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<p>People with HIV (PWH) are understudied in COVID-19 vaccine trials, leaving knowledge gaps on whether the identified immune correlates of protection also hold in PWH. CoVPN 3008 (NCT05168813) enrolled predominantly PWH and reported lower COVID-19 incidence for a Hybrid vs. Vaccine Group (baseline SARS-CoV-2-positive and one mRNA-1273 dose vs. negative and two doses). Using case-cohort sampling, antibody markers at enrolment (M0) and four weeks post-final vaccination (Peak) are assessed as immune correlates of COVID-19. For the Hybrid Group [<i>n</i> = 287 (195 PWH)], all M0 markers inversely correlate with COVID-19 through 230 days post-Peak, with 50% inhibitory dilution BA.4/5 neutralizing antibody titer (nAb-ID50 BA.4/5) the strongest and only independent correlate (HR per 10-fold increase=0.46, 95% CI 0.28, 0.75; <i>P</i> = 0.002). For the Vaccine Group [<i>n</i> = 115 (86 PWH)], Peak nAb-ID50 BA.4/5 correlates with reduced COVID-19 risk (1.9%, 1.1%, and 0.3% at titers 10, 100, and 1000 AU/ml) through 92, but not 165, days post-Peak. Using multivariable Cox analysis of binding and nAb, nAb titers predict COVID-19 in PWH. Two doses of a 100-µg Ancestral strain mRNA vaccine in baseline-SARS-CoV-2-negative individuals elicit sufficient cross-reacting Omicron antibodies to reduce COVID-19 incidence for 90 days post-Peak, but viral evolution and waning antibodies abrogate this protection thereafter.</p>

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Neutralizing and binding antibodies are a correlate of risk of COVID-19 in the CoVPN 3008 study in people with HIV

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  • 发表日期：

    2025年10月6日

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  • Nonhlanhla N. Mkhize,
  • Bo Zhang,
  • Caroline Brackett,
  • Peter James Elyanu,
  • Asa Tapley,
  • Sufia Dadabhai,
  • Jiani Hu,
  • Bich T. N. Do,
  • Daniel J. Schuster,
  • Jack Heptinstall,
  • Sheetal Sawant,
  • Kelly Seaton,
  • Marcella Sarzotti-Kelsoe,
  • Aaron Hudson,
  • Yutong Jin,
  • Sinethemba Bhebhe,
  • Haajira Kaldine,
  • Prudence Kgagudi,
  • Tandile Modise,
  • Nyaradzo M. Mgodi,
  • Jessica Andriesen,
  • April K. Randhawa,
  • Leigh H. Fisher,
  • Jia Jin Kee,
  • Craig A. Magaret,
  • James Peng,
  • Avi Kenny,
  • Lindsay N. Carpp,
  • Zhe Chen,
  • Siyu Heng,
  • Manuel Villaran,
  • Azwidihwi Takalani,
  • Bert Le Roux,
  • Eduan Wilkinson,
  • Jackline Odhiambo,
  • Parth Shah,
  • Laura Polakowski,
  • Margaret Yacovone,
  • Taraz Samandari,
  • Zvavahera Chirenje,
  • Joseph Makhema,
  • Ethel Kamuti,
  • Katanekwa Njekwa,
  • Harriet Nuwagaba-Biribonwoha,
  • Allan Baguma,
  • Sharlaa Badal-Faesen,
  • William Brumskine,
  • Soritha Coetzer,
  • Rodney Dawson,
  • Sinead Delany-Moretlwe,
  • Andreas Henri Diacon,
  • Samantha Fry,
  • Katherine Gill,
  • Anda Madikida,
  • Zaheer Ahmed Ebrahim Hoosain,
  • Mina C. Hosseinipour,
  • Mubiana Inambao,
  • Craig Innes,
  • Steve Innes,
  • Dishiki Kalonji,
  • Humphrey Mwape,
  • Priya Kassim,
  • Melvin C. Kamanga,
  • William Kilembe,
  • Fatima Laher,
  • Mookho Malahleha,
  • Vongane Louisa Maluleke,
  • Grace Mboya,
  • Philister Adhiambo Madiega,
  • Kirsten McHarry,
  • Essack Mitha,
  • Yajna Duki,
  • Pamela Mda,
  • Moroesi Moerane,
  • Tumelo Moloantoa,
  • Simpson Nuwamanya,
  • Sharana Mahomed,
  • Vimla Naicker,
  • Anusha Nana,
  • Annet Nanvubya,
  • Barbarah Kawoozo,
  • Maphoshane Nchabeleng,
  • Walter Otieno,
  • Elsje Louise Potgieter,
  • Disebo Potloane,
  • Zelda Punt,
  • Jamil Said,
  • Yashna Singh,
  • Sheetal Kassim,
  • Dorothie van der Vendt,
  • Mohammed Siddique Tayob,
  • Yacoob Vahed,
  • Deo Ogema Wabwire,
  • James G. Kublin,
  • Linda-Gail Bekker,
  • Lawrence Corey,
  • Glenda E. Gray,
  • Yunda Huang,
  • Philip Kotze,
  • Nigel Garrett,
  • John Hural,
  • Guido Ferrari,
  • Erica Andersen-Nissen,
  • David Montefiori,
  • Penny L. Moore,
  • M. Juliana McElrath,
  • Georgia D. Tomaras,
  • Peter B. Gilbert

摘要

People with HIV (PWH) are understudied in COVID-19 vaccine trials, leaving knowledge gaps on whether the identified immune correlates of protection also hold in PWH. CoVPN 3008 (NCT05168813) enrolled predominantly PWH and reported lower COVID-19 incidence for a Hybrid vs. Vaccine Group (baseline SARS-CoV-2-positive and one mRNA-1273 dose vs. negative and two doses). Using case-cohort sampling, antibody markers at enrolment (M0) and four weeks post-final vaccination (Peak) are assessed as immune correlates of COVID-19. For the Hybrid Group [n = 287 (195 PWH)], all M0 markers inversely correlate with COVID-19 through 230 days post-Peak, with 50% inhibitory dilution BA.4/5 neutralizing antibody titer (nAb-ID50 BA.4/5) the strongest and only independent correlate (HR per 10-fold increase=0.46, 95% CI 0.28, 0.75; P = 0.002). For the Vaccine Group [n = 115 (86 PWH)], Peak nAb-ID50 BA.4/5 correlates with reduced COVID-19 risk (1.9%, 1.1%, and 0.3% at titers 10, 100, and 1000 AU/ml) through 92, but not 165, days post-Peak. Using multivariable Cox analysis of binding and nAb, nAb titers predict COVID-19 in PWH. Two doses of a 100-µg Ancestral strain mRNA vaccine in baseline-SARS-CoV-2-negative individuals elicit sufficient cross-reacting Omicron antibodies to reduce COVID-19 incidence for 90 days post-Peak, but viral evolution and waning antibodies abrogate this protection thereafter.