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HepB-CpG vs HepB-Alum Vaccine in People With HIV and Prior Vaccine Nonresponse

医学 乙型肝炎表面抗原 佐剂 乙肝疫苗 接种疫苗 养生 乙型肝炎 乙型肝炎病毒 内科学 免疫学 病毒学 病毒
作者
Kristen Marks,Minhee Kang,Triin Umbleja,Andrea L. Cox,Karen J. Vigil,Nasyrina Ta,Ayotunde Omoz-Oarhe,Hugo Perazzo,Josphat Kosgei,Timothy Hatlen,Jennifer C. Price,Leolin Katsidzira,Khuanchai Supparatpinyo,Kevin Knowles,Beverly Alston‐Smith,P. N. Rathod,Kenneth E. Sherman,Oladapo Alli,Ceora Beijer,Stephanie Caruso,Shawn Chiambah,Lillian Collins,Kim Epperson,Françoise Giguel,Jan Kosmyna,Michael Leonard,Terence Mohammed,Leonard Sowah,Christina Vernon,Sara Zabih,Katrina Shea,M. Gustave Planchon,Paul E. Sax,Cheryl Keenan,Joyce Jones,Alex Hessel,Aleen Khodabakhshian,L. Lawrence Mark,Eric S. Daar,Ruben Lopez,Rosemarie Ramirez,Dawn Rosenblum,Dennis Dentoni-Lasofsky,Cecilia Elizabeth Ceron Alfaro,Madhu Choudhary,Jen Sullivano,Rachel Bender Ignacio,Ellen L. Burnham,Teresa Spitz,Raghd Alyatim,Susan L. Koletar,Robyn Cicarella,Carl J. Fichtenbaum,Michelle Saemann,Leila Hojat,Brenda Brown,Vivek Daniel Paul,Claudia Hawkins,Jaclyn Leone,Jonathan Oakes,Cornelius Van Dam,Kelly‐Anne Phillips,Tracey Watkins,Ericka Patrick,Clifford Gunthel,Joslyn Axinn,Nicola Haakonsen,William R. Short,Pablo Tebas,Keisha Ballentine-Cargill,Nahid Islam,Daniel K. Finn,Carmen Jerry,Sharlaa Badal‐Faesen,Iveshni Govender,Penelope Madlala,Rosie Mngqibisa,Nathália Soliva,Tonia Magali Moraes BRUM,Breno Santos,Rita de Cássia Alves Lira,Lerato Mohapi,Noemi Marengo,Sandra Rwambuya,Francis Ssali,Josphat Kosgei,Geoffrey Koskei,Ditlamelo Mareme,Boitshepho Seme,Mulinda Nyirenda,Maxwell Yohane,Michael T. Yin,Anyelina Cantos,Karen J. Vigil,Mariano J. Lodigiani,Patcharaphan Sugandhavesa,Daralak Tavornprasit,Shobha Swaminathan,Christie Lyn Costanza,Sonal S. Munsiff,Susan E. Hulse,Sonya L. Heath,Edgar T. Overton,Megan Elizabeth Dieterich,Carrington Koebele,Anchalee Avihingsanon,Hay Mar Su Lwin,Maria Tarcela Gler,Miguel A. Frias,Ngan Ta Thi Dieu,Dat Quoc Vu
出处
期刊:JAMA [American Medical Association]
标识
DOI:10.1001/jama.2024.24490
摘要

Importance Nonresponse to hepatitis B vaccine is common among people with HIV, resulting in vulnerability to infection with hepatitis B virus (HBV). Objective 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. Design, Setting, and Participants This phase 3, open-label, randomized clinical trial included people with HIV receiving antiretroviral therapy (CD4 cell count ≥100 cells/μL and HIV RNA <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. Interventions 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. Main Outcomes and Measures The primary outcome was a seroprotection response to hepatitis B vaccine (defined as level of antibody titer against hepatitis B surface antigen [HBsAg] ≥10 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. Results 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 = 174), in 99.4% who received 3 doses of HepB-CpG vaccine (n = 169), and in 80.6% who received 3 doses of HepB-alum vaccine (n = 165). 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. Conclusions and Relevance 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. Trial Registration ClinicalTrials.gov Identifier: NCT04193189
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