30 days prior to receiving study drug (for investigational drugs
- •with an elimination half-life greater than 10 days, this will be extended to 60
- •14. Use of any drug or medication known to suppress/inhibit the immune system
- •(e.g., steroids such as prednisone);
- •15. Use of a drug therapy known to induce or inhibit hepatic drug metabolism within
- •30 days prior to receiving study drug or during the study.
- •16. Use of any prescription or over-the-counter (OTC) drug therapy, excluding
- •paracetamol and including herbal, homeopathic, vitamins, minerals and
- •nutritional supplements, unapproved by the Sponsor, within 2 weeks prior to
- •receiving the study drug (for drugs with an elimination half-life greater than 10
- •days, this will be extended to 60 days).
- •17. Use of grapefruits and grapefruit-containing juices within 1 week prior to dosing.
- •18. Unable to follow the restrictions outlined in the protocol ; or judgment by the PI that the subject should not participate in the study;
研究者
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