PER-035-22招募中2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Double-dummy, Multicenter Trial Assessing the Efficacy and Safety of Two Dose Regimens of JNJ-64281802 for the Prevention of Dengue Infection.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 99
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
- 性别
- All
入选标准
- •1.Index Cases: Age: =1 years of age.
- •2.Type of Participant and Disease Characteristic
- •Must have laboratory-confirmed dengue infection:
- •a. Any DENV-associated signs and symptoms =72 hours of onset (according to Appendix 3: WHO Clinical Classification of Dengue Disease), AND
- •b. A positive DENV NS1 and/or PCR test result at screening at a hospital and/or at an HCC/HCP in the community where the study will be conducted. Test results performed by local standard-of-care =72 hours of screening may be used for screening of this study.
- •3.Informed Consent/Assent
- •Must sign an ICF (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •In case the index case has not reached the legal adult age per the local regulation, the signature of a legal representative of the index case will be required. Parent(s) (preferably both if available or as per local requirements) (or their legally acceptable representative) must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study as described in Section 10.6.3, Informed Consent Process and Assent Form.
- •4.Household Contacts
- •Edad: 16 or 18 (depending on the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive.
- •5.Type of Participant and Disease Characteristic
- •a. Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. This determination must be recorded in the participant's source documents.
- •b. Must have a blood pressure (after the participant was supine for =5 minutes):
- •For a participant between 16 and 18 years old: between 90 and 120 mm Hg systolic, extremes included, and =80 mm Hg diastolic at screening.
- •For a participant >18 years old: between 90 and 140 mmHg systolic, extremes included, and =90 mm Hg diastolic at screening.
- •Two repeat measurements are allowed in the absence of any other concerning health screening issues.
- •6.Weight: Must have a body mass index (BMI, weight in kg divided by the square of height in meters) between 18.0 and 33.0 kg/m2 (inclusive), and a body weight of =40.0 kg at screening.
- •7. Sex and Contraceptive/Barrier Requirements
- •a. Man or woman.
- •b. A woman must have a negative highly sensitive urine pregnancy test at screening.
- •c. A woman must be (as defined in Appendix 5: Contraceptive and Barrier Guidance )
- •* Not of childbearing potential.
- •* Of childbearing potential and practicing a highly effective, preferably user-independent method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until =90 days after the last dose, the end of relevant systemic exposure. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention.
- •Examples of highly effective methods of contraception are provided in Appendix 5: Contraceptive and Bar
排除标准
- •1. Medical Conditions
- •a. Having any DENV-associated clinical signs and symptoms (according to Appendix 3: WHO Clinical Classification of Dengue Disease).
- •b. History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator’s opinion could influence drug absorption or bioavailability [eg, constipation lasting >2 days]), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, autoimmune, or metabolic disturbances.
- •c. Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients (refer to the IB for JNJ-64281802 [IB JNJ-64281802 2021]).
- •d. Any clinically relevant skin disease (as assessed by the investigator) in the past 5 years such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria.
- •e. Having donated or lost >1 unit of blood (500 mL) within 60 days or >1 unit of plasma (250 mL) within 7 days before the planned first dose of study intervention, or having the intention to donate blood or blood products during the study or within 6 months after last dose of study intervention.
- •f. Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anticancer chemotherapy or radiation therapy.
- •g. History of risk factors for Torsades de Pointes (eg, heart failure, hypokalemia, family history of Long QT Syndrome).
- •h. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •2. Prior/Concurrent Clinical Study Experience
- •Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 6 months before the planned first dose of study intervention, or received an investigational biologic product within 3 months or 5 half-lives, whichever is longer, before the planned first dose of study intervention, or is currently enrolled in an investigational study.
- •3. Prior/Concomitant Therapy
- •a. Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy before the planned first dose of study intervention.
- •b. Use of any CYP3A4 inhibitors (eg, clarithromycin, itraconazole), CYP3A4 inducers (eg, phenytoin, rifampin), UGT1A9 inhibitors or inducers (eg, probenecid, rifampin, mefenamic acid), or substrates for CYP3A4 (eg, midazolam, triazolam), CYP2C8 (eg, repaglinide), CYP2C9 (eg, warfarin, tolbutamide), breast cancer resistance protein
- •(BCRP; eg, pravastatin and folic acid), or CYP2C19 (eg, S-mephenytoin, omeprazole) within 14 days before first dose of study intervention.
- •c. Received or plans to receive:
- •* Licensed live attenuated vaccines, from 28 days before first dose of study intervention until 90 days after last dose of study intervention.
- •* Other licensed (not live) vaccines, from 14 days before first dose of study intervention until 90 days after last dose of study intervention.
- •Vaccinations against DENV virus are not allowed prior to the first dose of study intervention until 90 days after last dose of study intervention. Vaccinations against all other flaviviruses are not allowed from 28 days before first dose of study intervention until 90 days after
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