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Article ; Online: Prototype and BA.5 protein nanoparticle vaccines protect against Omicron BA.5 variant in Syrian hamsters.

Bricker, Traci L / Joshi, Astha / Soudani, Nadia / Scheaffer, Suzanne M / Patel, Nita / Guebre-Xabier, Mimi / Smith, Gale / Diamond, Michael S / Boon, Adrianus C M

Journal of virology

2024 Volume 98, Issue 3, Page(s) e0120623

Abstract: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants with greater transmissibility or immune evasion properties has jeopardized the existing vaccine and antibody-based countermeasures. Here, we evaluated the efficacy of ... ...

Abstract	The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants with greater transmissibility or immune evasion properties has jeopardized the existing vaccine and antibody-based countermeasures. Here, we evaluated the efficacy of boosting pre-immune hamsters with protein nanoparticle vaccines (Novavax, Inc.) containing recombinant Prototype (Wuhan-1) or BA.5 S proteins against a challenge with the Omicron BA.5 variant of SARS-CoV-2. Serum antibody binding and neutralization titers were quantified before challenge, and viral loads were measured 3 days after challenge. Boosting with Prototype or BA.5 vaccine induced similar antibody binding responses against ancestral Wuhan-1 or BA.5 S proteins, and neutralizing activity of Omicron BA.1 and BA.5 variants. One and three months after vaccine boosting, hamsters were challenged with the Omicron BA.5 variant. Prototype and BA.5 vaccine-boosted hamsters had reduced viral infection in the nasal washes, nasal turbinates, and lungs compared to unvaccinated animals. Although no significant differences in virus load were detected between the Prototype and BA.5 vaccine-boosted animals, fewer breakthrough infections were detected in the BA.5-vaccinated hamsters. Thus, immunity induced by Prototype or BA.5 S protein nanoparticle vaccine boosting can protect against the Omicron BA.5 variant in the Syrian hamster model. Importance: As SARS-CoV-2 continues to evolve, there may be a need to update the vaccines to match the newly emerging variants. Here, we compared the protective efficacy of the updated BA.5 and the original Wuhan-1 COVID-19 vaccine against a challenge with the BA.5 Omicron variant of SARS-CoV-2 in hamsters. Both vaccines induced similar levels of neutralizing antibodies against multiple variants of SARS-CoV-2. One and three months after the final immunization, hamsters were challenged with BA.5. No differences in protection against the BA.5 variant virus were observed between the two vaccines, although fewer breakthrough infections were detected in the BA.5-vaccinated hamsters. Together, our data show that both protein nanoparticle vaccines are effective against the BA.5 variant of SARS-CoV-2 but given the increased number of breakthrough infections and continued evolution, it is important to update the COVID-19 vaccine for long-term protection.
MeSH term(s)	Animals ; Cricetinae ; Antibodies, Neutralizing/immunology ; Antibodies, Viral/immunology ; Breakthrough Infections/immunology ; Breakthrough Infections/prevention & control ; Breakthrough Infections/virology ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19/virology ; COVID-19 Vaccines/immunology ; Mesocricetus/immunology ; Mesocricetus/virology ; Nanovaccines/immunology ; SARS-CoV-2/immunology ; Immunization, Secondary ; Viral Load
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines ; Nanovaccines
Language	English
Publishing date	2024-02-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	80174-4
ISSN	1098-5514 ; 0022-538X
ISSN (online)	1098-5514
ISSN	0022-538X
DOI	10.1128/jvi.01206-23
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Article: Immunogenicity and efficacy of XBB.1.5 rS vaccine against EG.5.1 variant of SARS-CoV-2 in Syrian hamsters.

Boon, Jacco / Soudani, Nadia / Bricker, Traci / Darling, Tamarand / Seehra, Kuljeet / Patel, Nita / Guebre-Xabier, Mimi / Smith, Gale / Suthar, Mehul / Ellebedy, Ali / Davis-Gardner, Meredith

Research square

2024

Abstract: The continued emergence of SARS-CoV-2 variants necessitates updating COVID-19 vaccines to match circulating strains. The immunogenicity and efficacy of these vaccines must be tested in pre-clinical animal models. In Syrian hamsters, we measured the ... ...

Abstract	The continued emergence of SARS-CoV-2 variants necessitates updating COVID-19 vaccines to match circulating strains. The immunogenicity and efficacy of these vaccines must be tested in pre-clinical animal models. In Syrian hamsters, we measured the humoral and cellular immune response after immunization with the nanoparticle recombinant Spike (S) protein-based COVID-19 vaccine (Novavax, Inc.). We also compared the efficacy of the updated monovalent XBB.1.5 variant vaccine to previous COVID-19 vaccines for the induction of XBB.1.5 and EG.5.1 neutralizing antibodies and protection against a challenge with the EG.5.1 variant of SARS-CoV-2. Immunization induced high levels of spike-specific serum IgG and IgA antibodies, S-specific IgG and IgA antibody secreting cells, and antigen specific CD4 + T-cells. The XBB.1.5 and XBB.1.16 vaccines, but not the Prototype vaccine, induced high levels of neutralizing antibodies against XBB.1.5 and EG.5.1 variants of SARS-CoV-2. Upon challenge with the Omicron EG.5.1 variant, the XBB.1.5 and XBB.1.16 vaccines reduced the virus load in the lungs, nasal turbinates, trachea and nasal washes. The bivalent vaccine continued to offer protection in the trachea and lungs, but protection was reduced in the upper airways. In contrast, the monovalent Prototype vaccine no longer offered good protection, and breakthrough infections were observed in all animals and tissues. Thus, the protein-based XBB.1.5 vaccine is immunogenic and can protect against the Omicron EG.5.1 variant in the Syrian hamster model.
Language	English
Publishing date	2024-02-09
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-3873514/v1
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Article ; Online: XBB.1.5 spike protein COVID-19 vaccine induces broadly neutralizing and cellular immune responses against EG.5.1 and emerging XBB variants.

Patel, Nita / Trost, Jessica F / Guebre-Xabier, Mimi / Zhou, Haixia / Norton, Jim / Jiang, Desheng / Cai, Zhaohui / Zhu, Mingzhu / Marchese, Anthony M / Greene, Ann M / Mallory, Raburn M / Kalkeri, Raj / Dubovsky, Filip / Smith, Gale

Scientific reports

2023 Volume 13, Issue 1, Page(s) 19176

Abstract: Monovalent SARS-CoV-2 Prototype (Wuhan-Hu-1) and bivalent (Prototype + BA.4/5) COVID-19 vaccines have demonstrated a waning of vaccine-mediated immunity highlighted by lower neutralizing antibody responses against SARS-CoV-2 Omicron XBB sub-variants. The ...

Abstract	Monovalent SARS-CoV-2 Prototype (Wuhan-Hu-1) and bivalent (Prototype + BA.4/5) COVID-19 vaccines have demonstrated a waning of vaccine-mediated immunity highlighted by lower neutralizing antibody responses against SARS-CoV-2 Omicron XBB sub-variants. The reduction of humoral immunity due to the rapid evolution of SARS-CoV-2 has signaled the need for an update to vaccine composition. A strain change for all authorized/approved vaccines to a monovalent composition with Omicron subvariant XBB.1.5 has been supported by the WHO, EMA, and FDA. Here, we demonstrate that immunization with a monovalent recombinant spike protein COVID-19 vaccine (Novavax, Inc.) based on the subvariant XBB.1.5 induces neutralizing antibodies against XBB.1.5, XBB.1.16, XBB.2.3, EG.5.1, and XBB.1.16.6 subvariants, promotes higher pseudovirus neutralizing antibody titers than bivalent (Prototype + XBB.1.5) vaccine, induces SARS-CoV-2 spike-specific Th1-biased CD4 + T-cell responses against XBB subvariants, and robustly boosts antibody responses in mice and nonhuman primates primed with a variety of monovalent and bivalent vaccines. Together, these data support updating the Novavax vaccine to a monovalent XBB.1.5 formulation for the 2023-2024 COVID-19 vaccination campaign.
MeSH term(s)	Animals ; Humans ; Mice ; COVID-19 Vaccines ; Spike Glycoprotein, Coronavirus ; COVID-19 ; SARS-CoV-2 ; Antibodies, Neutralizing ; Immunity, Cellular ; Antibodies, Viral
Chemical Substances	COVID-19 Vaccines ; spike protein, SARS-CoV-2 ; Spike Glycoprotein, Coronavirus ; Antibodies, Neutralizing ; Antibodies, Viral
Language	English
Publishing date	2023-11-06
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-46025-y
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Article: Diet Induced Obesity and Diabetes Enhance Mortality and Reduces Vaccine Efficacy for SARS-CoV-2.

Johnson, Robert / Ardunay, Jeremy / Hammond, Holly / Logue, James / Jackson, Lian / Baracco, Lauren / McGrath, Marisa / Dillen, Carly / Patel, Nita / Smith, Gale / Frieman, Matthew

bioRxiv : the preprint server for biology

2023

Abstract: Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), the causative agent of Coronavirus disease 2019 (COVID-19), emerged in Wuhan, China, in December 2019. As of October 2022, there have been over 625 million confirmed cases of COVID-19, ... ...

Abstract	Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), the causative agent of Coronavirus disease 2019 (COVID-19), emerged in Wuhan, China, in December 2019. As of October 2022, there have been over 625 million confirmed cases of COVID-19, including over 6.5 million deaths. Epidemiological studies have indicated that comorbidities of obesity and diabetes mellitus are associated with increased morbidity and mortality following SARS-CoV-2 infection. We determined how the comorbidities of obesity and diabetes affect morbidity and mortality following SARS-CoV-2 infection in unvaccinated and adjuvanted spike nanoparticle (NVX-CoV2373) vaccinated mice. We find that obese/diabetic mice infected with SARS-CoV-2 have increased morbidity and mortality compared to age matched normal mice. Mice fed a high-fat diet (HFD) then vaccinated with NVX-CoV2373 produce equivalent neutralizing antibody titers to those fed a normal diet (ND). However, the HFD mice have reduced viral clearance early in infection. Analysis of the inflammatory immune response in HFD mice demonstrates a recruitment of neutrophils that was correlated with increased mortality and reduced clearance of the virus. Depletion of neutrophils in diabetic/obese vaccinated mice reduced disease severity and protected mice from lethality. This model recapitulates the increased disease severity associated with obesity and diabetes in humans with COVID-19 and is an important comorbidity to study with increasing obesity and diabetes across the world.
Language	English
Publishing date	2023-05-05
Publishing country	United States
Document type	Preprint
DOI	10.1101/2022.10.15.512291
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Article ; Online: A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Novavax COVID-19 Vaccine (NVX-CoV2373), a recombinant spike protein vaccine with Matrix-M adjuvant to prevent disease caused by SARS-CoV-2 viruses.

Wilkinson, Bethanie / Patel, Kinjal S / Smith, Katherine / Walker, Robert / Wang, Chengbin / Greene, Ann M / Smith, Gale / Smith, Emily R / Gurwith, Marc / Chen, Robert T

Vaccine

2023 Volume 41, Issue 45, Page(s) 6762–6773

Abstract: Novavax, a global vaccine company, began evaluating NVX-CoV2373 in human studies in May 2020 and the pivotal placebo-controlled phase 3 studies started in November 2020; five clinical studies provided adult and adolescent clinical data for over 31,000 ... ...

Abstract	Novavax, a global vaccine company, began evaluating NVX-CoV2373 in human studies in May 2020 and the pivotal placebo-controlled phase 3 studies started in November 2020; five clinical studies provided adult and adolescent clinical data for over 31,000 participants who were administered NVX-CoV2373. This extensive data has demonstrated a well-tolerated response to NVX-CoV2373 and high vaccine efficacy against mild, moderate, or severe COVID-19 using a two-dose series (Dunkle et al., 2022) [1], (Heath et al., 2021) [2], (Keech et al., 2020) [3], (Mallory et al., 2022) [4]. The most common adverse events seen after administration with NVX-CoV2373 were injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, nausea, or vomiting. In addition, immunogenicity against variants of interest (VOI) and variants of concern (VOC) was established with high titers of ACE2 receptor-inhibiting and neutralizing antibodies in these studies (EMA, 2022) [5], (FDA, 2023) [6]. Further studies on correlates of protection determined that titers of anti-Spike IgG and neutralizing antibodies correlated with efficacy against symptomatic COVID-19 established in clinical trials (p < 0.001 for recombinant protein vaccine and p = 0.005 for mRNA vaccines for IgG levels) (Fong et al., 2022) [7]. Administration of a booster dose of the recombinant protein vaccine approximately 6 months following the primary two-dose series resulted in substantial increases in humoral antibodies against both the prototype strain and all evaluated variants, similar to or higher than the antibody levels observed in phase 3 studies that were associated with high vaccine efficacy (Dunkle et al., 2022) [1], (Mallory et al., 2022) [4]. These findings, together with the well tolerated safety profile, support use of the recombinant protein vaccine as primary series and booster regimens.
MeSH term(s)	Adolescent ; Adult ; Humans ; COVID-19 Vaccines/adverse effects ; SARS-CoV-2 ; Spike Glycoprotein, Coronavirus/genetics ; COVID-19/prevention & control ; Adjuvants, Immunologic ; Vaccines, Synthetic/adverse effects ; Vaccines, Synthetic/genetics ; Antibodies, Neutralizing ; Risk Assessment ; Immunoglobulin G ; Antibodies, Viral ; Immunogenicity, Vaccine
Chemical Substances	NVX-CoV2373 adjuvated lipid nanoparticle (2SCD8Q63PF) ; COVID-19 Vaccines ; Matrix-M ; spike protein, SARS-CoV-2 ; Spike Glycoprotein, Coronavirus ; Adjuvants, Immunologic ; Vaccines, Synthetic ; Antibodies, Neutralizing ; Immunoglobulin G ; Antibodies, Viral
Language	English
Publishing date	2023-09-20
Publishing country	Netherlands
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, U.S. Gov't, P.H.S. ; Research Support, N.I.H., Extramural
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.07.040
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Zs.A 1930: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 458: Show issues

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Article ; Online: Diet-induced obesity and diabetes enhance mortality and reduce vaccine efficacy for SARS-CoV-2.

Johnson, Robert M / Ardanuy, Jeremy / Hammond, Holly / Logue, James / Jackson, Lian / Baracco, Lauren / McGrath, Marisa / Dillen, Carly / Patel, Nita / Smith, Gale / Frieman, Matthew

Journal of virology

2023 Volume 97, Issue 11, Page(s) e0133623

Abstract: Importance: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a wide spectrum of diseases in the human population, from asymptomatic infections to death. It is important to study the host differences that may alter the pathogenesis ...

Abstract	Importance: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a wide spectrum of diseases in the human population, from asymptomatic infections to death. It is important to study the host differences that may alter the pathogenesis of this virus. One clinical finding in coronavirus disease 2019 (COVID-19) patients is that people with obesity or diabetes are at increased risk of severe illness from SARS-CoV-2 infection. We used a high-fat diet model in mice to study the effects of obesity and type 2 diabetes on SARS-CoV-2 infection as well as how these comorbidities alter the response to vaccination. We find that diabetic/obese mice have increased disease after SARS-CoV-2 infection and they have slower clearance of the virus. We find that the lungs of these mice have increased neutrophils and that removing these neutrophils protects diabetic/obese mice from disease. This demonstrates why these diseases have increased risk of severe disease and suggests specific interventions upon infection.
MeSH term(s)	Animals ; Humans ; Mice ; COVID-19/prevention & control ; Diabetes Mellitus, Type 2/complications ; Diet ; Mice, Obese ; Obesity/complications ; SARS-CoV-2 ; Vaccine Efficacy ; COVID-19 Vaccines/administration & dosage
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2023-10-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	80174-4
ISSN	1098-5514 ; 0022-538X
ISSN (online)	1098-5514
ISSN	0022-538X
DOI	10.1128/jvi.01336-23
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Article ; Online: Author Correction: Intradermal immunization by Ebola virus GP subunit vaccines using microneedle patches protects mice against lethal EBOV challenge.

Liu, Ying / Ye, Ling / Lin, Fang / Gomaa, Yasmine / Flyer, David / Carrion, Ricardo / Patterson, Jean L / Prausnitz, Mark R / Smith, Gale / Glenn, Gregory / Wu, Hua / Compans, Richard W / Yang, Chinglai

Scientific reports

2023 Volume 13, Issue 1, Page(s) 13705

Language	English
Publishing date	2023-08-22
Publishing country	England
Document type	Published Erratum
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-40413-0
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Article ; Online: The Matrix-M™ adjuvant: A critical component of vaccines for the 21

Stertman, Linda / Palm, Anna-Karin E / Zarnegar, Behdad / Carow, Berit / Lunderius Andersson, Carolina / Magnusson, Sofia E / Carnrot, Cecilia / Shinde, Vivek / Smith, Gale / Glenn, Gregory / Fries, Louis / Lövgren Bengtsson, Karin

Human vaccines & immunotherapeutics

2023 Volume 19, Issue 1, Page(s) 2189885

Abstract: Matrix-M™ adjuvant is a key component of several novel vaccine candidates. The Matrix-M adjuvant consists of two distinct fractions of saponins purified from ... ...

Abstract	Matrix-M™ adjuvant is a key component of several novel vaccine candidates. The Matrix-M adjuvant consists of two distinct fractions of saponins purified from the
MeSH term(s)	Humans ; COVID-19/prevention & control ; SARS-CoV-2 ; Vaccines ; Adjuvants, Immunologic ; Saponins
Chemical Substances	Vaccines ; Adjuvants, Immunologic ; Saponins
Language	English
Publishing date	2023-04-27
Publishing country	United States
Document type	Review ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2664176-8
ISSN	2164-554X ; 2164-5515
ISSN (online)	2164-554X
ISSN	2164-5515
DOI	10.1080/21645515.2023.2189885
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Article ; Online: NVX-CoV2373 ancestral and NVX-CoV2540 BA.5 protein nanoparticle vaccines protect against Omicron BA.5 variant in Syrian hamsters

Bricker, Traci L / Joshi, Astha / Soudani, Nadia / Scheaffer, Suzanne / Patel, Nita / Xabier, Mimi Guebre / Smith, Gale / Diamond, Michael / Boon, Adrianus C

bioRxiv

Abstract: The emergence of SARS-CoV-2 variants with greater transmissibility or immune evasion properties has jeopardized the existing vaccine and antibody-based countermeasures. Here, we evaluated the efficacy of boosting with the protein nanoparticle NVX-CoV2373 ...

Abstract	The emergence of SARS-CoV-2 variants with greater transmissibility or immune evasion properties has jeopardized the existing vaccine and antibody-based countermeasures. Here, we evaluated the efficacy of boosting with the protein nanoparticle NVX-CoV2373 or NVX-CoV2540 vaccines containing ancestral or BA.5 S proteins, respectively, in mRNA-immunized pre-immune hamsters, against challenge with the Omicron BA.5 variant of SARS-CoV-2. Serum antibody binding and neutralization titers were quantified before challenge, and viral loads were measured 3 days after challenge. Compared to an mRNA vaccine boost, NVX-CoV2373 or NVX-CoV2540 induced higher serum antibody binding responses against ancestral Wuhan-1 or BA.5 spike proteins, and greater neutralization of Omicron BA.1 and BA.5 variants. One and three months after vaccine boosting, hamsters were challenged with the Omicron BA.5 variant. NVX-CoV2373 and NVX-CoV2540 boosted hamsters showed reduced viral infection in the nasal washes, nasal turbinates, and lungs compared to unvaccinated animals. Also, NVX-CoV2540 BA.5 boosted animals had fewer breakthrough infections than NVX-CoV2373 or mRNA-vaccinated hamsters. Thus, immunity induced by NVX-CoV2373 or NVX-CoV2540 boosting can protect against the Omicron BA.5 variant in the Syrian hamster model.
Keywords	covid19
Language	English
Publishing date	2023-08-08
Publisher	Cold Spring Harbor Laboratory
Document type	Article ; Online
DOI	10.1101/2023.08.07.552330
Database	COVID19

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Article ; Online: Neutralization of SARS-CoV-2 Variants B.1.429 and B.1.351.

Shen, Xiaoying / Tang, Haili / Pajon, Rolando / Smith, Gale / Glenn, Gregory M / Shi, Wei / Korber, Bette / Montefiori, David C

The New England journal of medicine

2021 Volume 384, Issue 24, Page(s) 2352–2354

MeSH term(s)	2019-nCoV Vaccine mRNA-1273 ; Antibodies, Neutralizing/blood ; Antibodies, Neutralizing/immunology ; Antibodies, Viral/blood ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19 Vaccines/immunology ; Cross Reactions/immunology ; Humans ; Microbiological Techniques ; Mutation ; Neutralization Tests ; SARS-CoV-2/genetics ; SARS-CoV-2/immunology ; Spike Glycoprotein, Coronavirus/genetics
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2 ; NVX-CoV2373 adjuvated lipid nanoparticle (2SCD8Q63PF) ; 2019-nCoV Vaccine mRNA-1273 (EPK39PL4R4)
Language	English
Publishing date	2021-04-07
Publishing country	United States
Document type	Letter
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2103740
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