Neil T. Formica

Strong CD4+ T-Cell Responses to Ancestral and Variant Spike Proteins Are Established by NVX-CoV2373 Severe Acute Respiratory Syndrome Coronavirus 2 Primary Vaccination

Louis F Fries, Neil T. Formica, Raburn M. Mallory, Haixia Zhou et autres

BACKGROUND: NVX-CoV2373 is an efficacious coronavirus disease 2019 (COVID-19) vaccine comprising full-length recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (rS) glycoprotein and Matrix-M adjuvant. Phase 2 of a randomized, placebo-controlled, phase 1/2 trial in healthy adults (18-84 years of age) …

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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

Raburn M. Mallory, Neil T. Formica, Susan Pfeiffer, Bethanie E. Wilkinson et autres

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Immunogenicity and Safety Following a Homologous Booster Dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): A Phase 2 Randomized Placebo-Controlled Trial

Raburn M. Mallory, Neil T. Formica, Susan Pfeiffer, Bethanie E. Wilkinson et autres

SUMMARY Background Emerging SARS-CoV-2 variants and evidence of waning vaccine efficacy present significant obstacles toward controlling the COVID-19 pandemic. Booster doses of SARS-CoV-2 vaccines may address these concerns by both amplifying and broadening the immune responses seen with initial vaccination regimens. Methods …

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Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: A phase 2 randomized placebo-controlled trial

Neil T. Formica, Raburn M. Mallory, Gary R. Albert, Michelle Robinson et autres

BACKGROUND: NVX-CoV2373 is a recombinant severe acute respiratory coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins and Matrix-M1 adjuvant. METHODS AND FINDINGS: The phase 2 component of our randomized, placebo-controlled, phase 1 to 2 trial was designed to …

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Evaluation of a SARS-CoV-2 Vaccine NVX-CoV2373 in Younger and Older Adults

Neil T. Formica, Raburn M. Mallory, Gary R. Albert, Michelle Robinson et autres

ABSTRACT Background NVX-CoV2373 is a recombinant severe acute respiratory coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins and Matrix-M1 adjuvant. Methods The phase 2 component of our randomized, placebo-controlled, phase 1-2 trial was designed to identify which dosing …

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Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine

Cheryl A. Keech, Gary R. Albert, Iksung Cho, Andreana Robertson et autres

BACKGROUND: NVX-CoV2373 is a recombinant severe acute respiratory syndrome coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins and Matrix-M1 adjuvant. METHODS: We initiated a randomized, placebo-controlled, phase 1-2 trial to evaluate the safety and immunogenicity of the rSARS-CoV-2 …

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First-in-Human Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine

Cheryl A. Keech, Gregory M. Glenn, Gary R. Albert, Iksung Cho et autres

Abstract Background NVX-CoV2373 is a recombinant nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins. We present the Day 35 primary analysis of our trial of NVX-CoV2373 with or without the saponin-based Matrix-M1 adjuvant in healthy adults. Methods This is a randomized, …

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Immunogenicity and safety of a quadrivalent inactivated influenza virus vaccine compared with a comparator quadrivalent inactivated influenza vaccine in a pediatric population: A phase 3, randomized noninferiority study

Jolanta Airey, Frank R. Albano, Daphne C. Sawlwin, Alison Graves Jones et autres

BACKGROUND: Seqirus 2010 Southern Hemisphere split-virion trivalent inactivated influenza vaccine (IIV3) was associated with increased febrile reactions in children. Studies in vitro concluded that increasing concentrations of splitting agent decreased residual lipids and attenuated proinflammatory cytokine signals associated with fever. We assessed …

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Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority study

John Treanor, Frank R. Albano, Daphne C. Sawlwin, Alison Graves Jones et autres

BACKGROUND: Vaccination is the most effective means of influenza prevention. Efficacy of trivalent vaccines may be enhanced by including both B strain lineages. This phase 3, double-blind study assessed the immunogenicity and safety/tolerability of a quadrivalent inactivated influenza vaccine (IIV4) versus the …

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Randomized Study to Compare Immunogenicity and Safety of Seqirus* Quadrivalent Inactivated Influenza Vaccine With a US-Registered Influenza Vaccine in Pediatric Subjects Aged 5 to 17 Years

Jane Leong, Daphne C. Sawlwin, Alison Graves-Jones, Neil T. Formica et autres

Background. Seqirus has commenced a staged clinical program for a quadrivalent inactivated influenza vaccine. Pediatric clinical studies have been initiated following completion of the adult study. Methods. Children aged 5 through 17 years were randomized 3:1 to receive Seqirus QIV (n = …

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Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children

Terry M. Nolan, Peter Richmond, Neil T. Formica, Katja Höschler et autres

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Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults

Terry M. Nolan, Peter Richmond, MARYANNE V. SKELJO, Georgina Pearce et autres

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