Immunogenicity and safety following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine with Matrix-M <sup>TM</sup> adjuvant (NVX-CoV2373) versus a primary series in people living with and without HIV-1 infection in South Afri

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, MN<sub>50</sub> 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. The safety profile was similar among the pre-crossover/booster phase groups; solicited and unsolicited adverse events were infrequent in all groups. A single NVX-CoV2373 booster dose substantially increased antibodies. All baseline seropositive participants showed higher immune responses than seronegative participants. These findings support use of NVX-CoV2373, including in immunocompromised individuals.

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Publication Details

Journal
Human Vaccines & Immunotherapeutics
Published
2024-12-12
DOI
https://doi.org/10.1080/21645515.2024.2425147
Citations
3
Primary Topic
SARS-CoV-2 and COVID-19 Research
Type
article
Field-Weighted Citation Impact
1.17

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article

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 Afri

Aliasgar Esmail, Greg Glenn, Louis Fries, Dishiki Kalonji et al.
3 citations
Human Vaccines & Immunotherapeutics
SARS-CoV-2 and COVID-19 Research
1.17
article

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 Afri

Aliasgar Esmail, Greg Glenn, Louis Fries, Dishiki Kalonji, As’ad E. Bhorat, Joyce S. Plested, Johan Lombaard, Dhayendre Moodley, Iksung Cho, Leon Fouche, Nishanta Singh, Aylin Jose, Pieter-Louis Vollgraaff, Anthonet Koen, Ameena Goga, Sherika Hanley, Michèle Tameris, Asha Thombrayil, Mduduzi Masilela, Susan Neal, Qasim Bhorat, Chijioke Bennett, Zaheer Hoosain, Gabriella Benadé, Keertan Dheda, Umesh Lalloo, Friedrich G. Petrick, Natasha Lalloo, Shabir Ahmed Madhi, Khatija Ahmed, Angelique Kany Kany Luabeya, Natasha Joseph, Coert Grobbelaar, Alex Marcheschi, Shane Cloney-Clark, Moherndran Archary, Gary Albert, Lee Fairlie, Rosie Mngqibisa, Mingzhu Zhu, Vivek Shinde, Sharne Foulkes, Cheryl Louw, Gordon Chau, Anna Pitsi
article en
3 citations

Abstract

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, MN<sub>50</sub> 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. The safety profile was similar among the pre-crossover/booster phase groups; solicited and unsolicited adverse events were infrequent in all groups. A single NVX-CoV2373 booster dose substantially increased antibodies. All baseline seropositive participants showed higher immune responses than seronegative participants. These findings support use of NVX-CoV2373, including in immunocompromised individuals.

Human Vaccines & ImmunotherapeuticsVol. 20(1)
Mercer (Czechia) (CZ), South African Medical Research Council (ZA), University of Cape Town (ZA), University of Jos (NG), University of the Witwatersrand (ZA), Centre for the AIDS Programme of Research in South Africa (ZA), Novavax (United States) (US), South African Tuberculosis Vaccine Initiative (ZA), Aurum Institute (ZA), Soweto CTC (ZA), Mercy Research (US), Setshaba Research Centre (ZA), Research Research (South Africa) (ZA), Pemex (Mexico) (MX), University of Pretoria (ZA), University of Limpopo (ZA), University of KwaZulu-Natal (ZA)
Bill and Melinda Gates Foundation, GlaxoSmithKline, Novavax, Coalition for Epidemic Preparedness Innovations, Materials and Energy Research Center
Good health and well-being
Openalex Percentile: Top 20%
SARS-CoV-2 and COVID-19 Research
1.17
DOIOpen Access PDFOpenAlex
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