1. Hybrid versus vaccine immunity of mRNA-1273 among people living with HIV in East and Southern Africa: a prospective cohort analysis from the multicentre CoVPN 3008 (Ubuntu) studyResearch in context
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Nigel Garrett, Asa Tapley, Aaron Hudson, Sufia Dadabhai, Bo Zhang, Nyaradzo M. Mgodi, Jessica Andriesen, Azwidihwi Takalani, Leigh H. Fisher, Jia Jin Kee, Craig A. Magaret, Manuel Villaran, John Hural, Erica Andersen-Nissen, Guido Ferarri, Maurine D. Miner, Bert Le Roux, Eduan Wilkinson, Richard Lessells, Tulio de Oliveira, Jackline Odhiambo, Parth Shah, Laura Polakowski, Margaret Yacovone, Taraz Samandari, Zvavahera Chirenje, Peter James Elyanu, Joseph Makhema, Ethel Kamuti, Harriet Nuwagaba-Biribonwoha, Sharlaa Badal-Faesen, William Brumskine, Soritha Coetzer, Rodney Dawson, Sinead Delany-Moretlwe, Andreas Henri Diacon, Samantha Fry, Katherine Margaret Gill, Zaheer Ahmed Ebrahim Hoosain, Mina C. Hosseinipour, Mubiana Inambao, Craig Innes, Steve Innes, Dishiki Kalonji, Margaret Kasaro, Priya Kassim, Noel Kayange, William Kilembe, Fatima Laher, Moelo Malahleha, Vongane Louisa Maluleke, Grace Mboya, Kirsten McHarry, Essack Mitha, Kathryn Mngadi, Pamela Mda, Tumelo Moloantoa, Cissy Kityo Mutuluuza, Nivashnee Naicker, Vimla Naicker, Anusha Nana, Annet Nanvubya, Maphoshane Nchabeleng, Walter Otieno, Elsje Louise Potgieter, Disebo Potloane, Zelda Punt, Jamil Said, Yashna Singh, Mohammed Siddique Tayob, Yacoob Vahed, Deo Ogema Wabwire, M. Juliana McElrath, James G. Kublin, Linda-Gail Bekker, Peter B. Gilbert, Lawrence Corey, Glenda E. Gray, Yunda Huang, Philip Kotze, Kagisho Baepanye, Veronique Bailey, Katekani Baloyi-Oseh, Mumtaz Booley, Johannes Louis Botha, Yolande Brown, Valerie Brown, Lisa Bunts, Myron Cohen, Shirley Collie, Pallabi Deb, Hana El Sahly, Jill El-Khorazaty, Andries Engelbrecht, Marianne Gildea, Dhevium Govender, Jen Hanke, Jayla Harris, Simone Hendricks, Nick Hopkinson, Haley Howell, Nzeera Ketter, Kentse Khuto, Faatima Laher Omar, Leolin Katsidzira, Kim Linton, James Ludwig, Bongile Mabilane, Matshidiso Malefo, Ndiitwani Mamushiana, Daciana Margineantu, Jeanine May, Fatima Mayat, Cindy Molitor, Yeshnee Naidoo, Michelle Nebergall, Alan Nguyen, Sarah Nikles, Bianca Noronha, Melissa Peda, Tamara Phiri, Shanthie Pillay, Sureshnee Pillay, Lori Proulx-Burns, Laurie Rinn, Lisa Sanders, Carrie Sopher, Smitha Sripathy, Michael Stirewalt, Houriiyah Tegally, Sara Thiebaud, Alicia Toledano, Stephanie Van Wyk, Shamaya Whitby, Stephany Wilcox, Haven Wilvich, Charles Wiysonge, Nelisiwe Xaba, and Ntokozo Xulu
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People living with HIV ,SARS-CoV-2 ,mRNA-1273 ,Hybrid immunity ,Vaccine immunity ,COVID-19 ,Medicine (General) ,R5-920 - Abstract
Summary: Background: With limited access to mRNA COVID-19 vaccines in lower income countries, and people living with HIV (PLWH) largely excluded from clinical trials, Part A of the multicentre CoVPN 3008 (Ubuntu) study aimed to assess the safety of mRNA-1273, the relative effectiveness of hybrid versus vaccine immunity, and SARS-CoV-2 viral persistence among PLWH in East and Southern Africa during the omicron outbreak. Methods: Previously unvaccinated adults with HIV and/or other comorbidities associated with severe COVID-19 received either one (hybrid immunity) or two (vaccine immunity) 100-mcg doses of ancestral strain mRNA-1273 in the first month, depending on baseline evidence of prior SARS-CoV-2 infection. In a prospective cohort study design, we used covariate-adjusted Cox regression and counterfactual cumulative incidence methods to determine the hazard ratio and relative risk of COVID-19 and severe COVID-19 with hybrid versus vaccine immunity within six months. The ongoing Ubuntu study is registered on ClinicalTrials.gov (NCT05168813) and this work was conducted from December 2021 to March 2023. Findings: Between December 2021 and September 2022, 14,237 participants enrolled, and 14,002 (83% PLWH, 69% SARS-CoV-2 seropositive) were included in the analyses. Vaccinations were safe and well tolerated. Common adverse events were pain or tenderness at the injection site (26.7%), headache (20.4%), and malaise (20.3%). Severe adverse events were rare (0.8% of participants after the first and 1.1% after the second vaccination), and none were life-threatening or fatal. Among PLWH, the median CD4 count was 635 cells/μl and 18.5% had HIV viraemia. The six-month cumulative incidences in the hybrid immunity and vaccine immunity groups were 2.02% (95% confidence interval [CI] 1.61–2.44) and 3.40% (95% CI 2.30–4.49) for COVID-19, and 0.048% (95% CI 0.00–0.10) and 0.32% (95% CI 0.59–0.63) for severe COVID-19. Among all PLWH the hybrid immunity group had a 42% lower hazard rate of COVID-19 (hazard ratio [HR] 0.58; 95% CI 0.44–0.77; p
- Published
- 2025
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