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Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine.
Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, Plested JS, Zhu M, Cloney-Clark S, Zhou H, Smith G, Patel N, Frieman MB, Haupt RE, Logue J, McGrath M, Weston S, Piedra PA, Desai C, Callahan K, Lewis M, Price-Abbott P, Formica N, Shinde V, Fries L, Lickliter JD, Griffin P, Wilkinson B, Glenn GM. Keech C, et al. Among authors: zhu m. N Engl J Med. 2020 Dec 10;383(24):2320-2332. doi: 10.1056/NEJMoa2026920. Epub 2020 Sep 2. N Engl J Med. 2020. PMID: 32877576 Free PMC article. Clinical Trial.
Induction of Cross-Reactive Hemagglutination Inhibiting Antibody and Polyfunctional CD4+ T-Cell Responses by a Recombinant Matrix-M-Adjuvanted Hemagglutinin Nanoparticle Influenza Vaccine.
Shinde V, Cai R, Plested J, Cho I, Fiske J, Pham X, Zhu M, Cloney-Clark S, Wang N, Zhou H, Zhou B, Patel N, Massare MJ, Fix A, Spindler M, Thomas DN, Smith G, Fries L, Glenn GM. Shinde V, et al. Among authors: zhu m. Clin Infect Dis. 2021 Dec 6;73(11):e4278-e4287. doi: 10.1093/cid/ciaa1673. Clin Infect Dis. 2021. PMID: 33146720 Free PMC article. Clinical Trial.
Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant.
Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, Lalloo U, Masilela MSL, Moodley D, Hanley S, Fouche L, Louw C, Tameris M, Singh N, Goga A, Dheda K, Grobbelaar C, Kruger G, Carrim-Ganey N, Baillie V, de Oliveira T, Lombard Koen A, Lombaard JJ, Mngqibisa R, Bhorat AE, Benadé G, Lalloo N, Pitsi A, Vollgraaff PL, Luabeya A, Esmail A, Petrick FG, Oommen-Jose A, Foulkes S, Ahmed K, Thombrayil A, Fries L, Cloney-Clark S, Zhu M, Bennett C, Albert G, Faust E, Plested JS, Robertson A, Neal S, Cho I, Glenn GM, Dubovsky F, Madhi SA; 2019nCoV-501 Study Group. Shinde V, et al. Among authors: zhu m. N Engl J Med. 2021 May 20;384(20):1899-1909. doi: 10.1056/NEJMoa2103055. Epub 2021 May 5. N Engl J Med. 2021. PMID: 33951374 Free PMC article. Clinical Trial.
Comparison of the safety and immunogenicity of a novel Matrix-M-adjuvanted nanoparticle influenza vaccine with a quadrivalent seasonal influenza vaccine in older adults: a phase 3 randomised controlled trial.
Shinde V, Cho I, Plested JS, Agrawal S, Fiske J, Cai R, Zhou H, Pham X, Zhu M, Cloney-Clark S, Wang N, Zhou B, Lewis M, Price-Abbott P, Patel N, Massare MJ, Smith G, Keech C, Fries L, Glenn GM. Shinde V, et al. Among authors: zhu m. Lancet Infect Dis. 2022 Jan;22(1):73-84. doi: 10.1016/S1473-3099(21)00192-4. Epub 2021 Sep 23. Lancet Infect Dis. 2022. PMID: 34563277 Clinical Trial.
Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A/2B trial.
Madhi SA, Moodley D, Hanley S, Archary M, Hoosain Z, Lalloo U, Louw C, Fairlie L, Fouche LF, Masilela MSL, Singh N, Grobbelaar C, Ahmed K, Benadé G, Bhikha S, Bhorat AE, Bhorat Q, Joseph N, Dheda K, Esmail A, Foulkes S, Goga A, Oommen Jose A, Kruger G, Kalonji DJ, Lalloo N, Lombaard JJ, Lombard Koen A, Kany Luabeya A, Mngqibisa R, Petrick FG, Pitsi A, Tameris M, Thombrayil A, Vollgraaff PL, Cloney-Clark S, Zhu M, Bennett C, Albert G, Faust E, Plested JS, Fries L, Robertson A, Neal S, Cho I, Glenn GM, Shinde V; 2019nCoV-501 Study Group. Madhi SA, et al. Among authors: zhu m. Lancet HIV. 2022 May;9(5):e309-e322. doi: 10.1016/S2352-3018(22)00041-8. Lancet HIV. 2022. PMID: 35489376 Free PMC article. Clinical Trial.
Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a secondary analysis of a randomised, placebo-controlled, phase 2 trial.
Mallory RM, Formica N, Pfeiffer S, Wilkinson B, Marcheschi A, Albert G, McFall H, Robinson M, Plested JS, Zhu M, Cloney-Clark S, Zhou B, Chau G, Robertson A, Maciejewski S, Hammond HL, Baracco L, Logue J, Frieman MB, Smith G, Patel N, Glenn GM; Novavax 2019nCoV101 Study Group. Mallory RM, et al. Among authors: zhu m. Lancet Infect Dis. 2022 Nov;22(11):1565-1576. doi: 10.1016/S1473-3099(22)00420-0. Epub 2022 Aug 10. Lancet Infect Dis. 2022. PMID: 35963274 Free PMC article. Clinical Trial.
Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial.
Áñez G, Dunkle LM, Gay CL, Kotloff KL, Adelglass JM, Essink B, Campbell JD, Cloney-Clark S, Zhu M, Plested JS, Roychoudhury P, Greninger AL, Patel N, McGarry A, Woo W, Cho I, Glenn GM, Dubovsky F; 2019nCoV-301 – Pediatric Expansion Study Group. Áñez G, et al. Among authors: zhu m. medRxiv [Preprint]. 2022 Sep 21:2022.09.20.22279903. doi: 10.1101/2022.09.20.22279903. medRxiv. 2022. PMID: 36172135 Free PMC article. Preprint.
Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study.
Kulkarni PS, Kadam A, Godbole S, Bhatt V, Raut A, Kohli S, Tripathi S, Kulkarni P, Ludam R, Prabhu M, Bavdekar A, Gogtay NJ, Meshram S, Kadhiravan T, Kar S, Narayana DHA, Samuel C, Kulkarni G, Gaidhane A, Sathyapalan D, Raut S, Hadda V, Bhalla HL, Bhamare C, Dharmadhikari A, Plested JS, Cloney-Clarke S, Zhu M, Pryor M, Hamilton S, Thakar M, Shete A, Gautam M, Gupta N, Panda S, Shaligram U, Poonawalla CS, Bhargava B, Gunale B, Kapse D; COVOVAX Study Group. Kulkarni PS, et al. Among authors: zhu m. Lancet Reg Health Southeast Asia. 2023 Mar;10:100139. doi: 10.1016/j.lansea.2022.100139. Epub 2023 Jan 11. Lancet Reg Health Southeast Asia. 2023. PMID: 36647543 Free PMC article.
Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373.
Alves K, Plested JS, Galbiati S, Chau G, Cloney-Clark S, Zhu M, Kalkeri R, Patel N, Smith K, Marcheschi A, Pfeiffer S, McFall H, Smith G, Glenn GM, Dubovsky F, Mallory RM; Novavax 2019nCoV-101 Study Group. Alves K, et al. Among authors: zhu m. N Engl J Med. 2023 Mar 2;388(9):857-859. doi: 10.1056/NEJMc2215509. Epub 2023 Jan 25. N Engl J Med. 2023. PMID: 36734884 Free PMC article. No abstract available.
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