Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.351 Variant

BACKGROUND: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control of the Covid-19 pandemic. Evaluation of Covid-19 vaccine efficacy against SARS-CoV-2 variants is urgently needed to inform vaccine development and use. METHODS: In thi...

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Detalles Bibliográficos
Autores principales: Shinde, Vivek, Bhikha, Sutika, Hoosain, Zaheer, Archary, Moherndran, Bhorat, Qasim, Fairlie, Lee, Lalloo, Umesh, Masilela, Mduduzi S. L., Moodley, Dhayendre, Hanley, Sherika, Fouche, Leon, Louw, Cheryl, Tameris, Michele, Singh, Nishanta, Goga, Ameena, Dheda, Keertan, Grobbelaar, Coert, Kruger, Gertruida, Carrim-Ganey, Nazira, Baillie, Vicky, de Oliveira, Tulio, Koen, Anthonet Lombard, Lombaard, Johan J., Mngqibisa, Rosie, Bhorat, As’ad Ebrahim, Benadé, Gabriella, Lalloo, Natasha, Pitsi, Annah, Vollgraaff, Pieter-Louis, Luabeya, Angelique, Esmail, Aliasgar, Petrick, Friedrich G., Jose, Aylin Oommen, Foulkes, Sharne, Ahmed, Khatija, Thombrayil, Asha, Fries, Lou, Cloney-Clark, Shane, Zhu, Mingzhu, Bennett, Chijioke, Albert, Gary, Faust, Emmanuel, Plested, Joyce S., Robertson, Andreana, Neal, Susan, Cho, Iksung, Glenn, Greg M., Dubovsky, Filip, Madhi, Shabir A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Massachusetts Medical Society 2021
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091623/
https://www.ncbi.nlm.nih.gov/pubmed/33951374
http://dx.doi.org/10.1056/NEJMoa2103055
Descripción
Sumario:BACKGROUND: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control of the Covid-19 pandemic. Evaluation of Covid-19 vaccine efficacy against SARS-CoV-2 variants is urgently needed to inform vaccine development and use. METHODS: In this phase 2a/b, multicenter, randomized, observer-blinded, placebo-controlled trial in South Africa, healthy human immunodeficiency virus (HIV)-negative adults (18 to 84 years) or medically stable people living with HIV (PLWH) (18 to 84 years) were randomized in a 1:1 ratio to receive two doses, administered 21 days apart, of either NVX-CoV2373 nanoparticle vaccine (5 μg recombinant spike protein with 50 μg Matrix-M1 adjuvant) or placebo. The primary endpoints were safety and vaccine efficacy ≥7 days following the second dose against laboratory-confirmed symptomatic Covid-19 in previously SARS-CoV-2 uninfected participants. RESULTS: A total of 4387 participants were randomized and dosed at least once, 2199 with NVX-CoV2373 and 2188 with placebo. Approximately 30% of participants were seropositive at baseline. Among 2684 baseline seronegative participants (94% HIV-negative; 6% PLWH), 15 and 29 predominantly mild to moderate Covid-19 cases were noted in NVX-CoV2373 and placebo recipients, respectively; vaccine efficacy was 49.4% (95% confidence interval [CI]: 6.1 to 72.8). Efficacy in HIV-negative participants was 60.1% (95% CI: 19.9 to 80.1) and did not differ by baseline serostatus; 38 (92.7%) of 41 sequenced cases were the B.1.351 variant. Post-hoc vaccine efficacy against B.1.351 was 51.0% (95% CI: −0.6 to 76.2) in HIV-negative participants. Preliminary local and systemic reactogenicity were primarily mild to moderate and transient, and higher with NVX-CoV2373; serious adverse events were rare in both groups. CONCLUSIONS: The NVX-CoV2373 vaccine was efficacious in preventing Covid-19, which was predominantly mild to moderate and due to the B.1.351 variant.

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