protocolSection identificationModule nctId: NCT06267872, orgStudyIdInfo id: HVTN 309, briefTitle: A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-12-12, completionDateStruct date: 2026-07-11, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, collaborators name: National Institutes of Health (NIH), collaborators name: Department of Health and Human Services, collaborators name: Duke University, collaborators name: Access to Advanced Health Institute (AAHI), descriptionModule briefSummary: This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed., conditionsModule conditions: HIV, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: CD4BS CH505M5 Pr-NP1, interventions name: CH505TF chTrimer, interventions name: 3M-052-AF (labeled as AP 60-702), interventions name: Aluminum Hydroxide Suspension (Alum), interventions name: ACU-026-001-1 (labeled as empty LNP), outcomesModule primaryOutcomes measure: Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine, primaryOutcomes measure: Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine, primaryOutcomes measure: Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of adverse events of special interest (AESIs) 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: Part C only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry, primaryOutcomes measure: Part C only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay, primaryOutcomes measure: Part C only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay, secondaryOutcomes measure: Parts B and C: Response rate of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA), secondaryOutcomes measure: Parts B and C: Magnitude of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA), secondaryOutcomes measure: Part B only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay, secondaryOutcomes measure: Part B only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay, secondaryOutcomes measure: Parts B and C: Response rate of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay, secondaryOutcomes measure: Parts B and C: Magnitude of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay, secondaryOutcomes measure: Parts B and C: Response rate of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay, secondaryOutcomes measure: Parts B and C: Magnitude of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay, secondaryOutcomes measure: Parts B and C: Response rate of CD4+ and CD8+ T-cell responses, as measured by flow cytometry, secondaryOutcomes measure: Parts B and C: Magnitude of CD4+ and CD8+ T-cell responses, as measured by flow cytometry, secondaryOutcomes measure: Part B only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alabama CRS (Site ID: 31788), city: Birmingham, state: Alabama, zip: 35222, country: United States, contacts name: Heather Logan, A.N.P., 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 (Site ID: 5802), city: Atlanta, state: Georgia, zip: 30308, country: United States, contacts name: Ericka Patrick, M.S.N, role: CONTACT, phone: 404-616-6313, email: erpatri@emory.edu, geoPoint lat: 33.749, lon: -84.38798, locations facility: Vanderbilt Vaccine (VV) CRS (Site ID: 30352), city: Nashville, state: Tennessee, zip: 37232, country: United States, contacts name: Shonda E. Sumner, B.S.N., role: CONTACT, phone: 615-343-6906, email: Shonda.sumner@vumc.org, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Setshaba Research Centre CRS (Site ID: 31829), city: Soshanguve, state: Gauteng, zip: 0152, country: South Africa, contacts name: Magdeline K. Molapo, role: CONTACT, phone: 27-12-7992422, email: KMolapo@setshaba.org.za, locations facility: Isipingo CRS (Site ID: 31635), city: Isipingo, state: Kwa Zulu Natal, zip: 4110, country: South Africa, contacts name: Girisha Kistnasami, B.Sc., D.P.M., role: CONTACT, phone: 27-31-2423600, email: girisha.kistnasami@mrc.ac.za, geoPoint lat: -29.98639, lon: 30.91853, locations facility: Klerksdorp CRS (Site ID: 30325), city: Klerksdorp, state: North West Province, zip: 2571, country: South Africa, contacts name: Olebogeng Jonkane, role: CONTACT, phone: None Listed, email: ojonkane@auruminstitute.org, geoPoint lat: -26.85213, lon: 26.66672, hasResults: False