{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:05:47Z","timestamp":1792785947988,"version":"4.5.0"},"reference-count":46,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T00:00:00Z","timestamp":1783987200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Immuno Cure Group"},{"name":"Clinical Translational Catalyst programme of Hong Kong Science & Technology Parks Corporation","id":[{"id":"https:\/\/ror.org\/05q8mqd91","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Hong Kong Research Grants Council Theme-based Research Scheme","award":["T11-706\/18-N"],"award-info":[{"award-number":["T11-706\/18-N"]}]},{"name":"Hong Kong Research Grants Council Theme-based Research Scheme","award":["T11-702\/24-N"],"award-info":[{"award-number":["T11-702\/24-N"]}]},{"DOI":"10.13039\/501100017610","name":"Shenzhen Science and Technology Program","doi-asserted-by":"publisher","award":["JSYJ20240813102007011"],"award-info":[{"award-number":["JSYJ20240813102007011"]}],"id":[{"id":"10.13039\/501100017610","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100012166","name":"National Key R&D Program of China","doi-asserted-by":"publisher","award":["2021YFC2301900"],"award-info":[{"award-number":["2021YFC2301900"]}],"id":[{"id":"10.13039\/501100012166","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100012166","name":"National Key R&D Program of China","doi-asserted-by":"publisher","award":["2023YFC2308300"],"award-info":[{"award-number":["2023YFC2308300"]}],"id":[{"id":"10.13039\/501100012166","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Shenzhen Clinical Research Centre for Emerging Infectious Diseases","award":["LCYSSQ20220823091203007"],"award-info":[{"award-number":["LCYSSQ20220823091203007"]}]},{"name":"Shenzhen High-level Hospital Construction Fund"},{"name":"Immuno Cure Group"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Therapeutic vaccines represent a potential strategy for HIV-1 control without antiretroviral therapy (ART). We report a first-in-human study on ICVAX\u2122, a PD-1-enhanced HIV-1 therapeutic DNA vaccine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This NMPA-approved, randomized, double-blind, placebo-controlled, dose-escalation phase I trial (NCT06253533) was conducted at Shenzhen Third People's Hospital, China. Adults with HIV-1 aged 18\u201350 years on ART were sequentially allocated to 1, 2, or 4 mg dose groups of 15, each randomized 12:3 to ICVAX or placebo. Participants received intramuscular injections with electroporation at Weeks 0, 4, 8, 12, and 36. Primary safety, secondary immunological, and exploratory virological outcomes were recorded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>All 45 participants completed the trial, with 12 per ICVAX cohort and 9 in pooled Placebo. Treatment-related adverse events occurred in 100% of placebo and 83.3% of ICVAX recipients, all mild and transient, predominantly local reactions. A \u22652-fold increase of peak ELISpot T-cell responses over baseline was achieved by 75%, 75%, and 58.3% of low-dose, mid-dose, and high-dose recipients, versus 33.3% for Placebo. ICVAX recipients also showed low-frequency Gag-specific T cells expressing CD107a and\/or effector cytokines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>ICVAX was well-tolerated and elicited robust antigen-specific T-cell responses in ART-suppressed people with HIV-1. Its efficacy will be assessed in future studies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiag320","type":"journal-article","created":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T14:01:33Z","timestamp":1784037693000},"page":"361-372","source":"Crossref","is-referenced-by-count":1,"title":["Safety and Immunogenicity of a PD-1-Enhanced HIV-1 Therapeutic DNA Vaccine: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Trial in People With HIV-1 on Antiretroviral Therapy"],"prefix":"10.1093","volume":"234","author":[{"given":"Qiaoli","family":"Peng","sequence":"first","affiliation":[{"name":"National Clinical Research Centre for Infectious Diseases and Shenzhen Clinical Research Centre for Infectious Diseases, State Key Discipline of Infectious Disease, Shenzhen Third People\u2019s Hospital, Second Affiliated Hospital of Southern University of Science and Technology , Shenzhen, Guangdong ,","place":["People\u2019s Republic of China"]},{"name":"AIDS Institute, Department of Microbiology and Pandemic Research Alliance Unit, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong , Hong Kong SAR ,","place":["People\u2019s Republic of China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yik Chun","family":"Wong","sequence":"additional","affiliation":[{"name":"Yicura BioMed Limited, Hong Kong SAR ,","place":["People\u2019s Republic of China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wing Yin","family":"Cheng","sequence":"additional","affiliation":[{"name":"Yicura BioMed Limited, Hong Kong SAR ,","place":["People\u2019s Republic of China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun","family":"He","sequence":"additional","affiliation":[{"name":"National Clinical Research Centre for Infectious Diseases and Shenzhen Clinical Research Centre for Infectious Diseases, State Key Discipline of Infectious Disease, Shenzhen Third People\u2019s Hospital, Second Affiliated Hospital of Southern University of Science and Technology , Shenzhen, Guangdong ,","place":["People\u2019s Republic of China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chengxi","family":"Xie","sequence":"additional","affiliation":[{"name":"National Clinical Research Centre for Infectious Diseases and Shenzhen Clinical Research Centre for Infectious Diseases, State Key Discipline of Infectious Disease, Shenzhen Third People\u2019s Hospital, Second Affiliated Hospital of Southern University of Science and Technology , Shenzhen, Guangdong ,","place":["People\u2019s Republic of China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yirong","family":"Shi","sequence":"additional","affiliation":[{"name":"National Clinical Research Centre for Infectious Diseases and Shenzhen Clinical Research Centre for Infectious Diseases, State Key Discipline of Infectious Disease, Shenzhen Third People\u2019s Hospital, Second Affiliated Hospital of Southern University of Science and Technology , Shenzhen, Guangdong ,","place":["People\u2019s Republic of China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ting","family":"Wang","sequence":"additional","affiliation":[{"name":"Yicura BioMed Limited, Hong Kong SAR ,","place":["People\u2019s Republic of China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanhua","family":"Du","sequence":"additional","affiliation":[{"name":"Yicura BioMed Limited, Hong Kong SAR ,","place":["People\u2019s Republic of China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2569-3048","authenticated-orcid":false,"given":"Xiaoyun","family":"Yang","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Respiratory Disease & National Clinical Research Centre for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou Medical University, Guangzhou Laboratory , Guangzhou ,","place":["People\u2019s Republic of China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3236-5170","authenticated-orcid":false,"given":"Zhongfang","family":"Wang","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Respiratory Disease & National Clinical Research Centre for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou Medical University, Guangzhou Laboratory , Guangzhou ,","place":["People\u2019s Republic of China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Wang","sequence":"additional","affiliation":[{"name":"National Clinical Research Centre for Infectious Diseases and Shenzhen Clinical Research Centre for Infectious Diseases, State Key Discipline of Infectious Disease, Shenzhen Third People\u2019s Hospital, Second Affiliated Hospital of Southern University of Science and Technology , Shenzhen, Guangdong ,","place":["People\u2019s 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