[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563509":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":50,"studyPopulation":38,"armGroups":51,"interventions":63,"overallOfficials":75,"centralContacts":86,"locations":96,"responsibleParty":129,"collaborators":131,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":147,"sex":148,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":38,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":99,"whyStopped":38,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"International AIDS Vaccine Initiative","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":38},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Assess safety and tolerability of GRAdHIVNE1 vaccine","1\\. Proportion of participants with each type of reactogenicity event classified by severity of the events from initial administration through 7 days following completion of each dose of the investigational product.","7 Day",{"measure":14,"description":15,"timeFrame":16},"Assessment of unsolicited adverse events (AEs)","Proportion of participants reporting unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, classified by severity and causality, from initial administration through 28 days following completion of each dose of the investigational product.","28 day",{"measure":18,"description":19,"timeFrame":20},"Assessment of SAEs","Proportion of participants reporting serious adverse events (SAEs) throughout the study period, classified by causality.","19 months",[22,26,28,30,32,34,36],{"measure":23,"description":24,"timeFrame":25},"To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.","1\\. Response rate and magnitude of the vaccine induced HIV specific T cell response at peak immunogenicity as measured by intracellular cytokine staining assay or IFNγ ELISpot assay after each dose.","19 Months",{"measure":23,"description":27,"timeFrame":20},"To assess antigen specific proliferative memory T cell responses induced by vaccination.",{"measure":23,"description":29,"timeFrame":20},"To identify immunogenic epitopes within the vaccine immunogen and define the HLA restriction.",{"measure":23,"description":31,"timeFrame":20},"To define the functional characteristics of antigen specific T cells by assessing proliferation, cytotoxicity, tetramer analysis and TCR sequences.",{"measure":23,"description":33,"timeFrame":20},"To evaluate vaccine induced innate immune responses.",{"measure":23,"description":35,"timeFrame":20},"To characterize vaccine induced de novo T-cell responses compared to pre-existing responses in PLWH (Part B).",{"measure":23,"description":37,"timeFrame":20},"To conduct analyses to further understand HIV and vaccine immunology",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":44,"maskingDescription":45,"whoMasked":46},"TRIPLE","Randomized controlled Double - blinded",[47,48,49],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","This is a Phase 1 trial for the GRAdHIVNE1 vaccine, designed to evaluate safety, tolerability, and immunogenicity in healthy individuals (PLWoH) including healthy People Living with HIV (PLWH). This study builds on insights from prior T-cell vaccine trials and pre-clinical non-human primate studies, which demonstrated that robust CD8+ T cell responses, are crucial for viral control but require broad, polyfunctional responses that can also effectively counteract HIV's diversity and immune evasion strategies. Inclusion of PLWoH and PLWH in this study is important for safety, tolerability and immunogenicity data that can inform further development of the vaccine for prevention and therapeutic use. Prior clinical trials, using adenovirus vectors and exploring different vaccine approaches, demonstrated safety and potential immunogenic benefits in PLWH, despite not achieving sustained viral suppression post-treatment interruption Understanding these dynamics is key to evaluating the full therapeutic potential of vaccine induced immune responses in controlling HIV as well as inform the potential of the vaccine in aborting the establishment of a disseminated infection in the setting of prevention.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"People living with HIV (PLWH) and People living without HIV (PLWoH)","EXPERIMENTAL","Participants living without HIV (PLWoH) will be assigned to receive either a single dose, 2 doses of the GRAdHIVNE1 vaccine, or placebo. Participants living with HIV (PLWH) will be assigned to receive either 2 doses of the GRAdHIVNE1 vaccine, or placebo.\n\nEach participant is to receive GRAdHIVNE1 at vaccine dose 5x10\\^10 or 2x10\\^11 or to receive placebo.",[57],"Drug: GRAdHIVNE1 Vaccine",{"label":59,"type":60,"description":55,"interventionNames":61},"Placebo NaCl for injection","PLACEBO_COMPARATOR",[62],"Other: Placebo",[64,71],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"DRUG","GRAdHIVNE1 Vaccine","This is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups.",[53],[70],"gorilla-isolated adenovirus (GRAd32) vector",{"type":72,"name":73,"description":67,"armGroupLabels":74,"otherNames":38},"OTHER","Placebo",[59],[76,80,83],{"name":77,"affiliation":78,"role":79},"Theodorah Ndzhukule","Desmond Tutu Health Foundation","PRINCIPAL_INVESTIGATOR",{"name":81,"affiliation":82,"role":79},"Limakatso Lebina","Africa Health Research Institute (AHRI)",{"name":84,"affiliation":85,"role":79},"Tariro Makadzange","Mutala Trust",[87,92],{"name":88,"role":89,"phone":90,"phoneExt":38,"email":91},"Vincent Muturi-Kioi, MBChB","CONTACT","+254-71-904-3151","VMuturi-Kioi@iavi.org",{"name":93,"role":89,"phone":94,"phoneExt":38,"email":95},"Lebohang Molife, MBChB","+27 76 866 7282","LMolife@iavi.org",[97,110,119],{"facility":98,"status":99,"city":100,"state":101,"zip":38,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":38},"AHRI","RECRUITING","Mtubatuba","KwaZulu-Natal","South Africa","ZA",{"type":105,"coordinates":106},"Point",[107,108],32.18483,-28.41789,{"lat":108,"lon":107},{"facility":111,"status":99,"city":112,"state":113,"zip":38,"country":102,"countryCode":103,"cosmosGeoPoint":114,"geoPoint":118,"contacts":38},"DTHF","Cape Town","Western Cape",{"type":105,"coordinates":115},[116,117],18.42322,-33.92584,{"lat":117,"lon":116},{"facility":120,"status":99,"city":121,"state":121,"zip":38,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":128,"contacts":38},"Mutala","Harare","Zimbabwe","ZW",{"type":105,"coordinates":125},[126,127],31.05337,-17.82772,{"lat":127,"lon":126},{"type":130,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[132,135,138],{"name":133,"class":134},"Ragon Institute","UNKNOWN",{"name":136,"class":137},"ReiThera Srl","INDUSTRY",{"name":85,"class":134},"100563509","phase-1-a-trial-of-a-gorilla-adenovirus-vectored-networked-epitopes-vaccine-administered-to-healthy-adults-living-without-and-with-hiv-100563509",false,"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.",true,"ALL","18 Years","50 Years",{"count":152,"type":153},120,"ESTIMATED","INTERVENTIONAL",[156],"PHASE1","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",[159],"HIV",[66],"2026-02-11",{"date":163,"type":164},"2026-02-13","ACTUAL",{"date":166,"type":164},"2025-07-28",{"date":168,"type":153},"2027-03-31",{"name":5,"class":6},3]