dc.contributor.author |
Shinde, Vivek
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dc.contributor.author |
Bhikha, Sutika
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dc.contributor.author |
Hoosain, Zaheer
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dc.contributor.author |
Archary, Moherndran
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dc.contributor.author |
Bhorat, Qasim
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dc.contributor.author |
Fairlie, Lee
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dc.contributor.author |
Lalloo, Umesh G.
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dc.contributor.author |
Mduduzi, S.L.
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dc.contributor.author |
Masilela, M.B.
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dc.contributor.author |
Moodley, Dhayendre
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dc.contributor.author |
Hanley, Sherika
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dc.contributor.author |
Fouche, Leon
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dc.contributor.author |
Louw, Cheryl
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dc.contributor.author |
Tameris, Michele
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dc.contributor.author |
Singh, Nishanta
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dc.contributor.author |
Goga, Ameena Ebrahim
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dc.contributor.author |
Dheda, Keertan
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dc.contributor.author |
Kruger, Gertruida
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dc.contributor.author |
Carrim‑Ganey, Nazira
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dc.contributor.author |
Baillie, Vicky
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dc.contributor.author |
De Oliveira, Tulio
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dc.contributor.author |
Koen, Anthonet Lombard
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dc.contributor.author |
Lombaard, Johan J.
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dc.contributor.author |
Mngqibisa, Rosie
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dc.contributor.author |
Bhorat, As’ad E.
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dc.contributor.author |
Benade, Gabriella
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dc.contributor.author |
Lalloo, Natasha
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dc.contributor.author |
Pitsi, Annah
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dc.contributor.author |
Vollgraaff, Pieter‑Louis
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dc.contributor.author |
Luabeya, Angelique
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dc.contributor.author |
Esmail, Aliasgar
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dc.contributor.author |
Petrick, Friedrich G.
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dc.contributor.author |
Oommen‑Jose, Aylin
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dc.contributor.author |
Foulkes, Sharne
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dc.contributor.author |
Ahmed, Khatija
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dc.contributor.author |
Thombrayil, Asha
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dc.contributor.author |
Fries, Lou
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dc.contributor.author |
Cloney‑Clark, Shane
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dc.contributor.author |
Zhu, Mingzhu
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dc.contributor.author |
Bennett, Chijioke
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dc.contributor.author |
Albert, Gary
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dc.contributor.author |
Faust, Emmanuel
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dc.contributor.author |
Plested, Joyce S.
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dc.contributor.author |
Robertson, Andreana
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dc.contributor.author |
Neal, Susan
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dc.contributor.author |
Cho, Iksung
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dc.contributor.author |
Glenn, Greg M.
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dc.contributor.author |
Dubovsky, Filip
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dc.contributor.author |
Madhi, Shabir A.
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dc.date.accessioned |
2022-11-01T13:08:45Z |
|
dc.date.available |
2022-11-01T13:08:45Z |
|
dc.date.issued |
2021-05-05 |
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dc.description.abstract |
BACKGROUND : The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control of the coronavirus disease 2019 (Covid-19) pandemic. In a phase 1–2 trial involving healthy adults, the NVXCoV2373 nanoparticle vaccine had an acceptable safety profile and was associated with strong neutralizing-antibody and antigen-specific polyfunctional CD4+ T-cell responses. Evaluation of vaccine efficacy was needed in a setting of ongoing SARSCoV- 2 transmission. METHODS : In this phase 2a–b trial in South Africa, we randomly assigned human immunodeficiency virus (HIV)–negative adults between the ages of 18 and 84 years or medically stable HIV-positive participants between the ages of 18 and 64 years in a 1:1 ratio to receive two doses of either the NVX-CoV2373 vaccine (5 μg of recombinant spike protein with 50 μg of Matrix-M1 adjuvant) or placebo. The primary end points were safety and vaccine efficacy against laboratory-confirmed symptomatic Covid-19 at 7 days or more after the second dose among participants without previous SARS-CoV-2 infection. RESULTS : Of 6324 participants who underwent screening, 4387 received at least one injection of vaccine or placebo. Approximately 30% of the participants were seropositive for SARS-CoV-2 at baseline. Among 2684 baseline seronegative participants (94% HIV-negative and 6% HIV-positive), predominantly mild-to-moderate Covid-19 developed in 15 participants in the vaccine group and in 29 in the placebo group (vaccine efficacy, 49.4%; 95% confidence interval [CI], 6.1 to 72.8). Vaccine efficacy among HIV-negative participants was 60.1% (95% CI, 19.9 to 80.1). Of 41 sequenced isolates, 38 (92.7%) were the B.1.351 variant. Post hoc vaccine efficacy against B.1.351 was 51.0% (95% CI, −0.6 to 76.2) among the HIV-negative participants. Preliminary local and systemic reactogenicity events were more common in the vaccine group; serious adverse events were rare in both groups. CONCLUSIONS : The NVX-CoV2373 vaccine was efficacious in preventing Covid-19, with higher vaccine efficacy observed among HIV-negative participants. Most infections were caused by the B.1.351 variant. |
en_US |
dc.description.department |
Family Medicine |
en_US |
dc.description.department |
School of Health Systems and Public Health (SHSPH) |
en_US |
dc.description.librarian |
am2022 |
en_US |
dc.description.sponsorship |
Novavax and the Bill and Melinda Gates Foundation. |
en_US |
dc.description.uri |
http://www.nejm.org |
en_US |
dc.identifier.citation |
Shinde, V, Bhikha, Z., Hoosain, Z. et al. 2021, 'Efficacy of NVX-CoV2373 covid-19 vaccine against the B.1.351 variant', New England Journal of Medicine, vol. 384, no. 20, pp. 1899-1909, doi : 10.1056/NEJMoa2103055. |
en_US |
dc.identifier.issn |
0028-4793 (print) |
|
dc.identifier.issn |
1533-4406 (online) |
|
dc.identifier.other |
10.1056/NEJMoa2103055 |
|
dc.identifier.uri |
https://repository.up.ac.za/handle/2263/88064 |
|
dc.language.iso |
en |
en_US |
dc.publisher |
Massachusetts Medical Society |
en_US |
dc.rights |
© 2021 Massachusetts Medical Society. |
en_US |
dc.subject |
NVX-CoV2373 vaccine |
en_US |
dc.subject |
HIV-negative |
en_US |
dc.subject |
Infections |
en_US |
dc.subject |
B.1.351 variant |
en_US |
dc.subject |
Human immunodeficiency virus (HIV) |
en_US |
dc.subject |
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) |
en_US |
dc.subject |
COVID-19 pandemic |
en_US |
dc.subject |
Coronavirus disease 2019 (COVID-19) |
en_US |
dc.title |
Efficacy of NVX-CoV2373 COVID-19 vaccine against the B.1.351 variant |
en_US |
dc.type |
Article |
en_US |