[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"U.S. Army Medical Research and Development Command\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":156},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,67,84,112,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100531842","phase-1-evaluation-of-safety-and-immunogenicity-of-ad26mos4hiv-and-ch505-tf-chtrimer-combination-in-healthy-adults-100531842",false,"NCT06205056","Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults","Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults","RV591","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for participation:\n\n1. Male or female, aged 18 to 50 years, inclusive, at the time of enrollment\n2. Willing and able to read, sign, and date the informed consent form\n3. Demonstrates an understanding of the study with a passing score (90% or greater) on the TOU by the third attempt, before study-related procedures are performed\n4. Willing and able to comply with study requirements and be available to attend visits for the duration of study participation\n5. Must have the means to be contacted by telephone for the duration of study participation\n6. Willing to have photo or fingerprint taken for identification purposes\n7. At low risk for HIV acquisition per investigator assessment\n8. Agrees to refrain from donating blood or plasma outside of this study for at least the duration of study participation\n9. Healthy based on the physician investigator's clinical judgment after review of past medical history, medication use, vital signs, and an abbreviated physical examination\n\n   Note: Good health is defined by the absence of any medical condition described in the exclusion criteria in a participant with a normal abbreviated physical exam and vital signs. If the participant has a preexisting chronic condition not listed in the exclusion criteria, the condition cannot meet any of the following criteria:\n   1. first diagnosed within the 12 weeks prior to screening; or\n   2. worsening in terms of clinical outcome in the 24 weeks prior to screening; or\n   3. involves the need for medication that may pose a risk to the participant's safety or impede assessment of adverse events or immunogenicity if they participate in the study.\n\n   Note: Vital signs must be normal by Adverse Event Grading Scales, local normal ranges, or determined to be a normal variant by the physician investigator.\n\n   Note: An abbreviated physical exam differs from a complete exam in that it does not include a genitourinary and rectal exam.\n10. Laboratory criteria within 45 days prior to enrollment:\n\n    1. Hemoglobin ≥11.0 g\u002FdL for females; ≥12.5 g\u002FdL for males\n    2. White blood cells (WBC) range: 3,500-9,000 cells\u002Fmm\\^3\n    3. Platelets between 150,000 - 450,000 cells\u002FµL\n    4. Normal liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤1.25x upper limit of normal\n    5. Serum creatinine ≤1.25x upper limit of normal\n    6. Urinalysis: blood and protein less than 1+ and negative glucose\n    7. Negative HIV serology Note: HIV serology testing will be done via enzyme immunoassay with confirmatory testing of reactive results through a repeat enzyme immunoassay followed by an antibody differentiation immunoassay. After the repeat enzyme immunoassay, if an antibody differentiation immunoassay cannot be done for any reason, then confirmatory testing will be done via Western Blot. HIV rapid testing will not be performed in this study.\n    8. Negative hepatitis B surface antigen (HbsAg)\n    9. Negative hepatitis C serology or negative hepatitis C RNA (viral load) if antibodies are detected Note: Each laboratory screening test that is out of acceptable range can be repeated one time during the screening window if there is a possible alternative explanation for the out of range value or if the out of range value is due to a temporary condition that resolves within the screening visit window. A second screening visit may be conducted outside of the initial screening visit window for volunteers who meet certain criteria if study enrollment and\u002For participant replacement is ongoing.\n11. Biological Male-Specific Criteria:\n\n    1. Must agree to refrain from donating sperm from screening until at least 12 weeks after the last study injection\n    2. Must agree to consistently use a method of contraception from screening until at least 12 weeks after the last study injection\n12. Biological Female-Specific Criteria:\n\n    1. Not pregnant within 12 weeks prior to screening, not pregnant or breastfeeding at screening, and not planning to become pregnant or breastfeed at any time from screening until 12 weeks after the last study injection\n    2. Must have a negative human chorionic gonadotropin (β-HCG) pregnancy test (urine) at screening and at timepoints throughout the study, if of childbearing potential\n    3. Must agree to consistently practice a highly effective method of contraception at least 45 days prior to enrollment and for 12 weeks after the final injection, if of childbearing potential\n\nExclusion Criteria:\n\nVolunteers will be excluded if any of the following apply:\n\n1. Body mass index (BMI) \\\u003C18.0 kg\u002Fm\\^2 and \\>35.1 kg\u002Fm\\^2\n2. Has a condition which affects immune function, including but not limited to:\n\n   1. Known or suspected congenital or acquired immunodeficiency\n   2. Diabetes mellitus type 1 or type 2 (including cases controlled with diet alone) Note: A history of isolated gestational diabetes is not an exclusion criterion.\n   3. Thyroid disease\n   4. Asplenia, defined as any condition resulting in the absence of a functional spleen\n   5. Conditions and diagnoses defined as potential immune-mediated medical conditions\n3. Has a history of other chronic or clinically significant diseases or medical conditions that in the opinion of the investigator would jeopardize the safety or rights of the participant Note: Includes but is not limited to sickle cell anemia, chronic hepatitis or cirrhosis, chronic urticaria, chronic cardiac disease, hypertension not controlled by medication, severe asthma, chronic pulmonary disease, renal failure, and lymphatic filariasis.\n4. Has a history of malignancy other than squamous cell or basal cell skin cancer, unless there has been definitive surgical and\u002For medical treatment that is considered to have achieved a cure\n5. Had major surgery (per the physician investigator's judgment) within the 28 days prior to screening or has plans to have major surgery during the study\n6. Has a personal or family history of a bleeding disorder, such as factor deficiency, coagulopathy, or platelet disorder requiring special precautions\n7. Has a personal or family history of a blood clotting disorder, such as thrombosis with thrombocytopenia syndrome (TTS), heparin-induced thrombocytopenia and thrombosis (HITT), deep vein thrombosis, pulmonary embolism, acute myocardial infarction, and stroke\n8. Has a condition known to increase risk of blood clotting, including but not limited to autoimmune disease, connective tissue and other inflammatory conditions, immobility, recent infection, and recent head trauma including cerebrovascular accidents (stroke)\n9. Hepatitis B surface antigen positive at any time in the past\n10. Untreated syphilis infection as confirmed by RPR or a similar quantitative nontreponemal test such as VDRL\n11. Prior receipt or plans to receive any of the following:\n\n    1. Chronic use of therapies that may modify immune response, such as high dose inhaled and sprayed corticosteroids (\\>440 µg\u002Ftwice daily doses of inhaled fluticasone equivalent) and systemic corticosteroids (\\>20 mg\u002Fday doses of prednisone equivalent for periods exceeding 10 days) within 14 days prior to enrollment or at any time during participation in this study Note: The following exceptions are permitted and will not exclude study participation: use of stable low\u002Fmedium doses (\\\u003C440 µg\u002Ftwice daily doses of inhaled fluticasone equivalent) of inhaled and sprayed corticosteroids, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on the physician investigator's clinical judgment) at least 14 days prior to enrollment in this study. Includes other medications, which, in the opinion of the physician investigator(s), will impact the participant's immune response.\n    2. Blood products within 120 days prior to enrollment or at any time during participation in this study\n    3. Immunoglobulins within 90 days prior to enrollment or at any time during participation in this study\n    4. Therapy for active tuberculosis within 90 days prior to enrollment, unless the therapy is considered to have achieved a cure, or at any time during participation in this study\n    5. Licensed or authorized vaccine from 30 days prior to enrollment until 42 days (6 weeks) after the last study injection Note: Participants may receive inactivated seasonal influenza vaccine or COVID-19 vaccine during their participation in this study but not within 14 days prior or 6 weeks after each study injection\n    6. Any investigational study products for conditions other than HIV within 90 days prior to enrollment or at any time during participation in this study\n    7. An investigational HIV vaccine or HIV antibody at any time prior to or during participation in this study\n    8. Medications that increase the risk of bleeding (warfarin, clopidogrel, ticagrelor, dabigatran, rivaroxaban, apixaban, heparin and other heparinoids) or blood clots (heparin in participants who have a prior history of heparin-induced coagulopathy) within 30 days prior to enrollment or at any time during participation in this study. \\[Note: Volunteers determined to be ineligible at screening due to receipt of the above listed substances may be re-screened once the applicable window of receipt has expired if study enrollment and\u002For participant replacement is ongoing\\].\n12. Has a known allergy or history of anaphylaxis or other serious reaction to a vaccine, vaccine component, or latex\n13. Current or planned participation in another study requiring blood draws or exposure to investigational or non-investigational vaccine\u002Fproduct (pharmaceutical or device) throughout the study period\n14. Has tattoos, scars, or other marks that would, in the opinion of the physician investigator, interfere with the assessment of the injection sites\n15. Current or history of substance abuse within 12 months prior to enrollment that, in the physician investigator's opinion, could interfere with reliable participation\n16. In the physician investigator's opinion, is unable to communicate reliably, is unlikely to adhere to study requirements, or has a condition that would limit completion of the study\n17. Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the participant or potentially impairs immune response or threatens conduct of the study according to protocol\n18. Study site employee\n\nFinal evaluation of eligibility will be based on the medical judgment of the physician investigator.",true,"ALL","18 Years","50 Years",{"count":22,"type":23},78,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV",[29],"Human Immunodeficiency Virus","RECRUITING","2025-10-01",{"date":33,"type":34},"2025-10-07","ACTUAL",{"date":36,"type":34},"2024-01-30",{"date":38,"type":23},"2026-06",{"name":40,"class":41},"U.S. Army Medical Research and Development Command","FED",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":24,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100281593","transcranial-electrical-stimulation-tes-at-slow-oscillation-so-frequency-during-nrem-sleep-100281593","NCT02945501","Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep","Transcranial Electrical Stimulation at Slow Oscillation Frequency During NREM Sleep: An Assessment of Effects on the Restorative Properties of Sleep","Inclusion Criteria:\n\n* Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)\n* Must demonstrate adequate comprehension of the protocol, by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given one opportunity to retest after a review of protocol information. Individuals who fail the comprehension assessment for the second time will be disqualified.\n\nExclusion Criteria:\n\n* Self-reported habitual nightly sleep amounts outside the target range of 6 - 9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average) (Post-consent Checklist)\n* Self-reported nighttime lights-out times earlier than 2100 hours on average during weeknights (Sunday through Thursday) or later than 2300. (Post-consent Checklist)\n* Self-reported morning wake-up times later than 0800 on average during weekdays (Monday through Friday) (Post-consent Checklist)\n* Self-reported habitual napping (\\> 1 time a week in conjunction with normal sleep habits) (Post-consent Checklist)\n* A rating of 6 or below on question 2 or 3 of the Nonrestorative Sleep Scale, indicating the subject experiences relatively non-refreshing sleep\n* An average time to sleep onset of greater than 20 minutes as indicated on the Post-consent Checklist\n* Self-reported caffeine use in excess of 400 mg (e.g., approximately 8 caffeinated sodas or 4 12-oz cups of coffee) per day on average (Post-consent Checklist; document provides exclusionary limits for various caffeinated products).\n* Score of lower than 31 or higher than 69 on the Morningness-Eveningness Questionnaire (MEQ form)\n* Score of 14 or above on the Beck Inventory Form (BDI form)\n* Score of 41 or above on the Self-Evaluation Questionnaire\n* History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction) (Medical History and Examination Form)\n* History of neurologic disorder (to include, but not limited to epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, MS, narcolepsy or other sleep disorders) (Medical History and Examination form; sleep items on Post-Consent Checklist)\n* Underlying pulmonary disease requiring daily inhaler use (Medical History and Examination form)\n* Kidney disease or kidney abnormalities (Medical History and Examination form, laboratory results)\n* Liver disease or liver abnormalities (Medical History and Examination form, laboratory results)\n* Self-reported history of psychiatric disorder requiring hospitalization or psychiatric product within the last 2 years or for more than 3 months at one time. (Medical History and Examination form)\n* Self-reported or suspected regular nicotine use or addiction, defined as more than 1 cigarette or equivalent per week, within the last 1 year (Medical History and Examination form)\n* Self-reported or suspected heavy alcohol use; minimum limit to define heavy alcohol use is 14 drinks per week or as determined by the examining appropriately licensed study investigator (Medical History and Examination form)\n* Self-reported or suspected use of products or drugs that cannot be safely discontinued during in-laboratory phases, to be determined on a case-by-case basis by the examining appropriately licensed study investigator (Medical History and Examination form)\n* Self-reported or suspected current use of other illicit drugs, to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana (Medical History and Examination form)\n* Positive urine pregnancy result\n* Resting blood pressure above 140\u002F90 or resting pulse \\> 110 (Medical History and Examination form). Note that if a repeat measurement is within range then the volunteer will not be excluded.\n* BMI ≥ 30 (Obese Class I or greater) (Medical History and Examination form)\n* Clinically significant values (as determined by the appropriately licensed study investigator reviewing the study) for any hematology or chemistry parameter. The appropriately licensed study investigator reviewing the laboratory values may opt to repeat any clinically significant tests and include volunteers whose repeat test values are not clinically significant.\n* Positive urine nicotine\u002Fcotinine result during screening visit (NicCheck™ I test strip results)\n* Positive urine drug result during screening visit\n* Any use of sleep aids during the 1 year prior to screening\n* Inability to read and sign consent\n* Lack of access to a quiet, dark environment conducive to sleep from 2100 until 0700 during a seven night period at the beginning of the study\n* Participation in any ongoing clinical trials.\n* The preceding exclusionary criteria are known to alter sleep (e.g., epilepsy; some neurological disorders), substantially increase inter-subject variability, and\u002For the disease or condition puts the subject outside the range of what is considered healthy. The PI also maintains the prerogative to disqualify a volunteer if it is deemed that the volunteer's participation would be unsafe for the volunteer or staff or would be disruptive to study conduct or their inclusion could compromise data integrity.\n* Volunteers meeting the Beck cut-off (a score of at least 14) and who carry health insurance will be instructed to call their health insurance Mental Health \u002F Substance Abuse referral number.\n* Volunteers meeting the first cut-off (score of at least 14 who are not insured will be provided with a community mental health referral contact specific to their county of residence.\n* The review of the medical history with the volunteer and the physical examination itself will be performed by an appropriately licensed study investigator. Results of screening urine and blood tests will be reviewed by an appropriately licensed study investigator. The Post-consent Checklist will be administered by a trained research technician and reviewed by the study principal investigator or an appropriately licensed study investigator. If an appropriately licensed study investigator deems it medically advisable, the investigator will share abnormal results with the volunteer, who will be referred to his\u002Fher personal physician for follow-up.\n* A volunteer who has been cleared for participation may participate in a session if the first day of the session is within 90 days of the screening date. If the first day of the study session is 91 or more days since the volunteer has been screened, the volunteer must re-screen to ensure there has not been a change in eligibility status.","39 Years",{"count":52,"type":23},40,[54],"NA","The purpose of this study is to determine if the enhancement of electroencephalographic (EEG) slow-wave activity using transcranial electrical stimulation (TES) at Slow Oscillation (SO) frequency, during a restricted period of nocturnal sleep, enhances the restorative properties of that period of sleep and improves performance during a subsequent period of sleep deprivation.",[57,58],"Sleep Deprivation","Mental Competency","2025-06-10",{"date":61,"type":34},"2025-06-13",{"date":63,"type":34},"2016-10-27",{"date":65,"type":23},"2027-12",{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":83,"locationsCount":4},"100215367","tecovirimat-st-246-treatment-for-orthopox-virus-exposure-100215367","NCT02080767","Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure","Clinical Protocol to Treat Individuals With Tecovirimat (ST-246) After Exposure to Orthopox Viruses","Inclusion Criteria:\n\n* DoD-affiliated personnel (including US civilian employees, contractors and other US personnel and dependents, as well as allied military forces and local nationals) of any age, not breastfeeding\n* Has been exposed to or infected with orthopox viruses (ie, variola (smallpox), vaccinia, monkeypox, or cowpox) OR Has developed serious complications from vaccinia vaccination (eg, eczema vaccinatum, progressive vaccinia, generalized vaccinia that is severe or persistent, and select cases of inadvertent inoculation due to severe pain related to mucosal involvement, ocular involvement) resulting from vaccination, secondary transmission, or other exposure\n* Is available for clinical follow-up for duration of the treatment and follow-up period\n* Must be able to swallow capsules\n\nExclusion Criteria:\n\n* Has hypersensitivity to tecovirimat\n* Unable or unwilling to cooperate with the requirements of the treatment protocol\n* Breast-feeding patients. Note that breast-feeding females will be counseled that tecovirimat has not been studied in breast-feeding women and may opt to cease breast-feeding for the duration of the treatment and at least 30 days after the last dose of drug and thus be eligible for enrollment. Women who choose to continue breast-feeding will not be enrolled in this treatment protocol.","EXPANDED_ACCESS","The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.",[77,78],"Smallpox","Monkeypox","AVAILABLE","2025-03-05",{"date":82,"type":34},"2025-03-06",{"name":40,"class":41},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100376393","an-evaluation-of-two-ptsd-assessments-in-an-active-duty-and-military-veteran-sample-100376393","NCT04180930","An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample","Psychometric Evaluation of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) in an Active Duty and Military Veteran Sample","Inclusion Criteria:\n\n* Male or female active duty personnel or military veterans, 18 years of age or older\n* Competent to give informed consent\n* Have experienced any Criterion A qualifying traumatic event as defined by the Life Events Checklist for DSM-5 (LEC-5)\n* Score a 3 or above on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)\n\nExclusion Criteria:\n\n* Current suicidal or homicidal ideation with a plan, and substance use disorder requiring detoxification currently or in the past month as assessed using the SCID and Suicidal Ideation\u002FHomicidal Ideation screening tool (SI\u002FHI screen)\n* Assessment using CAPS or PSSI in the previous 1 year\n* Currently receiving psychotherapy or counseling for PTSD\n* Moderate to sever cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)\n* Meet criteria for unmedicated Bipolar I, Bipolar II, Schizophrenia, or other psychotic disorders in the last month",{"count":92,"type":23},950,"OBSERVATIONAL","Given the high prevalence of post-traumatic stress disorder (PTSD) in veterans and active duty military, the focus of this research study is to test the reliability of two new PTSD assessments, the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) and compare the results between the two new assessments and the previous \"gold standard\", the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV). Biomarkers believed to be related to PTSD (e.g., biofluid biomarkers, cognitive and physiological markers, and neural activity as measured by EEG) will be collected to inform targeted interventions in specific groups of patients and other large-scale biomarker discovery efforts in the field. Participants will be 950 male and female active duty military and veterans ages 18 or older who have been exposed to at least one traumatic event.",[96],"Stress Disorders, Post-Traumatic",[98,99,100,101,102],"Assessment","Post-Traumatic Stress Disorder","PTSD","Veterans","Military","2025-01-22",{"date":105,"type":34},"2025-01-23",{"date":107,"type":34},"2019-04-15",{"date":109,"type":23},"2025-06-30",{"name":40,"class":41},3,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":24,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":42},"100332524","phase-2-phase-2-safety-and-immunogenicity-study-of-rift-valley-fever-vaccine-100332524","NCT03609398","Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine","A Phase 2 Open Label Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated, Dried, TSI-GSD 200, Lot 7, Run 2, in Adult Subjects at Risk of Exposure to Rift Valley Fever Virus","RVF","Inclusion Criteria:\n\n* Be 18 to 65 years old at time of consent.\n* Have RVF plaque reduction neutralization 80% titers (PRNT80) \\\u003C1:10 for primary series.\n* Have RVF PRNT80 (plaque reduction neutralization 80% titer) \\\u003C1:40 for booster series.\n* If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccine administration. (Exception: documented hysterectomy or ≥3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).\n* Be considered at risk for exposure to RVF virus and who have submitted a Request for IND Vaccines for the RVF vaccine.\n* Sign and date the approved informed consent document and HIPAA Authorization.\n* Have in their charts:\n* medical history (including concomitant medications) within 60 days of planned first administration of vaccine\n* physical examination and laboratory tests within 1 year\n* previous chest radiograph results and electrocardiogram\n* Be medically cleared for participation by an investigator. (Examinations and\u002For tests may be repeated at the discretion of the PI.)\n* Be willing to return for all follow-up visits.\n* Agree to report any adverse events (AEs) that may or may not be associated with administration of the vaccine for at least 28 days after administration and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study.\n* Agree to defer blood donation for 1 year after receipt of the vaccine\n\nExclusion Criteria:\n\n* Have completed previous RVF vaccine study as a nonresponder (PRNT80 \\\u003C1:40).\n* Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).\n* Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.\n* Have confirmed HIV infection.\n* Have positive pregnancy test or be breastfeeding female.\n* Have any known allergies to components of the vaccine:\n* Fetal rhesus monkey lung cells\n* Formaldehyde\n* Neomycin sulfate\n* Streptomycin\n* Sodium bisulfite\n* Human serum albumin (HAS)\n* RVF virus (Entebbe strain)\n* Have administration of another vaccine or investigational product within 28 days of RVF vaccination.\n* Have any unresolved AE resulting from a previous immunization.\n* Have a medical condition that, in the judgment of the PI, would impact subject safety.","65 Years",{"count":122,"type":23},500,[124],"PHASE2","This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine",[127],"Rift Valley Fever","2021-02-10",{"date":130,"type":34},"2021-02-11",{"date":132,"type":34},"2018-10-04",{"date":134,"type":23},"2024-12",{"name":40,"class":41},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":120,"enrollmentInfo":144,"targetDuration":4,"studyType":24,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":155,"locationsCount":42},"100326531","phase-2-safety-and-immunogenicity-study-of-venezuelan-equine-encephalomyelitis-vee-vaccine-as-booster-vaccine-in-adults-100326531","NCT03531242","Safety and Immunogenicity Study of Venezuelan Equine Encephalomyelitis (VEE) Vaccine as Booster Vaccine in Adults","Phase 2 Open-Label Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, as Booster Vaccination in Adult Subjects at Risk of Exposure to VEE Virus","VEE","Inclusion Criteria:\n\n* Be 18 to 65 years old at time of consent\n* Have received VEE TC-83 vaccine\n* Have VEE plaque reduction neutralization 80% titers (PRNT80) \\\u003C1:20\n* If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccination administration. (Exception: documented hysterectomy or \\>3 years of menopause). The results must be negative. Females just agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).\n* Be considered at risk for exposure to VEE virus and who have submitted a Request for IND Vaccines for VDD vaccine.\n* Sign and date the approved informed consent document and HIPAA Authorization.\n* Have in their charts:\n* medical history (including concomitant medications) within 60 days of planned first administration of vaccine\n* physical examination and laboratory tests within 1 year\n* previous chest radiograph results and electrocardiogram\n* Be medically cleared for participation by an investigator (Examinations and\u002For tests may be repeated at the discretion of the PI).\n* Be willing to return for all follow-up visits.\n* Agree to report any adverse events (AEs) that may or may not be associated with administration of the vaccine for at least 28 days after administration and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study.\n* Agree to defer blood donation for 1 year after receipt of the vaccine.\n\nExclusion Criteria:\n\n* Have completed previous VEE C-84 vaccine study as a non-responder.\n* Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).\n* Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg, prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.\n* Have confirmed HIV infection.\n* Have positive pregnancy test or be a breastfeeding female.\n* Have any known allergies to components of the vaccine:\n* Neomycin sulfate\n* Streptomycin\n* VEE virus, inactivated\n* Formaldehyde\n* Eggs\n* Human serum albumin\n* Guinea pig heart cells\n* Sodium bisulfite\n* Have had a previous serious allergic reaction to guinea pigs or guinea pig products. (Subjects who have known allergies to guinea pigs but whose allergic reactions were not severe may still participate in the study but should be referred to an allergy specialist for assessment and recommendation prior to vaccination).\n* Have received or plan to receive another vaccine or investigational product within 28 days of VEE vaccination.\n* Have any unresolved AE resulting from a previous immunization.\n* Have a medical condition that, in the judgment of the PI, would impact subject safety.",{"count":122,"type":23},[124],"The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, C-84, TSI-GSD 205, Lot 7, Run 1, and collect data on the incidence of occupational VEE infection in vaccinated personnel.",[148],"Venezuelan Equine Encephalomyelitis","NOT_YET_RECRUITING",{"date":151,"type":34},"2021-02-16",{"date":153,"type":23},"2021-06",{"date":134,"type":23},{"name":40,"class":41},""]