[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Shenxin Biotechnology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":4},"100538178","phase-1-a-study-to-describe-the-safety-and-immunogenicity-of-a-respiratory-syncytial-virus-vaccine-in006-in-healthy-adults-100538178",false,"NCT06287450","A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Adult Participants","Key Inclusion Criteria:\n\n1. Healthy male or female participants aged ≥18 to 59 years of age (Part 1) or ≥ 60 to 79 years of age (Part 2).\n2. Body weight ≥ 50 kg for males and ≥ 45 kg for females and body mass index (BMI) in the range of 18.5 to 35 kg\u002Fm\\^2.\n3. For all women of childbearing potential (WOCBP) females must be non-pregnant and non-lactating and must use an appropriate contraceptive method from at least 30 days prior to study vaccination (an effective contraception) until at least 6 months after study vaccination. Women not of childbearing potential must be postmenopausal for ≥ 12 months.\n4. Male participants who are non-sterilized and sexually active must be willing to use an acceptable, effective contraceptive method from at least 30 days prior to study vaccination until at least 6 months after study vaccination.\n5. Able and willing to complete the study procedures during the entire study Follow-up period.\n6. Can understand the study procedures, voluntarily sign the informed consent form after informed consent, and be able to comply with the requirements of the clinical study protocol.\n\nKey Exclusion Criteria:\n\n1. Pregnant or lactating at Screening or prior to vaccination or planning to become pregnant (self or partner) at any time during the study, including the specified Follow-up period.\n2. Participants with a known (documented or self-reported) history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis.\n3. Participants with a known (documented or self-reported) history of heart disease (eg, heart failure, recent coronary artery disease, myocarditis, pericarditis, cardiomyopathy, or atrial fibrillation). Note: chronic stable coronary artery disease that is considered mild may be allowed at the discretion of the Investigator.\n4. Participants with uncontrolled hypertension (supine systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg at Screening). Results at Screening may be confirmed by single repeat at the discretion of the Investigator.\n5. Participants with a Screening 12-lead ECG following at least 5 minutes of supine rest demonstrating a Fridericia corrected QT (QTcF) interval \\> 450 msec (for males) or \\> 470 msec (for females) or a QRS interval ≥ 120 msec.\n6. Participants with clinically significant abnormalities that indicate or meet the definition of a Grade 1 or greater abnormality for Part 1, or a Grade 2 or greater abnormality for Part 2 as delineated in the FDA guidance \"Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials\".\n7. Participants with acute medical or febrile illness (body temperature \\> 38.0°C or 100.4°F) within one day prior to vaccination.\n8. History of severe hypersensitivity reactions, including anaphylaxis or other significant adverse reactions to any components of a mRNA vaccine or known components of IN006.\n9. Received any live attenuated vaccines ≤ 28 days prior to vaccination or plans to receive any licensed vaccines within 28 days before the study vaccination, with the exception of licensed inactivated influenza vaccine or non-replicating influenza vaccine which may be given ≥ 14 days prior to the first study vaccination.\n10. Received immunomodulatory, immunostimulatory, or immunosuppressant drugs including interferon and cytotoxic drugs within 90 days of Screening or planning to receive during the study.\n11. Received a previous vaccination with any licensed or investigational RSV vaccine prior to enrollment or planned to receive at any time throughout the duration of the study.\n12. Received immunoglobulin and\u002For any blood products within 120 days of vaccination.\n13. Use of systemic corticosteroids exceeding the equivalent of 10 mg\u002Fday of prednisone for ≥ 10 days within 30 days of Screening or planning to receive during the study.\n14. History of a known bleeding disorder that would, in the opinion of the Investigator, contraindicate intramuscular (IM) injection.\n15. History of congenital or acquired immunodeficiency including HIV or immunosuppressive disorder, asplenia, or recurrent severe infections.\n16. Known or suspected clinically significant or unstable significant hematologic (including clotting disorders), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and untreated seasonal allergies) that may interfere with the study evaluations or the participants ability to complete the study, in the opinion of the Investigator.\n17. History of, or current positive results for, any of the following serological tests: HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV Ab), or syphilis.\n18. Recent history of major surgical procedures within 90 days of Screening.\n19. Treatment with an investigational product within 30 days, or 5 half-lives (whichever is longer) preceding vaccination.\n20. Blood donation of approximately 500 mL or more within 60 days prior to vaccination.\n21. Any other reason to be excluded in the opinion of the Investigator.",true,"ALL","18 Years","79 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults.",[28],"Respiratory Syncytial Virus Infections",[30,31,32,33,34,35,36,37,38,39,40,41,42],"mRNA Vaccine","IN006","Respiratory syncytial virus","Viral Diseases","Messenger RNA","Innorna","Shenxin","Vaccines","Respiratory tract infections","Safety","Reactogenicity","Immunogenicity","RSV","NOT_YET_RECRUITING","2026-04-10",{"date":46,"type":47},"2026-04-13","ACTUAL",{"date":49,"type":22},"2026-12",{"date":51,"type":22},"2028-04",{"name":53,"class":54},"Shenzhen Shenxin Biotechnology Co., Ltd","INDUSTRY",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":16,"sex":17,"minAge":62,"maxAge":19,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100608764","phase-2-a-phase-2-study-to-describe-the-safety-reactogenicity-and-immunogenicity-of-herpes-zoster-in001-mrna-vaccine-in001-in-healthy-participants-100608764","NCT07205796","A Phase 2 Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants","A Phase 2, Randomized, Multicenter, Active-controlled, Double-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a 2-dose Regimen of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants 50 to 79 Years Old","Key Inclusion Criteria:\n\n1. Male or female adults, of any race or ethnicity, between 50 and 79 years of age, inclusive, at Screening.\n2. Male and female participants must have a body mass index between 18.5 and 34.9 kg\u002Fm\\^2, inclusive, at Screening, and body weight ≥ 50 kg for males and ≥ 45 kg for females.\n3. Participants must be able to freely provide documented informed consent prior to study procedures being performed.\n4. Participants must be in good general health as determined by comprehensive evaluation by Investigators at the time of enrollment.\n5. Participants with asymptomatic medical conditions that are not associated with end-organ damage may be include provided that they are being appropriately treated as per standard of care, are clinically stable, and are not receiving treatments what would be exclusionary in the opinion of the Investigator.\n6. Participants must be able and agree to comply with all study visits and procedures (including blood tests, diary completion, receipt of telephone calls from the site, willingness to be available for unscheduled clinic visits).\n7. Females of reproductive age will not be pregnant or lactating.\n8. Females of childbearing potential, who are sexually active and at risk for pregnancy with their partner(s), must have used appropriate method of contraception at least 30 days prior to enrollment and agree to use a highly effective method of contraception consistently and correctly from enrollment to Study Day 236 (6 months after second vaccination). The Investigator or designee, in consultation with the participant, will confirm that the participant has selected an appropriate method of contraception for the individual participant and his or her partner from the list of appropriate contraception methods and will confirm that the participant has been instructed in its consistent and correct use.\n9. Participants must be willing to refrain from blood donation throughout study participation.\n\nKey Exclusion Criteria:\n\n1. Participants with a known history of HZ.\n2. Participants with a known history of GBS, encephalomyelitis, or transverse myelitis.\n3. Participants with a known history of severe heart disease (i.e., heart failure, recent coronary artery disease, myocarditis, pericarditis, or cardiomyopathy).\n4. Participants with acute medical illness or febrile illness, including oral temperature ≥ 38.0°C (≥ 100.4°F) within 1 day prior to Screening. These individuals may be offered the opportunity to enter the study after the fever and\u002For acute illness has been resolved.\n5. Participants with any medical, neurological, or psychiatric condition that, in the opinion of the Investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.\n6. Participants with a known history of hypersensitivity reactions including anaphylaxis and urticaria, or other significant adverse reactions to IN001 or its excipients; or participants with a known history of severe allergic reaction (e.g., anaphylaxis) to any mRNA vaccine (e.g., COVID-19 mRNA vaccine, RSV mRNA vaccine), any component of SHINGRIX\\^TM, or after a previous dose of SHINGRIX\\^TM.\n7. Participants who have a positive pregnancy test at the screening visit or who intend to become pregnant during or breastfeed through Study Day 236 (6 months after second vaccination).\n8. Participants with uncontrolled hypertension (supine systolic blood pressure \\[BP\\] \\> 140 mmHg or supine average diastolic BP \\> 90 mmHg at Screening). Eligibility may be reassessed with a single repeat measurement at the Investigator's discretion, and the repeat value will be used for determination.\n9. Participants with a history of significant hematologic abnormalities or history of thrombosis with thrombocytopenia syndrome.\n10. Participants with hematology and\u002For clinical chemistry laboratory result(s) that meet the definition of a Grade ≥ 2 abnormality as delineated in the FDA guidance. However, if the institutional normal reference ranges differ from those defined by the region or site, exceptions may be considered on a case-by-case basis with the agreement of the Investigator and the Sponsor.\n11. Participants with a history of congenital or acquired immunodeficiency.\n12. Participants with an immunosuppressive or immunodeficient state, asplenia, or recurrent severe infections.\n13. Participants with a known history of chronic infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis.\n14. Positive HBV and HCV panel and\u002For positive HIV test. Participants whose results are compatible with prior immunization (indicating evidence of protection) may be included at the discretion of the Investigator that take into account factors such as the timing and effectiveness of the previous immunization.\n15. Participants with positive syphilis test.\n16. Participants with chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial participation or interpretation of study results.\n17. Participants with a known history of vaccination against varicella or HZ.\n18. Participants who have received immunoglobulins and\u002For any blood or blood products within 4 months before the first study vaccination or who plan to receive such products at any time during the study.\n19. Participants who have received immunomodulatory, immunostimulatory, or immunosuppressant drugs including interferon and cytotoxic drugs within 3 months of Screening (or 5 half-lives, whichever is longer) or who plan to receive them across the duration of the study.\n20. Participants requiring systemic corticosteroids exceeding 10 mg\u002Fday of prednisone equivalent for ≥ 10 days within 30 days of Screening. The use of topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted.\n21. Participants who have received or plan to receive any licensed vaccine ≤ 28 days prior to the first vaccination (Day 0) or who plan to receive a licensed vaccine ≤ 28 days after the first study vaccination or ≤ 28 days before or after the second study vaccination. The only exception is licensed inactivated influenza vaccine or non-replicating influenza vaccine, which may be given ≥ 14 days before or ≥ 28 days after receipt the first or second study vaccination.\n22. Participants receiving treatment with another investigational drug, biological agent, or device ≤ 28 days of Screening, or 5 half-lives of the investigational drug, whichever is longer; or currently enrolled in or plans to participate in another clinical trial with an investigational agent during the study period (including the follow-up period of the study).\n23. Participants with history of drug abuse within 1 year prior to Screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to Screening.\n24. History of alcohol abuse within 1 year prior to Screening or regular use of alcohol within 6 months prior to Screening that exceeds 10 units for women or 15 units for men of alcohol per week.\n25. Positive alcohol breath test result or positive urine drug screen (UDS) caused by misuse of soft drugs, hard drugs or abuse of any other concomitant medications at Screening and\u002For on Study Day 0.\n26. Participants who are Investigator site staff members, employees of the Sponsor or the clinical research organization directly involved in the conduct of the study, or site staff members otherwise supervised by the Investigator or immediate family members of any of the previously mentioned individuals.\n27. Participants with a demonstrated inability to comply with the study procedures.\n28. Anything that the Investigator considers would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.","50 Years",{"count":64,"type":22},480,[66],"PHASE2","The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of 3 dose levels of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 79 years of age.",[69],"Herpes Zoster",[71,30,72,73,74,33,75,34,76,77,39,40,41,35,36,78,79,80,81,82,83],"IN001","Vaccine","Varicella-zoster Virus","VZV","Shingles","Herpes Zoster (HZ)","Skin Diseases, Infectious","Herpesviridae Infections","DNA Virus Infections","Infections","Varicella Zoster Virus Infection","Skin Diseases, Viral","Skin Diseases","2025-10-04",{"date":86,"type":47},"2025-10-07",{"date":88,"type":22},"2026-05-01",{"date":90,"type":22},"2027-12-30",{"name":53,"class":54},""]