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Immunogenicity and safety following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine with Matrix-MTM 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

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Title: Immunogenicity and safety following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine with Matrix-MTM 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
Authors: Vivek Shinde, Anthonet Lombard Koen, Zaheer Hoosain, Moherndran Archary, Qasim Bhorat, Lee Fairlie, Umesh Lalloo, Mduduzi S. L. Masilela, Dhayendre Moodley, Sherika Hanley, Leon Frederik Fouche, Cheryl Louw, Michele Tameris, Nishanta Singh, Ameena Goga, Keertan Dheda, Coert Grobbelaar, Natasha Joseph, Johan J. Lombaard, Rosie Mngqibisa, As’ad Ebrahim Bhorat, Gabriella Benadé, Natasha Lalloo, Anna Pitsi, Pieter-Louis Vollgraaff, Angelique Luabeya, Aliasgar Esmail, Friedrich G. Petrick, Aylin Oommen 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 M. Glenn, Shabir A. Madhi
Source: Human Vaccines & Immunotherapeutics, Vol 20, Iss 1 (2024)
Publisher Information: Taylor & Francis Group, 2024.
Publication Year: 2024
Collection: LCC:Immunologic diseases. Allergy
LCC:Therapeutics. Pharmacology
Subject Terms: Novavax, Inc., the Bill & Melinda Gates Foundation, and the Coalition for Epidemic Preparedness Innovations, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950
More Details: 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. 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.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 21645515
2164-554X
2164-5515
Relation: https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X
DOI: 10.1080/21645515.2024.2425147
Access URL: https://doaj.org/article/90d0e4a6be6e439a95268e85ec023ca2
Accession Number: edsdoj.90d0e4a6be6e439a95268e85ec023ca2
Database: Directory of Open Access Journals
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  Data: Immunogenicity and safety following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine with Matrix-MTM 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
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  Data: 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. 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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