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Article ; Online: The quest for a cytomegalovirus vaccine continues.

Chiuppesi, Flavia / Wussow, Felix

2023 Volume 23, Issue 12, Page(s) 1330–1332

MeSH term(s)	Humans ; Cytomegalovirus Vaccines ; Cytomegalovirus Infections/prevention & control ; Cytomegalovirus ; Immunization ; Antibodies, Viral
Chemical Substances	Cytomegalovirus Vaccines ; Antibodies, Viral
Language	English
Publishing date	2023-08-31
Publishing country	United States
Document type	Journal Article
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(23)00361-4
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Synthetic multiantigen MVA vaccine COH04S1 and variant-specific derivatives protect Syrian hamsters from SARS-CoV-2 Omicron subvariants.

Wussow, Felix / Kha, Mindy / Kim, Taehyun / Ly, Minh / Yll-Pico, Marcal / Kar, Swagata / Lewis, Mark G / Chiuppesi, Flavia / Diamond, Don J

NPJ vaccines

2023 Volume 8, Issue 1, Page(s) 41

Abstract: Emerging SARS-CoV-2 Omicron subvariants continue to disrupt COVID-19 vaccine efficacy through multiple immune mechanisms including neutralizing antibody evasion. We developed COH04S1, a synthetic modified vaccinia Ankara vector that co-expresses Wuhan-Hu- ...

Abstract	Emerging SARS-CoV-2 Omicron subvariants continue to disrupt COVID-19 vaccine efficacy through multiple immune mechanisms including neutralizing antibody evasion. We developed COH04S1, a synthetic modified vaccinia Ankara vector that co-expresses Wuhan-Hu-1-based spike and nucleocapsid antigens. COH04S1 demonstrated efficacy against ancestral virus and Beta and Delta variants in animal models and was safe and immunogenic in a Phase 1 clinical trial. Here, we report efficacy of COH04S1 and analogous Omicron BA.1- and Beta-specific vaccines to protect Syrian hamsters from Omicron subvariants. Despite eliciting strain-specific antibody responses, all three vaccines protect hamsters from weight loss, lower respiratory tract infection, and lung pathology following challenge with Omicron BA.1 or BA.2.12.1. While the BA.1-specifc vaccine affords consistently improved efficacy compared to COH04S1 to protect against homologous challenge with BA.1, all three vaccines confer similar protection against heterologous challenge with BA.2.12.1. These results demonstrate efficacy of COH04S1 and variant-specific derivatives to confer cross-protective immunity against SARS-CoV-2 Omicron subvariants.
Language	English
Publishing date	2023-03-16
Publishing country	England
Document type	Journal Article
ISSN	2059-0105
ISSN (online)	2059-0105
DOI	10.1038/s41541-023-00640-y
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Highly stable and immunogenic CMV T cell vaccine candidate developed using a synthetic MVA platform.

Yll-Pico, Marcal / Park, Yoonsuh / Martinez, Joy / Iniguez, Angelina / Kha, Mindy / Kim, Taehyun / Medrano, Leonard / Nguyen, Vu H / Kaltcheva, Teodora / Dempsey, Shannon / Chiuppesi, Flavia / Wussow, Felix / Diamond, Don J

NPJ vaccines

2024 Volume 9, Issue 1, Page(s) 68

Abstract: Human cytomegalovirus (CMV) is the most common infectious cause of complications post-transplantation, while a CMV vaccine for transplant recipients has yet to be licensed. Triplex, a multiantigen Modified Vaccinia Ankara (MVA)-vectored CMV vaccine ... ...

Abstract	Human cytomegalovirus (CMV) is the most common infectious cause of complications post-transplantation, while a CMV vaccine for transplant recipients has yet to be licensed. Triplex, a multiantigen Modified Vaccinia Ankara (MVA)-vectored CMV vaccine candidate based on the immunodominant antigens phosphoprotein 65 (pp65) and immediate-early 1 and 2 (IE1/2), is in an advanced stage of clinical development. However, its limited genetic and expression stability restricts its potential for large-scale production. Using a recently developed fully synthetic MVA (sMVA) platform, we developed a new generation Triplex vaccine candidate, T10-F10, with different sequence modifications for enhanced vaccine stability. T10-F10 demonstrated genetic and expression stability during extensive virus passaging. In addition, we show that T10-F10 confers comparable immunogenicity to the original Triplex vaccine to elicit antigen-specific T cell responses in HLA-transgenic mice. These results demonstrate improvements in translational vaccine properties of an sMVA-based CMV vaccine candidate designed as a therapeutic treatment for transplant recipients.
Language	English
Publishing date	2024-03-30
Publishing country	England
Document type	Journal Article
ISSN	2059-0105
ISSN (online)	2059-0105
DOI	10.1038/s41541-024-00859-3
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Synthetic modified vaccinia Ankara vaccines confer cross-reactive and protective immunity against mpox virus.

Chiuppesi, Flavia / Zaia, John A / Gutierrez-Franco, Miguel-Angel / Ortega-Francisco, Sandra / Ly, Minh / Kha, Mindy / Kim, Taehyun / Dempsey, Shannon / Kar, Swagata / Grifoni, Alba / Sette, Alessandro / Wussow, Felix / Diamond, Don J

Communications medicine

2024 Volume 4, Issue 1, Page(s) 19

Abstract: Background: Although the mpox global health emergency caused by mpox virus (MPXV) clade IIb.1 has ended, mpox cases are still reported due to low vaccination coverage and waning immunity. COH04S1 is a clinically evaluated, multiantigen COVID-19 vaccine ... ...

Abstract	Background: Although the mpox global health emergency caused by mpox virus (MPXV) clade IIb.1 has ended, mpox cases are still reported due to low vaccination coverage and waning immunity. COH04S1 is a clinically evaluated, multiantigen COVID-19 vaccine candidate built on a fully synthetic platform of the highly attenuated modified vaccinia Ankara (MVA) vector, representing the only FDA-approved smallpox/mpox vaccine JYNNEOS. Given the potential threat of MPXV resurgence and need for vaccine alternatives, we aimed to assess the capacity COH04S1 and its synthetic MVA (sMVA) backbone to confer MPXV-specific immunity. Methods: We evaluated orthopoxvirus-specific and MPXV cross-reactive immune responses in samples collected during a Phase 1 clinical trial of COH04S1 and in non-human primates (NHP) vaccinated with COH04S1 or its sMVA backbone. MPXV cross-reactive immune responses in COH04S1-vaccinated healthy adults were compared to responses measured in healthy subjects vaccinated with JYNNEOS. Additionally, we evaluated the protective efficacy of COH04S1 and sMVA against mpox in mpox-susceptible CAST/EiJ mice. Results: COH04S1-vaccinated individuals develop robust orthopoxvirus-specific humoral and cellular responses, including cross-reactive antibodies to MPXV-specific virion proteins as well as MPXV cross-neutralizing antibodies in 45% of the subjects. In addition, NHP vaccinated with COH04S1 or sMVA show similar MPXV cross-reactive antibody responses. Moreover, MPXV cross-reactive humoral responses elicited by COH04S1 are comparable to those measured in JYNNEOS-vaccinated subjects. Finally, we show that mice vaccinated with COH04S1 or sMVA are protected from lung infection following challenge with MPXV clade IIb.1. Conclusions: These results demonstrate the capacity of sMVA vaccines to elicit cross-reactive and protective orthopox-specific immunity against MPXV, suggesting that COH04S1 and sMVA could be developed as bivalent or monovalent mpox vaccine alternatives against MPXV.
Language	English
Publishing date	2024-02-16
Publishing country	England
Document type	Journal Article
ISSN	2730-664X
ISSN (online)	2730-664X
DOI	10.1038/s43856-024-00443-9
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Leflunomide Confers Rapid Recovery from COVID-19 and is Coupled with Temporal Immunologic Changes.

Dona, Ada Alice / Sanchez, James F / Palmer, Joycelynne M / Synold, Timothy W / Chiuppesi, Flavia / Thomas, Sandra / Caserta, Enrico / Singer, Mahmoud / Tandoh, Theophilus / Chowdhury, Arnab / Krishnan, Amrita / Rosenzweig, Michael / Diamond, Don J / Rosen, Steven / Pichiorri, Flavia / Dadwal, Sanjeet

Journal of immunological sciences

2023 Volume 7, Issue 1, Page(s) 9–27

Abstract: Background: Vaccines for SARS-CoV-2 have been considerably effective in reducing rates of infection and severe COVID-19. However, many patients, especially those who are immunocompromised due to cancer or other factors, as well as individuals who are ... ...

Abstract	Background: Vaccines for SARS-CoV-2 have been considerably effective in reducing rates of infection and severe COVID-19. However, many patients, especially those who are immunocompromised due to cancer or other factors, as well as individuals who are unable to receive vaccines or are in resource-poor countries, will continue to be at risk for COVID-19. We describe clinical, therapeutic, and immunologic correlatives in two patients with cancer and severe COVID-19 who were treated with leflunomide after failing to respond to standard-of-care comprising remdesivir and dexamethasone. Both patients had breast cancer and were on therapy for the malignancy. Methods: The protocol is designed with the primary objective to assess the safety and tolerability of leflunomide in treating severe COVID-19 in patients with cancer. Leflunomide dosing consisted of a loading dose of 100 mg daily for the first three days, followed by daily dosing, at the assigned dose level (Dose Level 1: 40 mg, Dose Level -1, 20 mg; Dose Level 2, 60 mg), for an additional 11 days. At defined intervals, serial monitoring of blood samples for toxicity, pharmacokinetics, and immunologic correlative studies were performed, as well as nasopharyngeal swabs for PCR analysis of SARS-CoV-2. Results: Preclinically, leflunomide impaired viral RNA replication, and clinically, it led to a rapid improvement in the two patients discussed herein. Both patients completely recovered, with minimal toxicities; all adverse events experienced were considered unrelated to leflunomide. Single-cell mass-cytometry analysis showed that leflunomide increased levels of CD8+ cytotoxic and terminal effector T cells and decreased naïve and memory B cells. Conclusions: With ongoing COVID-19 transmission and occurrence of breakthrough infections in vaccinated individuals, including patients with cancer, therapeutic agents that target both the virus and host inflammatory response would be helpful despite the availability of currently approved anti-viral agents. Furthermore, from an access to care perspective, especially in resource-limited areas, an inexpensive, readily available, effective drug with existing safety data in humans is relevant in the real-world setting.
Language	English
Publishing date	2023-01-20
Publishing country	United States
Document type	Journal Article
DOI	10.29245/2578-3009/2023/1.1241
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Induction of poxviral immunity by synthetic MVA-based dual-antigen COVID-19 vaccine COH04S1

Chiuppesi, Flavia / Zaia, John A / Francisco, Sandra Ortega / Ly, Michael / Wussow, Felix / Diamond, Don J

medRxiv

Abstract: The recent outbreak of monkeypox outside its endemic boundaries has attracted global attention and prompted world leaders to reserve thousands of doses of the only approved third-generation smallpox/monkeypox vaccine Jynneos, which is based on the highly ...

Abstract	The recent outbreak of monkeypox outside its endemic boundaries has attracted global attention and prompted world leaders to reserve thousands of doses of the only approved third-generation smallpox/monkeypox vaccine Jynneos, which is based on the highly attenuated modified vaccinia Ankara (MVA) vector. Given the potential urgency to vaccinate individuals at risk in both endemic and non-endemic countries to curtail further spread of the outbreak, there is a legitimate need for substantial doses of smallpox/monkeypox vaccines. We previously developed COH04S1, a multiantigen SARS-CoV-2 vaccine candidate built on a synthetic MVA platform. COH04S1 was found to be safe and to induce SARS-CoV-2-specific immune responses in healthy adults participating in a phase 1, blinded, randomized, placebo-controlled clinical trial. Here we perform a retrospective analysis of vaccine-induced orthopoxvirus immunity in a subgroup of volunteers enrolled in the phase 1 clinical trial that were vaccinated with COH04S1 at different doses. At all dose levels, vaccination with COH04S1 resulted in robust MVA-specific binding and neutralizing antibody responses, which were sustained over six months post-vaccination. Similarly, both CD8+ and CD4+ T cells specific for MVA were induced by COH04S1 vaccination and remained durable for at least six months. Given that both arms of the immune response are thought to be involved in protection against orthopoxvirus infections, our results indicate that COH04S1 or other sMVA-based vaccines may represent valuable candidates for smallpox/monkeypox vaccination.
Keywords	covid19
Language	English
Publishing date	2022-07-29
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2022.07.26.22277958
Database	COVID19

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Article ; Online: COH04S1 and beta sequence-modified vaccine protect hamsters from SARS-CoV-2 variants.

Wussow, Felix / Kha, Mindy / Faircloth, Katelyn / Nguyen, Vu H / Iniguez, Angelina / Martinez, Joy / Park, Yoonsuh / Nguyen, Jenny / Kar, Swagata / Andersen, Hanne / Lewis, Mark G / Chiuppesi, Flavia / Diamond, Don J

iScience

2022 Volume 25, Issue 6, Page(s) 104457

Abstract: COVID-19 vaccine efficacy is threatened by emerging SARS-CoV-2 variants of concern (VOC) with the capacity to evade protective neutralizing antibody responses. We recently developed clinical vaccine candidate COH04S1, a synthetic modified vaccinia Ankara ...

Abstract	COVID-19 vaccine efficacy is threatened by emerging SARS-CoV-2 variants of concern (VOC) with the capacity to evade protective neutralizing antibody responses. We recently developed clinical vaccine candidate COH04S1, a synthetic modified vaccinia Ankara vector (sMVA) co-expressing spike and nucleocapsid antigens based on the Wuhan-Hu-1 reference strain that showed potent efficacy to protect against ancestral SARS-CoV-2 in Syrian hamsters and non-human primates and was safe and immunogenic in healthy volunteers. Here, we demonstrate that intramuscular immunization of Syrian hamsters with COH04S1 and an analogous Beta variant-adapted vaccine candidate (COH04S351) elicits potent cross-reactive antibody responses and protects against weight loss, lower respiratory tract infection, and lung pathology following challenge with major SARS-CoV-2 VOC, including Beta and the highly contagious Delta variant. These results demonstrate efficacy of COH04S1 and a variant-adapted vaccine analog to confer cross-protective immunity against SARS-CoV-2 and its emerging VOC, supporting clinical investigation of these sMVA-based COVID-19 vaccine candidates.
Language	English
Publishing date	2022-05-23
Publishing country	United States
Document type	Journal Article
ISSN	2589-0042
ISSN (online)	2589-0042
DOI	10.1016/j.isci.2022.104457
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Adoptive transfer of functional SARS-COV-2-specific immunity from donor graft to hematopoietic stem cell transplant recipients.

La Rosa, Corinna / Chiuppesi, Flavia / Park, Yoonsuh / Gendzekhadze, Ketevan / Zhou, Qiao / Faircloth, Katelyn / Kaltcheva, Teodora / Johnson, Daisy / Ortega Francisco, Sandra / Amanam, Idoroenyi / Otoukesh, Salman / Pullarkat, Vinod A / Nakamura, Ryotaro / Diamond, Don J / Forman, Stephen J / Al Malki, Monzr M

American journal of hematology

2022 Volume 97, Issue 11, Page(s) E404–E407

MeSH term(s)	Adoptive Transfer ; COVID-19 ; Graft vs Host Disease/etiology ; Hematopoietic Stem Cell Transplantation ; Humans ; SARS-CoV-2
Language	English
Publishing date	2022-09-02
Publishing country	United States
Document type	Letter ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	196767-8
ISSN	1096-8652 ; 0361-8609
ISSN (online)	1096-8652
ISSN	0361-8609
DOI	10.1002/ajh.26691
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Article: Neutralization of Human Cytomegalovirus Entry into Fibroblasts and Epithelial Cells.

Wussow, Felix / Chiuppesi, Flavia / Contreras, Heidi / Diamond, Don J

Vaccines

2017 Volume 5, Issue 4

Abstract: Human cytomegalovirus (HCMV) is a leading cause of permanent birth defects, highlighting the need to develop an HCMV vaccine candidate. However, HCMV vaccine development is complicated by the varying capacity of neutralizing antibodies (NAb) to interfere ...

Abstract	Human cytomegalovirus (HCMV) is a leading cause of permanent birth defects, highlighting the need to develop an HCMV vaccine candidate. However, HCMV vaccine development is complicated by the varying capacity of neutralizing antibodies (NAb) to interfere in vitro with the HCMV entry routes mediating infection of fibroblast (FB) and epithelial cells (EC). While HCMV infection of FB and EC requires glycoprotein complexes composed of gB and gH/gL/gO, EC infection depends additionally on the envelope pentamer complex (PC) composed of gH, gL, UL128, UL130 and UL131A. Unlike NAb to gB or gH epitopes that can interfere with both FB and EC infection, NAb targeting predominantly conformational epitopes of the UL128/130/131A subunits are unable to prevent FB entry, though they are highly potent in blocking EC infection. Despite the selective requirement of the PC for EC entry, the PC is exceptionally immunogenic as vaccine antigen to stimulate both EC- and FB-specific NAb responses due to its capacity to elicit NAb that target epitopes of the UL128/130/131A subunits and gH. These findings suggest that the PC could be sufficient in a subunit vaccine formulation to induce robust FB- and EC-specific NAb responses. In this short review, we discuss NAb responses induced through natural infection and vaccination that interfere in vitro with HCMV infection of FB and EC.
Language	English
Publishing date	2017-10-31
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines5040039
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Article ; Online: COH04S1 and beta sequence-modified vaccine protect hamsters from SARS-CoV-2 variants

Felix Wussow / Mindy Kha / Katelyn Faircloth / Vu H. Nguyen / Angelina Iniguez / Joy Martinez / Yoonsuh Park / Jenny Nguyen / Swagata Kar / Hanne Andersen / Mark G. Lewis / Flavia Chiuppesi / Don J. Diamond

iScience, Vol 25, Iss 6, Pp 104457- (2022)

2022

Abstract: Summary: COVID-19 vaccine efficacy is threatened by emerging SARS-CoV-2 variants of concern (VOC) with the capacity to evade protective neutralizing antibody responses. We recently developed clinical vaccine candidate COH04S1, a synthetic modified ... ...

Abstract	Summary: COVID-19 vaccine efficacy is threatened by emerging SARS-CoV-2 variants of concern (VOC) with the capacity to evade protective neutralizing antibody responses. We recently developed clinical vaccine candidate COH04S1, a synthetic modified vaccinia Ankara vector (sMVA) co-expressing spike and nucleocapsid antigens based on the Wuhan-Hu-1 reference strain that showed potent efficacy to protect against ancestral SARS-CoV-2 in Syrian hamsters and non-human primates and was safe and immunogenic in healthy volunteers. Here, we demonstrate that intramuscular immunization of Syrian hamsters with COH04S1 and an analogous Beta variant-adapted vaccine candidate (COH04S351) elicits potent cross-reactive antibody responses and protects against weight loss, lower respiratory tract infection, and lung pathology following challenge with major SARS-CoV-2 VOC, including Beta and the highly contagious Delta variant. These results demonstrate efficacy of COH04S1 and a variant-adapted vaccine analog to confer cross-protective immunity against SARS-CoV-2 and its emerging VOC, supporting clinical investigation of these sMVA-based COVID-19 vaccine candidates.
Keywords	Biological sciences ; Immunology ; Virology ; Science ; Q
Language	English
Publishing date	2022-06-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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