A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials
Developing an effective HIV vaccine is a momentous challenge. An exceptionally wide range of candidate HIV vaccines have been tested, yet many were poorly immunogenic, and of the select few that advanced into efficacy trials, only one demonstrated any efficacy. Here we report the results of the larg...
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2025-12-01
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| author | Zoe Moodie Shuying Sue Li Elena E. Giorgi LaTonya D. Williams One Dintwe Lindsay N. Carpp Shiyu Chen Kelly E. Seaton Sheetal S. Sawant Lu Zhang Jack Heptinstall Shuying Liu Nicole Grunenberg Frank Tomaka Supachai Rerks-Ngarm Punnee Pitisuttithum Sorachai Nitayaphan Julie A. Ake Sandhya Vasan Giuseppe Pantaleo Ian Frank Lindsey R. Baden Paul A. Goepfert Michael Keefer Mike Chirenje Mina C. Hosseinipour Kathryn Mngadi Fatima Laher Nigel Garrett Linda-Gail Bekker Stephen De Rosa Erica Andersen-Nissen James G. Kublin Shan Lu Peter B. Gilbert Glenda E. Gray Lawrence Corey M. Juliana McElrath Georgia D. Tomaras |
| author_facet | Zoe Moodie Shuying Sue Li Elena E. Giorgi LaTonya D. Williams One Dintwe Lindsay N. Carpp Shiyu Chen Kelly E. Seaton Sheetal S. Sawant Lu Zhang Jack Heptinstall Shuying Liu Nicole Grunenberg Frank Tomaka Supachai Rerks-Ngarm Punnee Pitisuttithum Sorachai Nitayaphan Julie A. Ake Sandhya Vasan Giuseppe Pantaleo Ian Frank Lindsey R. Baden Paul A. Goepfert Michael Keefer Mike Chirenje Mina C. Hosseinipour Kathryn Mngadi Fatima Laher Nigel Garrett Linda-Gail Bekker Stephen De Rosa Erica Andersen-Nissen James G. Kublin Shan Lu Peter B. Gilbert Glenda E. Gray Lawrence Corey M. Juliana McElrath Georgia D. Tomaras |
| author_sort | Zoe Moodie |
| collection | DOAJ |
| description | Developing an effective HIV vaccine is a momentous challenge. An exceptionally wide range of candidate HIV vaccines have been tested, yet many were poorly immunogenic, and of the select few that advanced into efficacy trials, only one demonstrated any efficacy. Here we report the results of the largest-scale cross-protocol immunogenicity comparison to date: 13 HIV vaccine trials (including 36 vaccine regimens) conducted across nine countries worldwide, strengthened by standardized trial designs, validated assays in centralized laboratories, and harmonized immunogenicity endpoints – providing an objective approach to identify the HIV vaccine candidate(s) with the best immunogenicity. A polyvalent DNA prime + protein boost regimen (HVTN 124) including Env immunogens of four subtypes, matched between prime and boost, achieved the best anti-V1V2 antibody responses by a large margin and also induced high CD4+ T-cell responses – two key immune responses implicated in HIV vaccine protection. Our results provide strong support to test this promising HIV vaccine design in more advanced phase clinical trials and will also guide the future design of additional HIV vaccines.Trial registration: ClinicalTrials.gov identifier: NCT01799954..Trial registration: ClinicalTrials.gov identifier: NCT02109354..Trial registration: ClinicalTrials.gov identifier: NCT02404311..Trial registration: ClinicalTrials.gov identifier: NCT02207920..Trial registration: ClinicalTrials.gov identifier: NCT02296541..Trial registration: ClinicalTrials.gov identifier: NCT03284710..Trial registration: ClinicalTrials.gov identifier: NCT02915016..Trial registration: ClinicalTrials.gov identifier: NCT02997969..Trial registration: ClinicalTrials.gov identifier: NCT03122223..Trial registration: ClinicalTrials.gov identifier: NCT03409276..Trial registration: ClinicalTrials.gov identifier: NCT02968849..Trial registration: ClinicalTrials.gov identifier: NCT03060629..Trial registration: ClinicalTrials.gov identifier: NCT00223080.. |
| format | Article |
| id | doaj-art-d25df2b9ad6a4d0dae8d43ff28864daa |
| institution | OA Journals |
| issn | 2222-1751 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Emerging Microbes and Infections |
| spelling | doaj-art-d25df2b9ad6a4d0dae8d43ff28864daa2025-08-20T02:08:12ZengTaylor & Francis GroupEmerging Microbes and Infections2222-17512025-12-0114110.1080/22221751.2025.2485317A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trialsZoe Moodie0Shuying Sue Li1Elena E. Giorgi2LaTonya D. Williams3One Dintwe4Lindsay N. Carpp5Shiyu Chen6Kelly E. Seaton7Sheetal S. Sawant8Lu Zhang9Jack Heptinstall10Shuying Liu11Nicole Grunenberg12Frank Tomaka13Supachai Rerks-Ngarm14Punnee Pitisuttithum15Sorachai Nitayaphan16Julie A. Ake17Sandhya Vasan18Giuseppe Pantaleo19Ian Frank20Lindsey R. Baden21Paul A. Goepfert22Michael Keefer23Mike Chirenje24Mina C. Hosseinipour25Kathryn Mngadi26Fatima Laher27Nigel Garrett28Linda-Gail Bekker29Stephen De Rosa30Erica Andersen-Nissen31James G. Kublin32Shan Lu33Peter B. Gilbert34Glenda E. Gray35Lawrence Corey36M. Juliana McElrath37Georgia D. Tomaras38Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USACenter for Human Systems Immunology, Duke University School of Medicine, Durham, NC, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USACenter for Human Systems Immunology, Duke University School of Medicine, Durham, NC, USACenter for Human Systems Immunology, Duke University School of Medicine, Durham, NC, USACenter for Human Systems Immunology, Duke University School of Medicine, Durham, NC, USACenter for Human Systems Immunology, Duke University School of Medicine, Durham, NC, USAWorcester HIV Vaccine, Worcester, MA, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USADepartment of Research & Development, Janssen Vaccines and Prevention/Johnson & Johnson, Titusville, NJ, USAThai Ministry of Public Health, Nonthaburi, ThailandVaccine Trials Center, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandRoyal Thai Army, Armed Forces Research Institute of Medical Sciences, Bangkok, ThailandU.S. Military HIV Research Program, CIDR, Walter Reed Army Institute of Research, Silver Spring, MD, USAU.S. Military HIV Research Program, CIDR, Walter Reed Army Institute of Research, Silver Spring, MD, USAService of Immunology and Allergy, Lausanne University Hospital and University of Lausanne, Lausanne, SwitzerlandInfectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, PA, USADepartment of Medicine, Brigham and Women's Hospital, Boston, MA, USADepartment of Medicine, University of Alabama at Birmingham, Birmingham, AL, USADepartment of Medicine, University of Rochester, Rochester, NY, USACollege of Health Sciences Clinical Trials Research Centre, University of Zimbabwe, Harare, ZimbabweUNC-Project Malawi, Lilongwe, MalawiClinical Research Division, Aurum Institute, Johannesburg, South AfricaPerinatal HIV Research Unit (PHRU), Wits Health Consortium, Faculty of Health Sciences, University of the Witwatersrand, Soweto, Johannesburg, South AfricaDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South AfricaDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South AfricaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USAWorcester HIV Vaccine, Worcester, MA, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USAPerinatal HIV Research Unit (PHRU), Wits Health Consortium, Faculty of Health Sciences, University of the Witwatersrand, Soweto, Johannesburg, South AfricaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USACenter for Human Systems Immunology, Duke University School of Medicine, Durham, NC, USADeveloping an effective HIV vaccine is a momentous challenge. An exceptionally wide range of candidate HIV vaccines have been tested, yet many were poorly immunogenic, and of the select few that advanced into efficacy trials, only one demonstrated any efficacy. Here we report the results of the largest-scale cross-protocol immunogenicity comparison to date: 13 HIV vaccine trials (including 36 vaccine regimens) conducted across nine countries worldwide, strengthened by standardized trial designs, validated assays in centralized laboratories, and harmonized immunogenicity endpoints – providing an objective approach to identify the HIV vaccine candidate(s) with the best immunogenicity. A polyvalent DNA prime + protein boost regimen (HVTN 124) including Env immunogens of four subtypes, matched between prime and boost, achieved the best anti-V1V2 antibody responses by a large margin and also induced high CD4+ T-cell responses – two key immune responses implicated in HIV vaccine protection. Our results provide strong support to test this promising HIV vaccine design in more advanced phase clinical trials and will also guide the future design of additional HIV vaccines.Trial registration: ClinicalTrials.gov identifier: NCT01799954..Trial registration: ClinicalTrials.gov identifier: NCT02109354..Trial registration: ClinicalTrials.gov identifier: NCT02404311..Trial registration: ClinicalTrials.gov identifier: NCT02207920..Trial registration: ClinicalTrials.gov identifier: NCT02296541..Trial registration: ClinicalTrials.gov identifier: NCT03284710..Trial registration: ClinicalTrials.gov identifier: NCT02915016..Trial registration: ClinicalTrials.gov identifier: NCT02997969..Trial registration: ClinicalTrials.gov identifier: NCT03122223..Trial registration: ClinicalTrials.gov identifier: NCT03409276..Trial registration: ClinicalTrials.gov identifier: NCT02968849..Trial registration: ClinicalTrials.gov identifier: NCT03060629..Trial registration: ClinicalTrials.gov identifier: NCT00223080..https://www.tandfonline.com/doi/10.1080/22221751.2025.2485317Binding antibody multiplex assaycross-protocol analysisEnv V1V2 binding antibody response breadth scoreintracellular cytokine stainingmatched polyvalent DNA-polyvalent protein/GLA-SE prime-boost regimen |
| spellingShingle | Zoe Moodie Shuying Sue Li Elena E. Giorgi LaTonya D. Williams One Dintwe Lindsay N. Carpp Shiyu Chen Kelly E. Seaton Sheetal S. Sawant Lu Zhang Jack Heptinstall Shuying Liu Nicole Grunenberg Frank Tomaka Supachai Rerks-Ngarm Punnee Pitisuttithum Sorachai Nitayaphan Julie A. Ake Sandhya Vasan Giuseppe Pantaleo Ian Frank Lindsey R. Baden Paul A. Goepfert Michael Keefer Mike Chirenje Mina C. Hosseinipour Kathryn Mngadi Fatima Laher Nigel Garrett Linda-Gail Bekker Stephen De Rosa Erica Andersen-Nissen James G. Kublin Shan Lu Peter B. Gilbert Glenda E. Gray Lawrence Corey M. Juliana McElrath Georgia D. Tomaras A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials Emerging Microbes and Infections Binding antibody multiplex assay cross-protocol analysis Env V1V2 binding antibody response breadth score intracellular cytokine staining matched polyvalent DNA-polyvalent protein/GLA-SE prime-boost regimen |
| title | A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials |
| title_full | A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials |
| title_fullStr | A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials |
| title_full_unstemmed | A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials |
| title_short | A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials |
| title_sort | polyvalent dna prime with matched polyvalent protein gla se boost regimen elicited the most robust and broad igg and igg3 v1v2 binding antibody and cd4 t cell responses among 13 hiv vaccine trials |
| topic | Binding antibody multiplex assay cross-protocol analysis Env V1V2 binding antibody response breadth score intracellular cytokine staining matched polyvalent DNA-polyvalent protein/GLA-SE prime-boost regimen |
| url | https://www.tandfonline.com/doi/10.1080/22221751.2025.2485317 |
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polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT fatimalaher polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT nigelgarrett polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT lindagailbekker polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT stephenderosa polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT ericaandersennissen polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT jamesgkublin polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT shanlu polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT peterbgilbert polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT glendaegray polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT lawrencecorey polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT mjulianamcelrath polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials AT georgiadtomaras polyvalentdnaprimewithmatchedpolyvalentproteinglaseboostregimenelicitedthemostrobustandbroadiggandigg3v1v2bindingantibodyandcd4tcellresponsesamong13hivvaccinetrials |