protocolSection identificationModule nctId: NCT06332339, orgStudyIdInfo id: HVTN 313, briefTitle: Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2026-11-11, completionDateStruct date: 2026-11-11, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, descriptionModule briefSummary: The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV.The main question\[s\] it aims to answer are:* Are these vaccine regimens safe and well tolerated?* Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses?Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary., conditionsModule conditions: HIV, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 16055 NFL delta Gly4 trimer, interventions name: Trimer 4571, interventions name: Ad4-Env145NFL, 5 x 108 viral particles (vp), outcomesModule primaryOutcomes measure: Local reactogenicity signs and symptoms, primaryOutcomes measure: Systemic reactogenicity signs and symptoms, primaryOutcomes measure: Number of adverse events (AEs) reported for 30 days after receipt of any study product, primaryOutcomes measure: Number of Serious Adverse Reactions (SAEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of Medically Attended Adverse Event (MAAEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of Adverse Events of Special Interest (AESIs) that are Potential Immune Mediated Medical Conditions (PIMMCs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Occurrence of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc), primaryOutcomes measure: Magnitude of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.), primaryOutcomes measure: Response Rate of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.), secondaryOutcomes measure: Occurrence of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086), secondaryOutcomes measure: Magnitude of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086), secondaryOutcomes measure: Response Rate of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086), secondaryOutcomes measure: Occurrence of serum antibody neutralization of HIV-1 strains, secondaryOutcomes measure: Magnitude of serum antibody neutralization of HIV-1 strains, secondaryOutcomes measure: Response Rate of serum antibody neutralization of HIV-1 strains, secondaryOutcomes measure: Flow cytometry analysis of the frequency of Env-specific IgG+ B cells, secondaryOutcomes measure: Occurrence of serum IgG binding antibodies as measured by BAMA, secondaryOutcomes measure: Magnitude of serum IgG binding antibodies as measured by BAMA, secondaryOutcomes measure: Response Rate of serum IgG binding antibodies as measured by BAMA, secondaryOutcomes measure: Number of Isolation of CD4bs bnAb specific VH and VL alleles and characteristic mutations, secondaryOutcomes measure: Flow cytometry analysis of the frequency of Env-specific IgG+ B cells at 26 weeks and 52 weeks after the fifth vaccination, secondaryOutcomes measure: Occurrence of serum IgG binding antibodies, secondaryOutcomes measure: Magnitude of serum IgG binding antibodies, secondaryOutcomes measure: Response Rate of serum IgG binding antibodies, secondaryOutcomes measure: Occurrence of serum antibody neutralization to tier 2 HIV-1 strains, secondaryOutcomes measure: Magnitude of serum antibody neutralization to tier 2 HIV-1 strains, secondaryOutcomes measure: Response Rate of serum antibody neutralization to tier 2 HIV-1 strains, secondaryOutcomes measure: Epitope specific response rates as measured by electron microscopy polyclonal epitope mapping (EMPEM), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alabama CRS, status: NOT_YET_RECRUITING, city: Birmingham, state: Alabama, zip: 35222, country: United States, contacts name: Heather Logan, ANP, role: CONTACT, phone: 205-873-8686, email: heatherlogan@uabmc.edu, geoPoint lat: 33.52066, lon: -86.80249, locations facility: The Ponce de Leon Center CRS, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30308, country: United States, contacts name: Erika Patrick, MSN, role: CONTACT, phone: 404-616-6313, email: erpatri@emory.edu, geoPoint lat: 33.749, lon: -84.38798, locations facility: Brigham and Women's Hospital Vaccine CRS (BWH VCRS), status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Jose Licona, MD, role: CONTACT, phone: 617-525-9433, email: jlicona@partners.org, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Columbia Partnership for Prevention and Control of HIV/AIDS CTU, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts name: Mascha Elskamp, role: CONTACT, phone: 212-305-2201, email: Me2500@cumc.columbia.edu, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Rochester HIV/AIDS CTU, status: NOT_YET_RECRUITING, city: Rochester, state: New York, zip: 14642, country: United States, contacts name: Catherine Bunce, RN MS, CCRC, role: CONTACT, phone: 585-275-5871, email: catherine_bunce@urmc.rochester.edu, geoPoint lat: 43.15478, lon: -77.61556, locations facility: University of Pennsylvania HIV Therapeutics and Prevention Clinical Trials Unit, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Debora Dunbar, MSN, CRNP, role: CONTACT, phone: 215-746-3713, email: ddunbar@pennmedicine.upenn.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False