[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"International AIDS Vaccine Initiative\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":138},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,68,93,117],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100636392","phase-1-a-clinical-study-to-investigate-the-safety-and-immunogenicity-of-rvsvg-sudv-gp-a-sudan-virus-sudv-vaccine-for-the-prevention-of-sudv-disease-in-adults-in-good-general-health-100636392",false,"NCT07565090","A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health","A Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-SUDV-GP Vaccine in Adults in Good General Health","Inclusion Criteria\n\n1. Adults in good general health\n2. Participants who are 18 to 50 years of age\n3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study\n4. In the opinion of the PI, participant understands risks and written informed consent will be obtained before any study-related procedures are performed\n5. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results\n6. All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following IP administration\n7. All individuals of childbearing potential engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccine\u002Fplacebo\n8. All individuals of childbearing potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA)\n9. All participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study\n\nExclusion Criteria\n\n1. Any clinically relevant abnormality on history or examination including:\n\n   history of immunodeficiency or autoimmune disease history of splenectomy history of malignancy in the past 5 years use of corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the Investigator within the previous 6 months body mass index (BMI) ≥ 35.0 kg\u002Fm2\n2. Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study\n3. Individuals who are pregnant or breastfeeding\n4. Bleeding disorder that was diagnosed by a physician\n5. Infectious disease: Confirmed HIV-1 or HIV-2 infection, chronic active hepatitis B infection, current hepatitis C infection, active syphilis, or medically diagnosed long COVID 19 Syndrome. Also excluded are participants with active, serious infections requiring parenteral antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment.\n6. Any abnormal laboratory parameters at screening per protocol.\n7. Receipt of live attenuated influenza vaccine within the previous 14 days, any other live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with IP; or receipt of non-live attenuated vaccine within the previous 14 days or planned receipt within 14 days after vaccination with IP, including COVID-19 vaccines\n8. Receipt of blood transfusion or blood-derived products within the previous 3 months\n9. Prior potential exposure to Marburg Virus, or a medical history of hemorrhagic fever\n10. Prior receipt of any VSV-vectored vaccine, any Marburg vaccine, or any vaccine containing a filovirus component. Prior receipt of monoclonal or polyclonal antibodies directed against Marburg or other filovirus in the past 12 months\n11. Current participation in another clinical trial, within 3 months prior to enrollment.\n12. History of severe local or systemic reactogenicity to vaccines, or severe allergy to food or medications, and\u002For allergy to any component of this vaccine.\n13. Neuropsychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol\n14. Current or planned occupational (medical care, childcare) or household contact (residing in the same household) from screening through 3 months after IP administration with any individual at increased risk from exposure to a live viral vaccine including infants ≤ 1 year of age, adults\n\n    ≥75 years of age, or immunocompromised individuals.\n15. In the opinion of the PI, it is not in the best interest of the participant to participate in the trial\n16. A history of long-term treatment (≥ 4 weeks) for arthritis\n17. Participants currently experiencing a rash or who have a history of severe, chronic, or frequent rash will be excluded.",true,"ALL","18 Years","50 Years",{"count":21,"type":22},112,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health.",[28],"Sudan Virus Disease",[30,31,32,33,34],"Sudan virus","Infections","Virus diseases","Hemorrhagic fever","Ebola","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2026-05-08",{"date":43,"type":22},"2027-04",{"name":45,"class":46},"International AIDS Vaccine Initiative","NETWORK",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100625683","phase-1-a-phase-1-randomized-observer-blind-placebo-controlled-dose-escalation-clinical-trial-to-evaluate-the-safety-and-immunogenicity-of-rvsvg-marv-gp-vaccine-in-adults-in-good-general-health-100625683","NCT07425821","A Phase 1 Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health","Inclusion Criteria\n\n1. Adults in good general health\n2. Participants who are 18 to 50 years of age\n3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study\n4. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results\n5. All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following IP administration\n6. All individuals of childbearing potential engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccine\u002Fplacebo\n7. All individuals of childbearing potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA)\n8. All participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study\n\nExclusion Criteria\n\n1. Any clinically relevant abnormality on history or examination including:\n\n   history of immunodeficiency or autoimmune disease history of splenectomy history of malignancy in the past 5 years use of corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the Investigator within the previous 6 months body mass index (BMI) ≥ 35.0 kg\u002Fm2\n2. Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study\n3. Individuals who are pregnant or breastfeeding\n4. Bleeding disorder that was diagnosed by a physician\n5. Infectious disease: Confirmed HIV-1 or HIV-2 infection, chronic active hepatitis B infection, current hepatitis C infection, active syphilis, or medically diagnosed long COVID 19 Syndrome. Also excluded are participants with active, serious infections requiring parenteral antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment.\n6. Any abnormal laboratory parameters at screening per protocol.\n7. Receipt of live attenuated influenza vaccine within the previous 14 days, any other live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with IP; or receipt of non-live attenuated vaccine within the previous 14 days or planned receipt within 14 days after vaccination with IP, including COVID-19 vaccines\n8. Receipt of blood transfusion or blood-derived products within the previous 3 months\n9. Prior potential exposure to Marburg Virus, or a medical history of hemorrhagic fever\n10. Prior receipt of any VSV-vectored vaccine, any Marburg vaccine, or any vaccine containing a filovirus component. Prior receipt of monoclonal or polyclonal antibodies directed against Marburg or other filovirus in the past 12 months\n11. Current participation in another clinical trial, within 3 months prior to enrollment.\n12. History of severe local or systemic reactogenicity to vaccines, or severe allergy to food or medications, and\u002For allergy to any component of this vaccine.\n13. Neuropsychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol\n14. Current or planned occupational (medical care, childcare) or household contact (residing in the same household) from screening through 3 months after IP administration with any individual at increased risk from exposure to a live viral vaccine including infants ≤ 1 year of age, adults ≥75 years of age, or immunocompromised individuals.\n15. In the opinion of the PI, it is not in the best interest of the participant to participate in the trial\n16. A history of long-term treatment (≥ 4 weeks) for arthritis\n17. Participants currently experiencing a rash or who have a history of severe, chronic, or frequent rash will be excluded.",{"count":21,"type":22},[25],"A Phase 1 Randomized, Observer Blind, Placebo-controlled, Dose-escalation and dose expansion Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health",[58],"Marburg Virus Disease","2026-04-10",{"date":61,"type":39},"2026-04-15",{"date":63,"type":39},"2026-03-27",{"date":65,"type":22},"2028-07",{"name":45,"class":46},2,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":16,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100537052","phase-2-a-study-to-evaluate-the-efficacy-safety-and-immunogenicity-of-mtbvac-in-adolescents-and-adults-living-in-a-tb-endemic-region-100537052","NCT06272812","A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.","A Phase 2b, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine, MTBVAC, Against TB Disease in Adolescents and Adults Aged 14-45 Years, Living in a TB Endemic Region.","Inclusion Criteria:\n\n1. Is male or female aged 14 through 45 years on Study Day 1.\n2. Has completed the written (or thumb printed and witnessed) informed consent process (participants older than 18 years) or has completed the written parental consent and participant assent process (participants younger than 18 years) before any study-related procedures were performed.\n3. Participants who, in the opinion of the investigatory, can and will comply with the requirements of the protocol (e.g., to stay in contact with the Clinical Research Centre (CRC), return for follow-up visits)\n4. Has general good health as confirmed by medical history and physical examination.\n5. All participants born female who are engaging in sexual activity that could lead to pregnancy must commit to use an acceptable method of contraception from 21 days prior to Study Day 1 and for the 2 months after vaccination. Acceptable contraception includes:\n\n   1. Condoms (male or female) with or without spermicide\n   2. Diaphragm or cervical cap with spermicide\n   3. Intrauterine device\n   4. Hormonal contraception (combined estrogen and progestogen, or progestogen-only), including contraceptive implant or injectable\n   5. Successful vasectomy in the male partner, considered successful if a woman reports that a male partner has:\n\n      documentation of azoospermia by microscopy (1 year ago) or a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy\n   6. Not of reproductive potential, such as having undergone hysterectomy, bilateral oophorectomy or tubal ligation, postmenopausal (any age and amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \\> 40 IU\u002FL), surgically sterile.\n   7. Sexual abstinence. All participants born female who are not heterosexually active at screening must agree to utilize an acceptable method of contraception if they become heterosexually active as outlined above.\n6. All male participants should agree to use barrier contraception with their female partners for at least 2 weeks after vaccination.\n7. Has not shared the same enclosed living space with someone diagnosed with TB for one or more nights or for frequent or extended daytime periods during the 6 months prior to Study Day 1.\n8. HIV negative at screening.\n9. Negative clinical screening questionnaire and Xpert MTB\u002FRIF negative sputum sample for pulmonary TB disease at screening.\n\nExclusion Criteria:\n\n1. Acute illness and\u002For axillary temperature ≥37.5°C on Study Day 1.\n2. Current suspicion or evidence (including but not limited to sputum Xpert MTB\u002FRIF positive) of active TB disease at any CRC. An attempt must be made to obtain sputum from each participant; persons who are sputum unproductive will be assumed to be Xpert MTB\u002FRIF negative.\n3. History of previous TB disease and\u002For treatment for TB disease.\n4. History of TB preventative therapy, not including BCG vaccination.\n5. Received any investigational drug or investigational vaccine within 42 days before Study Day 1, or planned use during the study period.\n6. Planned administration\u002Fadministration of a licensed vaccine not foreseen by the study protocol in the period starting 28 days before Study Day 1 and ending 28 days after vaccine administration.\n7. Prior receipt of any investigational TB vaccine candidate before Study Day 1. Note: receipt of placebo in a previous TB vaccine trial will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval.\n8. Chronic administration of immunosuppressive medication within 42 days before Study Day 1 (inhaled and topical corticosteroids are permitted).\n9. Any confirmed or suspected immunosuppressive, immunodeficient, or autoimmune condition based on medical history and physical examination (no laboratory testing required).\n10. Concurrent, or planned participation in any other investigational study during the study period. (Concurrent participation in an observational trial not requiring blood or tissue sample collection is not an exclusion.)\n11. Received immunoglobulin or blood products within 42 days before Study Day 1, or planned administration during the study period.\n12. History or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.\n13. Pregnant or lactating\u002Fnursing female, or positive urine pregnancy test during screening or pre-vaccination on Study Day 1.\n14. Indeterminate IGRA test result at screening.\n15. Any current, or history of, medication use or medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, might compromise the safety of the participant or make it unlikely that the participant will comply with the protocol.","14 Years","45 Years",{"count":78,"type":22},5500,[80],"PHASE2","A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in adolescents and adults aged 14-45 years, living in a TB endemic region.",[83],"Tuberculosis (TB)","2026-03-26",{"date":86,"type":39},"2026-03-31",{"date":88,"type":39},"2025-02-19",{"date":90,"type":22},"2028-03-31",{"name":45,"class":46},16,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":47},"100563509","phase-1-a-trial-of-a-gorilla-adenovirus-vectored-networked-epitopes-vaccine-administered-to-healthy-adults-living-without-and-with-hiv-100563509","NCT06617091","A Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without and With HIV.","A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without HIV and Living With HIV, in Southern Africa","IAVI C114","Inclusion Criteria:\n\n1. At least 18 years of age on the day of screening and has not reached his or her 51st birthday on the day of signing the Informed Consent Document.\n2. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.\n3. In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and\u002For risks linked to administration of the investigational product; written informed consent will be obtained from the participant before any study-related procedures are performed.\n4. All sexually active female participants capable of becoming pregnant must commit to use an effective method of contraception from 21 days prior to receiving the IP until 4 months following the last IP administration, including:\n\n   1. Intrauterine device, or contraceptive implant\n   2. Hormonal contraception\n   3. Successful vasectomy in the male partner (considered successful if a woman reports that a male partner has \\[1\\] documentation of azoospermia by microscopy (\\\u003C 1 year ago), or \\[2\\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy)\n5. Women who have undergone a hysterectomy, bilateral oophorectomy, or tubal ligation, as well as those who are postmenopausal (\\> 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \\[FSH\\] level \\> 40 IU\u002FL) will not be required to use contraceptives.\n6. Willing to forgo donations of blood, or any other tissues during the study.\n\n   Additional Inclusion criteria for PLWH\n7. Confirmed HIV infection (HIV Ab+ or HIV RNA+) by documentation in the medical records or in-clinic HIV testing on screening visit.\n8. CD4 ≥ 500 cells\u002Fµl at screening.\n9. Currently on ART, and documentation of continuous combination ART (cART) for at least 12 months with suppression of plasma HIV-1 viral load \\\u003C 50 copies \u002F ml for greater than 6 months prior to trial entry, measured on at least 2 independent occasions that can include the screening viral load. cART is defined as a regimen including ≥ 2 compounds, e.g., 2 nucleoside reverse transcriptase inhibitors plus either non-nucleoside reverse transcriptase inhibitor or protease inhibitor or integrase inhibitor.\n10. Viral load \\\u003C 50 copies \u002F ml at time of screening (within 28 days prior to IP administration).\n11. Must commit to adhering to a suppressive ART regimen for the duration of the study\n\nExclusion Criteria:\n\n1. Any clinically significant acute or chronic medical condition, other than HIV infection (in Part B only), that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study.\n2. For the PLWH (Part B), history of AIDS-defining illness or CD4 \\\u003C 200 cells\u002Fµl.\n3. If female, pregnant, lactating or planning a pregnancy during the period of screening through completion of the study.\n4. In the past 6 months a history of alcohol or substance use, judged by the Investigator to potentially interfere with participant study compliance.\n\nBleeding disorder that was diagnosed by a physician (e.g., Factor deficiency, coagulopathy or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience, is eligible.\n\n6\\. History of a splenectomy. 7. Previous receipt of an adenovirus vectored vaccine. 8. Receipt of live attenuated vaccine or other vaccine within the previous 60 days or planned receipt within 180 days after administration of IP. Receipt of blood transfusion or blood derived products within the previous 3 months.\n\n9\\. Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study.\n\n10\\. Prior receipt of an investigational HIV vaccine candidate, monoclonal antibody or polyclonal immunoglobulin (note: receipt of placebo in a previous HIV vaccine or monoclonal antibody trial will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval).\n\n11\\. History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulties, angioedema).\n\n12\\. Psychiatric condition that compromises safety of the participant and precludes compliance with the protocol. Specifically excluded are persons with history of psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.\n\n13\\. If, in the opinion of the Principal Investigator or designee, it is not in the best interest of the participant to participate in the trial.\n\n14\\. Seizure disorder: a participant who has had a seizure in the last 3 years is excluded. (Not excluded: a participant with a history of seizures who has neither required medications nor had a seizure for 3 years.) 15. Infectious disease: chronic hepatitis B infection (HbsAg positive), current hepatitis C infection (HCV Ab positive and\u002F or HCV RNA) or treatment for hepatitis C infection in the past year, or active syphilis (RPR confirmed by TPHA).\n\n16\\. A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy.\n\n17\\. Active, serious infections (other than HIV infection in PLWH) requiring parenteral antibiotic, antiviral or antifungal therapy within 30 days prior to enrollment.\n\n18\\. Any abnormal laboratory parameters at screening per protocol. 19. Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease, other than HIV among the PLWH; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the investigator within the previous 6 months.\n\nEligibility Criteria Specific to PLWoH (Part A) People living without HIV(PLWoH) at screening, must be deemed to be at low risk of HIV infection and willing to maintain low-risk behavior for the duration of the trial.",{"count":102,"type":22},120,[25],"A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine (GRAdHIVNE1 Vaccine), Administered to Healthy Adults Living without HIV and Living with HIV, in Southern Africa",[106],"HIV",[108],"GRAdHIVNE1 Vaccine","2026-02-11",{"date":111,"type":39},"2026-02-13",{"date":113,"type":39},"2025-07-28",{"date":115,"type":22},"2027-03-31",{"name":45,"class":46},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":16,"sex":17,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":122,"conditions":129,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":137,"locationsCount":47},"100506003","phase-2-a-lassa-fever-vaccine-trial-in-adults-and-children-residing-in-west-africa-100506003","NCT05868733","A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa","A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults and Children Residing in West Africa","Inclusion Criteria:\n\n* Adults, adolescents, and children in good general health as assessed by medical history and physical examination (group-specific criteria apply).\n* At least 18 months old on the day of screening and not more than 70 years old on the day of vaccination (group-specific criteria apply).\n* Participant or parent\u002Fguardian willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.\n* In the opinion of the Principal Investigator (PI) or designee and based on Assessment of Informed Consent Understanding (AOU), participant or parent\u002Fguardian has understood the information provided and potential impact and\u002For risks linked to administration and participation in the trial; written informed consent will be obtained before any study-related procedures are performed. Children old enough to understand the procedures will be asked to assent, in addition to parent\u002Fguardian consent, in accordance with local requirements.\n* Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results (group-specific timepoints apply).\n* All participants of child-bearing potential engaging in sexual activity that could lead to pregnancy must commit to use an effective hormonal contraception or intrauterine device beginning 2 weeks prior and extending for 4 months following receipt of vaccine\u002Fplacebo. Study sites will choose which methods are most appropriate for their population and this will be specified in the Informed Consent Document (ICD).\n* All sexually active participants must consistently use male or female condoms with all sexual partners for 4 months following IP administration.\n* All participants who are not engaging in sexual activity that could lead to pregnancy at screening must agree to utilize an effective method of contraception if they begin engaging in sexual activity that could lead to pregnancy, as outlined above.\n* All participants of childbearing potential must be willing to undergo a pregnancy test at time points indicated in the SOA.\n* Willing to forgo donation of blood or any other tissues for transfusion or transplantation, from screening onward throughout the course of the study.\n\nAdditional Inclusion Criteria For HIV-Infected Participants\n\n* Adults who are HIV-infected must meet the following additional inclusion criteria:\n* Participant must be aged at least 18 years old on the day of screening and not more than 50 years old on the day of vaccination.\n* Participant must have documented HIV-1 or HIV-2 infection for at least 6 months prior to screening.\n* Participant must be on a stable (at least 6 months) regimen of Highly Active Antiretroviral Therapy (HAART), as defined as potent anti-HIV treatment including a combination of antiretroviral agents (pre- or post-exposure prophylaxis does not count as HAART).\n* Participant entering the study should have a screening viral load \\\u003C50 copies\u002Fml.\n* Participant must be willing to continue their HAART and HIV care follow up throughout the study as directed by their regular caregiver and be willing to give access to records of their ongoing care.\n* Participant must be in an otherwise reasonably good medical condition (absence of acquired immunodeficiency syndrome \\[AIDS\\]-defining illnesses or clinically significant disease), diagnosed based on physical examination, medical history, and the investigator's clinical judgment.\n\nAdditional Inclusion Criteria for Pediatric Participants\n\n* Each potential pediatric study participant must meet all of the following additional criteria to be enrolled in the study:\n* Parent(s)\u002Flegal guardian must have signed an ICD indicating that they understand the purpose and procedures required for the study, are willing\u002Fable to adhere to the study requirements and are willing for their child to participate in the study. Assent must be obtained from adolescents and children in accordance with local regulations and practice. Parent(s)\u002Flegal guardian must pass the AOU.\n* Participant's age on the day of vaccination is within one of the 3 age strata in the study: 12-17 years, 6-11 years, or 18 months -5 years.\n* Participant must be healthy in the investigator's clinical judgment (and the parent(s)\u002Flegal guardian's judgment) based on medical history, physical examination and vital signs performed at screening.\n* A female adolescent who is of childbearing potential must comply with requirements for contraception.\n* Adolescents who are sexually active must comply with requirement for use of condoms for 4 months after vaccination.\n* Participant has received all routine immunizations appropriate for their age as reported by the parent(s)\u002Flegal guardian, according to local routine vaccination schedules. Participants are allowed to catch up on routine immunizations if needed or as part of national immunization campaigns. However, Exclusion Criteria #9 will apply.\n\nExclusion Criteria:\n\n* Confirmed HIV-1 or HIV-2 infection (except as outlined for Group 2)\n* Any clinically relevant abnormality on history or examination including history of immunodeficiency (except for Group 2) or autoimmune disease; use of corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the Investigator within the previous 6 months. The following exceptions are permitted and will not preclude study participation: use of corticosteroid nasal spray for rhinitis, 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 Investigator clinical judgment) at least 2 weeks prior to enrollment in this study.\n* Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study (except for HIV in Group 2). Note: Participants aged \\>50years with the following chronic but controlled conditions may be enrolled:\n* Hypertension with systolic ≤150 mmHg and\u002For diastolic ≤90 mmHg; (regardless of treatment status)\n* Diabetes mellitus with a HbA1C \\\u003C10% and \u002For with type 2 diabetes mellitus on stable medication for at least 2 months prior to enrollment.\n* Pregnant or lactating.\n* Bleeding disorder that was diagnosed by a physician (eg, factor deficiency, coagulopathy, or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible.\n* Infectious disease: chronic active hepatitis B infection (HBsAg-positive), current hepatitis C infection, prior clinical diagnosis of Lassa Fever disease (LF) or Ebola virus disease (EVD) by medical history, active syphilis (positive screening and confirmatory tests unless adequately treated), positive viral detection test for SARS-CoV-2. Note: COVID-19 screening is not applicable for Group 5.\n* History of splenectomy or functional asplenia.\n* Any of the following abnormal laboratory parameters listed below:\n* Hematology\n* Absolute Neutrophil Count (ANC): ≤1,000 cells\u002Fmm3 or ≤ 1.0 × 109 cells\u002FL\n* Absolute Lymphocyte Count (ALC): ≤650 cells\u002Fmm3 or ≤ 0.65 × 109 cells\u002FL\n* Hemoglobin: \\\u003C9.5 g\u002Fdl in females; \\\u003C11.0 g\u002Fdl in males; \\\u003C10 g\u002Fdl in children \\\u003C11 years of age\n* Platelets \\\u003C100,000 cells\u002Fmm3\n* Chemistry\n* Creatinine \\>1.1 x upper limit of normal (ULN) (Note: For participants aged \\>50 years clinically insignificant renal insufficiency defined as creatinine ≤1.3 x ULN is allowed)\n* Alanine transaminase (ALT) \\>1.25 x ULN\n* Aspartate transaminase (AST) \\>1.25 x ULN\n* Urinalysis (not applicable for group 5)\n* Clinically significant abnormal dipstick confirmed by repeat dipstick on new specimen or by microscopy\n* Protein = 1+ or more\n* Blood = 2+ or more (not due to menses) (Urinalysis may be collected within the following 2 weeks if menses interfere)\n* Receipt of any vaccine within the previous 28 days or planned receipt within 28 days after vaccination with IP. Participation may be delayed until this criterion can be fulfilled. Note: prior receipt of VSV-vectored vaccines such as VSV-ZEBOV will be documented but is not an exclusion criterion.\n* Prior receipt of another investigational Lassa vaccine candidate. Note: receipt of placebo in a previous LF vaccine trial will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval.\n* Receipt of blood transfusion or blood-derived products within the previous 3 months.\n* Participation in another clinical trial or observational study currently, within the previous 3 months, or expected participation during this study, unless Medical Monitor approves.\n* History of severe local or systemic reactogenicity to any vaccine (eg, anaphylaxis, respiratory difficulties, angioedema, injection site necrosis, or ulceration).\n* Psychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol. Specifically excluded are persons with psychoses in the last 3 years prior to screening, ongoing risk for suicide, or history of suicide attempt or gesture in the last 3 years prior to screening.\n* Seizure disorder: A participant who has had a seizure in the last 3 years prior to screening or has been on any medication to control or prevent seizures for the last 3 years is excluded. Group 5: History of febrile seizures is an exclusion criterion.\n* A history of malignancy in the past 5 years (prior to screening) or ongoing malignancy (a history of a completely excised malignancy that is considered cured is not an exclusion).\n* Active, serious infections requiring parenteral antibiotic, antiviral, antiparasitic or antifungal therapy within 30 days prior to enrollment (except HAART treatment in Group 2). Asymptomatic malaria infection at study entry will be assessed retrospectively and will not be a basis for exclusion.\n* Group specific weight for height restrictions as indicated below:\n* Groups 1 and 2: Obesity as defined by Body mass index (BMI) ≥35.\n* Group 3: Obesity as defined by weight for height 2 standard deviation (SD) from median according to WHO growth charts or underweight as defined by weight for height or weight for length ≤-2 SD from median according to WHO growth charts\n* Groups 4 and 5: Underweight as defined by weight for height or weight for length ≤ 2 SD from median according to WHO growth charts (see APPENDIX C) and\u002For weighing \\\u003C10kg.\n* Group specific hearing thresholds or otoacoustic emission (OAE) results at 0.5-4KHz as indicated below:\n* Moderate or greater hearing impairment defined as 35dB in any frequency in either ear as revealed via the audiometry exam for Groups 1 and 2.\n* Mild or greater hearing impairment defined as ≥20dB in any frequency in either ear as revealed via the audiometry exam for adolescents and children aged \\>7years.\n\nFor children 7 years of age and younger (or unable to follow pure tone audiometry procedure) \"refer\" test results as determined by OAE.\n\n* Otorrhea within the past 90 days, sudden or rapid hearing loss within the past 90 days, acute or chronic dizziness, otalgia (external ear otalgia is not an exclusion)\n* Clinically relevant abnormal otoscopy, that in the opinion of the investigator, may interfere with hearing. (Participants with conditions that can be treated prior to enrolment such as cerumen obstruction are not excluded)\n* History of acute or chronic or severe neurologic condition (eg, diagnosis of Guillain-Barré syndrome, epilepsy, Bell's palsy, meningitis, or disease with any focal neurologic deficits).\n* Current of past significant risk factors for hearing loss (eg, occupational exposure to loud noise or medical illness) that, in the opinion of the investigator, may interfere with the detection of changes in hearing during the study.\n* History of any condition associated with sensorineural hearing loss that, in the opinion of the investigator, may cause changes in hearing during the study (eg, occupational exposure to loud noise or medical illness).\n* If, in the opinion of the PI, it is not in the best interest of the participant to participate in the study.","18 Months","70 Years",{"count":127,"type":22},612,[80],[130],"Lassa Fever","2025-05-07",{"date":133,"type":39},"2025-05-11",{"date":135,"type":39},"2024-03-06",{"date":43,"type":22},{"name":45,"class":46},""]