Immunogenicity and safety following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine with Matrix-M TM adjuvant (NVX-CoV2373) versus a primary series in people living with and without HIV-1 infection in South Africa: A randomized crossover phase 2a/2b trial

作者：Vivek Shinde, Anthonet Koen, Zaheer Hoosain, Moherndran Archary, Qasim Bhorat, Lee Fairlie, Umesh Lalloo, Mduduzi Masilela, Dhayendre Moodley, Sherika Hanley, Leon Fouche, Cheryl Louw, Michèle Tameris, Nishanta Singh, Ameena Goga, Keertan Dheda, Coert Grobbelaar, Natasha Joseph, Johan Lombaard, Rosie Mngqibisa, As’ad E. Bhorat, Gabriella Benadé, Natasha Lalloo, Anna Pitsi, Pieter-Louis Vollgraaff, Angelique Kany Kany Luabeya, Aliasgar Esmail, Friedrich G. Petrick, Aylin Jose, Sharne Foulkes, Khatija Ahmed, Asha Thombrayil, Dishiki Kalonji, Shane Cloney-Clark, Mingzhu Zhu, Chijioke Bennett, Gary Albert, Alex Marcheschi, Joyce S. Plested, Susan Neal, Gordon Chau, Iksung Cho, Louis Fries, Greg Glenn, Shabir A. Madhi, for the 2019nCoV-501 Study Group · 发表于：Human Vaccines & Immunotherapeutics · 年份：2024 · DOI：10.1080/21645515.2024.2425147 · 被引用次数：3 · 研究领域：SARS-CoV-2 and COVID-19 Research、Vaccine Coverage and Hesitancy、COVID-19 Clinical Research Studies

COVID-19 remains a global public health issue and an improved understanding of vaccine performance in immunocompromised individuals, including people living with HIV (PLWH), is needed. Initial data from the present study’s pre-crossover/booster phase were previously reported. This phase 2a/b clinical trial in South Africa (2019nCoV-501/NCT04533399) revisits 1:1 randomly assigned HIV-negative adults (18–84 years) and medically stable PLWH (18–64 years) who previously received two NVX-CoV2373 doses (5 μg recombinant Spike protein with 50 μg Matrix-M™ adjuvant) or placebo. During the 6-month blinded crossover/booster phase, NVX-CoV2373 recipients could receive a single NVX-CoV2373 booster dose and placebo recipients a 2-dose NVX-CoV2373 primary series. NVX-CoV2373 safety and immunogenicity were assessed according to prior SARS-CoV-2 infection and HIV status. Post-crossover, 1900/3793 NVX-CoV2373 recipients were assigned another dose, and 1893/3793 placebo recipients were assigned NVX-CoV2373 primary series. Approximately 56% of the participants were SARS-CoV-2–seropositive (“seropositive”) at crossover (6% PLWH). In seropositive participants (HIV-negative and PLWH), booster-dose anti-spike IgG, MN50 and hACE2 inhibition responses increased to similar levels, exceeding those in seronegative participants. In primary-series and booster cohorts, seronegative PLWH showed higher neutralizing responses (4.9- to 5.5-fold, respectively) versus peak pre-crossover primary-series responses....