tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2024 Dec 31;20(1):2425147.
doi: 10.1080/21645515.2024.2425147. Epub 2024 Dec 12. 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 Africa: A randomized crossover phase 2a/2b trial
Vivek Shinde[SUP] 1 [/SUP], Anthonet Lombard Koen[SUP] 2 [/SUP], Zaheer Hoosain[SUP] 3 [/SUP], Moherndran Archary[SUP] 4 [/SUP], Qasim Bhorat[SUP] 5 [/SUP], Lee Fairlie[SUP] 6 [/SUP], Umesh Lalloo[SUP] 7 [/SUP], Mduduzi S L Masilela[SUP] 8 [/SUP], Dhayendre Moodley[SUP] 9 [/SUP], Sherika Hanley[SUP] 10 [/SUP], Leon Frederik Fouche[SUP] 11 [/SUP], Cheryl Louw[SUP] 12 13 [/SUP], Michele Tameris[SUP] 14 [/SUP], Nishanta Singh[SUP] 15 [/SUP], Ameena Goga[SUP] 15 [/SUP], Keertan Dheda[SUP] 16 [/SUP], Coert Grobbelaar[SUP] 17 [/SUP], Natasha Joseph[SUP] 18 [/SUP], Johan J Lombaard[SUP] 3 [/SUP], Rosie Mngqibisa[SUP] 4 [/SUP], As'ad Ebrahim Bhorat[SUP] 5 [/SUP], Gabriella Benadé[SUP] 6 [/SUP], Natasha Lalloo[SUP] 7 [/SUP], Anna Pitsi[SUP] 8 [/SUP], Pieter-Louis Vollgraaff[SUP] 11 [/SUP], Angelique Luabeya[SUP] 14 [/SUP], Aliasgar Esmail[SUP] 16 [/SUP], Friedrich G Petrick[SUP] 19 [/SUP], Aylin Oommen Jose[SUP] 2 [/SUP], Sharne Foulkes[SUP] 3 [/SUP], Khatija Ahmed[SUP] 8 20 [/SUP], Asha Thombrayil[SUP] 2 [/SUP], Dishiki Kalonji[SUP] 2 15 [/SUP], Shane Cloney-Clark[SUP] 1 [/SUP], Mingzhu Zhu[SUP] 1 [/SUP], Chijioke Bennett[SUP] 1 [/SUP], Gary Albert[SUP] 1 [/SUP], Alex Marcheschi[SUP] 1 [/SUP], Joyce S Plested[SUP] 1 [/SUP], Susan Neal[SUP] 1 [/SUP], Gordon Chau[SUP] 1 [/SUP], Iksung Cho[SUP] 1 [/SUP], Louis Fries[SUP] 1 [/SUP], Greg M Glenn[SUP] 1 [/SUP], Shabir A Madhi[SUP] 2 [/SUP]; 2019nCoV-501 Study Group
Affiliations
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.
Keywords: Novavax, Inc.; and the Coalition for Epidemic Preparedness Innovations; the Bill & Melinda Gates Foundation.
. 2024 Dec 31;20(1):2425147.
doi: 10.1080/21645515.2024.2425147. Epub 2024 Dec 12. 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 Africa: A randomized crossover phase 2a/2b trial
Vivek Shinde[SUP] 1 [/SUP], Anthonet Lombard Koen[SUP] 2 [/SUP], Zaheer Hoosain[SUP] 3 [/SUP], Moherndran Archary[SUP] 4 [/SUP], Qasim Bhorat[SUP] 5 [/SUP], Lee Fairlie[SUP] 6 [/SUP], Umesh Lalloo[SUP] 7 [/SUP], Mduduzi S L Masilela[SUP] 8 [/SUP], Dhayendre Moodley[SUP] 9 [/SUP], Sherika Hanley[SUP] 10 [/SUP], Leon Frederik Fouche[SUP] 11 [/SUP], Cheryl Louw[SUP] 12 13 [/SUP], Michele Tameris[SUP] 14 [/SUP], Nishanta Singh[SUP] 15 [/SUP], Ameena Goga[SUP] 15 [/SUP], Keertan Dheda[SUP] 16 [/SUP], Coert Grobbelaar[SUP] 17 [/SUP], Natasha Joseph[SUP] 18 [/SUP], Johan J Lombaard[SUP] 3 [/SUP], Rosie Mngqibisa[SUP] 4 [/SUP], As'ad Ebrahim Bhorat[SUP] 5 [/SUP], Gabriella Benadé[SUP] 6 [/SUP], Natasha Lalloo[SUP] 7 [/SUP], Anna Pitsi[SUP] 8 [/SUP], Pieter-Louis Vollgraaff[SUP] 11 [/SUP], Angelique Luabeya[SUP] 14 [/SUP], Aliasgar Esmail[SUP] 16 [/SUP], Friedrich G Petrick[SUP] 19 [/SUP], Aylin Oommen Jose[SUP] 2 [/SUP], Sharne Foulkes[SUP] 3 [/SUP], Khatija Ahmed[SUP] 8 20 [/SUP], Asha Thombrayil[SUP] 2 [/SUP], Dishiki Kalonji[SUP] 2 15 [/SUP], Shane Cloney-Clark[SUP] 1 [/SUP], Mingzhu Zhu[SUP] 1 [/SUP], Chijioke Bennett[SUP] 1 [/SUP], Gary Albert[SUP] 1 [/SUP], Alex Marcheschi[SUP] 1 [/SUP], Joyce S Plested[SUP] 1 [/SUP], Susan Neal[SUP] 1 [/SUP], Gordon Chau[SUP] 1 [/SUP], Iksung Cho[SUP] 1 [/SUP], Louis Fries[SUP] 1 [/SUP], Greg M Glenn[SUP] 1 [/SUP], Shabir A Madhi[SUP] 2 [/SUP]; 2019nCoV-501 Study Group
Affiliations
- PMID: 39666396
- DOI: 10.1080/21645515.2024.2425147
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.
Keywords: Novavax, Inc.; and the Coalition for Epidemic Preparedness Innovations; the Bill & Melinda Gates Foundation.