{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T00:37:31Z","timestamp":1793147851302,"version":"4.5.0"},"reference-count":18,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2025,1,28]]},"abstract":"Importance<\/jats:title>Nonresponse to hepatitis B vaccine is common among people with HIV, resulting in vulnerability to infection with hepatitis B virus (HBV).<\/jats:p><\/jats:sec>Objective<\/jats:title>To compare the seroprotection response achieved with a 2-dose (noninferiority, 10% margin) and a 3-dose hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG vaccine) vs a conventional 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant (HepB-alum vaccine) in people with HIV and prior nonresponse to HepB-alum vaccine.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This phase 3, open-label, randomized clinical trial included people with HIV receiving antiretroviral therapy (CD4 cell count \u2265100 cells\/\u03bcL and HIV RNA &amp;lt;1000 copies\/mL) without past or present serological evidence of having HBV or a response to hepatitis B vaccine. From December 2020 to February 2023, 561 adults were enrolled in the study at 41 sites in 10 countries in Africa, Asia, North America, and South America with follow-up for the primary outcome analysis through September 4, 2023.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Participants were randomly assigned to receive 2 doses of HepB-CpG vaccine administered intramuscularly at weeks 0 and 4; 3 doses of HepB-CpG vaccine administered intramuscularly at weeks 0, 4, and 24; or 3 doses of HepB-alum vaccine administered intramuscularly at weeks 0, 4, and 24.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The primary outcome was a seroprotection response to hepatitis B vaccine (defined as level of antibody titer against hepatitis B surface antigen [HBsAg] \u226510 mIU\/mL) at week 12 for the 2-dose regimen (8 weeks after dose 2) and at week 28 for 3-dose regimens (4 weeks after dose 3). Key secondary outcomes included seroprotection response at additional time points, antibody titer against HBsAg, and adverse events within 4 weeks of hepatitis B vaccination.<\/jats:p><\/jats:sec>Results<\/jats:title>Of 561 participants included in the analysis (median age, 46 years [IQR, 31-56 years]); 64% were male; 17% of participants were Asian, 42% were Black, and 35% were White), a seroprotection response was achieved in 93.1% who received 2 doses of HepB-CpG vaccine (n\u2009=\u2009174), in 99.4% who received 3 doses of HepB-CpG vaccine (n\u2009=\u2009169), and in 80.6% who received 3 doses of HepB-alum vaccine (n\u2009=\u2009165). The stratified difference in seroprotection response between the 2-dose HepB-CpG vaccine group and the 3-dose HepB-alum vaccine group was 12.5% (97.5% CI, 4.1%-20.9%), achieving noninferiority and indicating superiority. The 3-dose HepB-CpG vaccine regimen was superior to the 3-dose HepB-alum vaccine regimen (stratified difference in seroprotection response, 18.4% [repeated 97.5% CI, 10.4%-26.2%]). By week 12, more than 90% of participants who received HepB-CpG vaccine achieved a seroprotection response. The 3-dose regimen of HepB-CpG vaccine achieved a higher proportion of participants with antibody titer against HBsAg greater than 1000 mIU\/mL (78.1%) vs the other 2 regimen groups (26.4% for 2 doses of HepB-CpG vaccine and 35.2% for 3 doses of HepB-alum vaccine). No unexpected safety issues were observed.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>Among people with HIV and nonresponse to prior hepatitis B vaccination, both the 2-dose and 3-dose regimens of HepB-CpG vaccine achieved a superior seroprotection response compared with 3 doses of HepB-alum vaccine.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT04193189<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jama.2024.24490","type":"journal-article","created":{"date-parts":[[2024,12,1]],"date-time":"2024-12-01T16:30:55Z","timestamp":1733070655000},"page":"295","source":"Crossref","is-referenced-by-count":57,"title":["HepB-CpG vs HepB-Alum Vaccine in People With HIV and Prior Vaccine Nonresponse"],"prefix":"10.1001","volume":"333","author":[{"given":"Kristen M.","family":"Marks","sequence":"first","affiliation":[{"name":"Weill Cornell Medicine, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minhee","family":"Kang","sequence":"additional","affiliation":[{"name":"T. 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