[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pertussis-whooping-cough\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pertussis-whooping-cough":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100630794","phase-1-a-phase-i-clinical-trial-of-absorbed-acellular-pertussis-two-component-diphtheria-tetanus-combined-vaccine-for-adults-and-adolescents-100630794",false,"NCT07492303","A Phase I Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)","A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Different Doses of Adsorbed Acellular Pertussis (Two-component) Diphtheria-tetanus Combined Vaccine (for Adults and Adolescents) in People Aged 10 Years and Older in a Randomized, Blinded, Placebo-controlled Manner","Inclusion Criteria:\n\n* People aged 10 years or older;\n* Study participants and\u002For their guardians\u002Fauthorized representatives are willing to provide valid identity certification documents of the study participants and\u002For their guardians\u002Fauthorized representatives;\n* Informed consent of the study participants themselves and\u002For their guardians\u002Fauthorized representatives shall be obtained, and informed consent forms shall be signed;\n* Study participants themselves and\u002For their guardians\u002Fauthorized representatives are able and willing to comply with the requirements of the clinical trial protocol and complete all trial follow-up visits;\n* Study participants aged 10 to 11 years have not received any vaccine containing any component of Diphtheria, Tetanus and Pertussis within 3 years; - study participants aged 12 years or older have not received any vaccine containing any component of Diphtheria, Tetanus and Pertussis within 5 years;\n* Women of childbearing potential have used effective contraceptive measures within 2 weeks prior to enrollment in this trial, have a negative urine pregnancy test before administration of the investigational vaccine (pregnancy test may be waived for non-childbearing potential women), and voluntarily agree to use effective contraceptive measures within 6 months after vaccination; male study participants must agree to use effective contraceptive methods with their female partners within 6 months after vaccination.\n\nExclusion Criteria:\n\n* Axillary body temperature \\>37.0°C on the day of enrollment of trial participants;\n* Female trial participants who are breastfeeding or pregnant, or trial participants or their partners who plan to conceive within 6 months;\n* Persons with severe cardiovascular diseases, uncontrolled hypertension (e.g., systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg for trial participants aged 18-59 years before enrollment, or systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg for trial participants aged 60 years and above) or other severe chronic diseases (for persons aged 18 years and above);\n* Persons with clinically significant abnormal results of pre-vaccination tests of blood routine, blood biochemistry, urine routine, and coagulation function indicators who are deemed unsuitable for vaccination by the investigator after comprehensive evaluation;\n* Persons with a confirmed history of diphtheria, tetanus, or pertussis within the past 5 years; or persons who have had close contact with individuals diagnosed with pertussis, diphtheria, or tetanus within the past 30 days;\n* Persons who have experienced persistent cough ≥14 days without fever in the absence of other specific etiologies (e.g., influenza) within the past 6 months;\n* Persons known to be allergic to any component of the investigational vaccine used in this clinical trial, or who had allergic reactions following previous administration of the same type of vaccine; persons with a history of severe allergy to any vaccine or drug, including but not limited to severe urticaria, anaphylactic shock, dyspnea, angioneurotic edema, anaphylactoid purpura, local allergic necrotizing reaction (Arthus reaction), etc.;\n* Persons with a history or family history of convulsions, epilepsy, encephalopathy (e.g., brain nerve tissue damage caused by congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, chemical drug poisoning, etc.), or mental illness;\n* Persons with primary or secondary immune impairment (e.g., severe history of or resection of thyroid, pancreas, liver, spleen, or kidney diseases, autoimmune diseases, malignant tumors, or requiring treatment for thyroid immune dysfunction diseases within the past 12 months);\n* Long-term use of immunosuppressants or other immunomodulatory drugs within 3 months before enrollment (e.g., prednisone or equivalent dose of similar drugs used at ≥0.5 mg\u002Fkg\u002Fday for trial participants aged 10-17 years, or ≥20 mg\u002Fday for trial participants aged 18-60 years, for 14 consecutive days or more);\n* Persons diagnosed by a physician with coagulation abnormalities (e.g., coagulation factor deficiency, coagulopathy, platelet abnormalities) or coagulation disorders;\n* Persons who have received immune globulin, blood or blood-related products within the past 3 months, plan to use such products during the trial, or have a history of blood transfusion within the past 3 months;\n* Persons with any acute infectious disease, febrile illness (axillary body temperature ≥38.0°C), cardiopulmonary disease (frequently occurring asthma), acute exacerbation of chronic diseases, or use of antipyretic, analgesic or antiallergic drugs within 3 days before vaccination;\n* Persons who have received other investigational drugs or vaccines within 1 month before vaccination, or plan to participate in or are currently participating in any other clinical trials;\n* Persons who have received live attenuated vaccines within 14 days before vaccination, or subunit vaccines or inactivated vaccines within 7 days before vaccination;\n* Persons with any other factors deemed unsuitable for participation in the clinical trial by the investigator.",true,"ALL","10 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","the safety and tolerability of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine",[27,28,29],"Pertussis (Whooping Cough)","Diphtheria","Tetanus","NOT_YET_RECRUITING","2026-03-19",{"date":33,"type":34},"2026-03-25","ACTUAL",{"date":36,"type":21},"2026-04-20",{"date":38,"type":21},"2027-08-20",{"name":40,"class":41},"Changchun BCHT Biotechnology Co.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100579682","phase-1-establishing-a-controlled-human-infection-model-of-pertactin-deficient-bordetella-pertussis-100579682","NCT06827470","Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis","Open-label, Phase 1\u002F2, Dose-escalation Clinical Trial to Establish a Controlled Human Infection Model by Determining and Confirming the Optimal and Safe J820 Bordetella Pertussis Dose Administered Intranasally to Healthy Adults 18-50 Years of Age That Induces Mild Symptomatic Infection and Detection of B. Pertussis in Nasal Samples","Inclusion Criteria:\n\nTo be eligible for the study, each participant must satisfy ALL of the following criteria:\n\n1. Age 18-50 years, inclusive.\n2. Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge.\n3. Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., complete Diary Cards, return for follow-up visits).\n4. Written informed consent obtained from the participant.\n5. If a cis woman and\u002For gender divergent person is at risk of becoming pregnant has practiced adequate contraception for 28 days prior to challenge and has a negative pregnancy test on the day before B. pertussis challenge and has agreed to continue adequate contraception until 60 days after inoculation.\n\nRisk of pregnancy is defined as any individual assigned female at birth or with reproductive capacity who is sexually active with individuals with sperm-producing capabilities. Individuals who have received the following are considered to not have reproductive capacity:\n\n* Documented hysterectomy\n* Documented bilateral salpingectomy\n* Documented bilateral oophorectomy\n* Documented and current bilateral tubal ligation or occlusion\n* Credible self-reported history of diagnosed infertility\n* Hormone therapy (e.g., testosterone), provided it is administered consistently and medically assessed as sufficient to reduce pregnancy such that ovulation has ceased\n* Any other condition, as determined by the Principal Investigator, that would render an individual incapable of becoming pregnant\n\nAdequate contraception is defined as a contraceptive method with a failure rate of \\\u003C1% per year when used consistently and correctly and, when applicable, in accordance with the product label. Examples include the following:\n\n* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal\n* Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable\n* Intra-uterine device (IUD) with or without hormonal release\n* Vasectomized partner, if this is the participant's sole partner and the partner has received a medical assessment of the surgical success\n* Credible self-reported history of abstinence for at least 28 days prior to challenge\n\nExclusion Criteria:\n\nParticipants with ANY of the following criteria at the time of screening will be excluded:\n\n1. Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder).\n2. Underlying cardiac and\u002For pulmonary disease including hypertension, angina, prior myocardial infarction, asthma, emphysema, chronic bronchitis, and pulmonary tuberculosis.\n3. Moderate or severe symptoms of health anxiety, anxiety, and mood symptoms. Self-reported current diagnosis of a major psychiatric illness, including a schizophrenia spectrum disorder, bipolar disorder, posttraumatic stress disorder, obsessive compulsive disorder, substance use, or eating disorder.\n4. QT prolongation on electrocardiogram (EKG).\n5. History of everyday smoking\u002Fvaping in the last 2 years and\u002For current smoking\u002Fvaping more than once per week.\n6. Pregnant (known before or established at the time of screening using a urine-based test) or breastfeeding.\n7. Immunocompromised (with HIV\u002FAIDS-positive or receiving immunosuppressive therapy involving steroids) or with any medical condition or medication that leads to a compromised immune system.\n8. Positive for hepatitis B or C by blood test.\n9. Vaccinated against pertussis within previous 5 years and\u002For \\>7 cumulative doses from infancy to date of screening.\n10. Reported history of laboratory-confirmed pertussis infection, including having been exposed to B. pertussis in a Controlled Human Infection Model\n11. Antibody titer to pertussis toxin \\>20 IU\u002FmL (2x the lower limit of quantification (LLOQ)).\n12. Detection of B. pertussis in nasal samples prior to challenge using culture isolation and\u002For PCR detection, or detection of other respiratory infection.\n13. Living or working with (any form of close contact) any of the at-risk\u002Fvulnerable groups who are not up to date on their vaccination, specifically children \\\u003C1 year of age, pregnant woman who have not yet received their maternal Tdap vaccine, immunocompromised individuals, adults \\>65 years of age who have not received a dose of Tdap vaccine within the past 10 years, or other at risk persons, as applicable, up to Day 57.\n\n    Note: Household members whose vaccination is not current will be offered or directed to a pertussis-containing vaccine, as recommended and funded by the Nova Scotia Department of Health and Wellness.\n14. Known allergy to macrolides including azithromycin or erythromycin, history of Clostridium difficile within last 2 months.\n15. Any contraindication to receiving azithromycin.\n16. Taking any systemic antibiotic currently or within the previous 2 weeks.\n17. Currently taking terfenadine, astemizole, theophylline, or cimetidine.\n18. Poor venous access, as defined by inability to obtain venous blood after 3 venipuncture attempts.\n19. Recent (within 6 months) nasal or sinus surgery, recent use of intranasal steroids (4 weeks), or diagnosis with nasal polyps.\n20. Receipt of any investigational drug or vaccine within 6 months prior to challenge. An investigational vaccine is defined as a vaccine that is still being tested in clinical trials or one that has not yet been authorized for use in Canada for administration by public vaccine programs.\n21. Receipt of any authorized vaccines within 2 weeks prior to challenge with B. pertussis in this study. (This is to avoid attributing any AEs from these vaccines to the B. pertussis challenge, which would skew the study results.)\n22. Previous moderate or severe respiratory infection that required hospitalization.\n23. Head trauma (e.g., fracture of the cribriform plate) within 1 year of screening.\n24. Any other finding that the Investigator considers will make the participant unsuitable for the study or unable to comply with the study requirements.\n25. Symptoms indicative of acute respiratory illness (such as fever, cough, difficulty breathing) identified during the physical examination done on Day -1 (check-in) or Study Day 1 before a participant is challenged.\n26. History of Bell's Palsy and\u002For facial paralysis.\n27. Receipt of facial cosmetic filler in the past 3 months.","18 Years","50 Years",{"count":52,"type":21},60,[24],"The overall goal of this study is to establish a PRN-deficient pertussis Controlled Human Infection Model (CHIM) that represents currently circulating isolates, in the context of a North American exposure (vaccination and infection) pedigree.",[27],[57,58,59,60,61,62,63],"Bordetella pertussis","Pertussis","Whooping cough","Controlled human infection model","Human challenge","Phase 1 clinical trial","Immune response","RECRUITING","2025-11-27",{"date":67,"type":34},"2025-12-04",{"date":69,"type":34},"2025-11-24",{"date":71,"type":21},"2027-04-30",{"name":73,"class":74},"Dalhousie University","OTHER",1]