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Article ; Online: Novel approaches for vaccine development.

Gebre, Makda S / Brito, Luis A / Tostanoski, Lisa H / Edwards, Darin K / Carfi, Andrea / Barouch, Dan H

2021 Volume 184, Issue 6, Page(s) 1589–1603

Abstract: Vaccines are critical tools for maintaining global health. Traditional vaccine technologies have been used across a wide range of bacterial and viral pathogens, yet there are a number of examples where they have not been successful, such as for ... ...

Abstract	Vaccines are critical tools for maintaining global health. Traditional vaccine technologies have been used across a wide range of bacterial and viral pathogens, yet there are a number of examples where they have not been successful, such as for persistent infections, rapidly evolving pathogens with high sequence variability, complex viral antigens, and emerging pathogens. Novel technologies such as nucleic acid and viral vector vaccines offer the potential to revolutionize vaccine development as they are well-suited to address existing technology limitations. In this review, we discuss the current state of RNA vaccines, recombinant adenovirus vector-based vaccines, and advances from biomaterials and engineering that address these important public health challenges.
MeSH term(s)	Adenoviridae/genetics ; Animals ; Antigens, Viral/genetics ; Biocompatible Materials ; COVID-19/prevention & control ; COVID-19/virology ; COVID-19 Vaccines/immunology ; COVID-19 Vaccines/therapeutic use ; Drug Delivery Systems/methods ; Genetic Vectors/immunology ; Humans ; Immunogenicity, Vaccine ; Liposomes ; Nanoparticles ; RNA, Messenger/chemical synthesis ; RNA, Messenger/immunology ; SARS-CoV-2/immunology ; Vaccines, Synthetic/immunology ; Vaccines, Synthetic/therapeutic use ; mRNA Vaccines
Chemical Substances	Antigens, Viral ; Biocompatible Materials ; COVID-19 Vaccines ; Lipid Nanoparticles ; Liposomes ; RNA, Messenger ; Vaccines, Synthetic
Language	English
Publishing date	2021-03-19
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	187009-9
ISSN	1097-4172 ; 0092-8674
ISSN (online)	1097-4172
ISSN	0092-8674
DOI	10.1016/j.cell.2021.02.030
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Article ; Online: mRNA vaccines induce rapid antibody responses in mice.

Gebre, Makda S / Rauch, Susanne / Roth, Nicole / Gergen, Janina / Yu, Jingyou / Liu, Xiaowen / Cole, Andrew C / Mueller, Stefan O / Petsch, Benjamin / Barouch, Dan H

NPJ vaccines

2022 Volume 7, Issue 1, Page(s) 88

Abstract: mRNA vaccines can be developed and produced quickly, making them prime candidates for immediate outbreak responses. Furthermore, clinical trials have demonstrated rapid protection following mRNA vaccination. Thus, we sought to investigate how quickly ... ...

Abstract	mRNA vaccines can be developed and produced quickly, making them prime candidates for immediate outbreak responses. Furthermore, clinical trials have demonstrated rapid protection following mRNA vaccination. Thus, we sought to investigate how quickly mRNA vaccines elicit antibody responses compared to other vaccine modalities. We first compared the immune kinetics of mRNA and DNA vaccines expressing SARS-CoV-2 spike in mice. We observed rapid induction of antigen-specific binding and neutralizing antibodies by day 5 following mRNA (4 µg/mouse), but not DNA (50 µg/mouse), immunization. Comparing innate responses hours post immunization, the mRNA vaccine induced increased levels of IL-5, IL-6, and MCP-1 cytokines which maybe promoting humoral responses downstream. We then evaluated the immune kinetics of an HIV-1 mRNA vaccine in comparison to DNA, protein, and rhesus adenovirus 52 (RhAd52) vaccines of the same HIV-1 envelope antigen in mice. Again, induction of envelope-specific antibodies was observed by day 5 following mRNA vaccination, whereas antibodies were detected by day 7-14 following DNA, protein, and RhAd52 vaccination. Thus, eliciting rapid humoral immunity may be a unique and advantageous property of mRNA vaccines for controlling infectious disease outbreaks.
Language	English
Publishing date	2022-08-01
Publishing country	England
Document type	Journal Article
ISSN	2059-0105
ISSN (online)	2059-0105
DOI	10.1038/s41541-022-00511-y
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Article ; Online: Serum amyloid A (SAA) is an early biomarker of influenza virus disease in BALB/c, C57BL/2, Swiss-Webster, and DBA.2 mice.

Vollmer, Almut H / Gebre, Makda S / Barnard, Dale L

Antiviral research

2016 Volume 133, Page(s) 196–207

Abstract: Assessment of influenza virus disease progression and efficacy of antiviral therapy in the widely used mouse models relies mostly on body weight loss and lung virus titers as markers of disease. However, both parameters have their shortcomings. Therefore, ...

Abstract	Assessment of influenza virus disease progression and efficacy of antiviral therapy in the widely used mouse models relies mostly on body weight loss and lung virus titers as markers of disease. However, both parameters have their shortcomings. Therefore, the aim of our study was to find non-invasive markers in the murine model of severe influenza that could detect disease early and predict disease outcome. BALB/c mice were lethally infected with influenza A(H1N1)pdm09 virus and serum samples were collected at various time points. Enzyme-linked immunosorbent assays were performed to quantify amounts of serum amyloid A (SAA), C-reactive protein, complement 3, transferrin, corticosterone, prostaglandin E2, H2O2, and alpha-2,6-sialyltransferase. We found that SAA was the most promising candidate with levels acutely and temporarily elevated by several hundred-fold 3 days post virus inoculation. Upon treatment with oseltamivir phosphate, levels of SAA were significantly decreased. High levels of SAA were associated with poor disease prognosis, whereas body weight loss was not as a reliable predictor of disease outcome. SAA levels were also transiently increased in BALB/c mice infected with influenza A(H3N2) and influenza B virus, as well as in C57BL/2, Swiss-Webster, and DBA.2 mice infected with influenza A(H1N1)pdm09 virus. High levels of SAA often, but not always, were associated with disease outcome in these other influenza virus mouse models. Therefore, SAA represents a valid biomarker for influenza disease detection in all tested mouse strains but its prognostic value is limited to BALB/c mice infected with influenza A(H1N1)pdm09 virus.
MeSH term(s)	Animals ; Biomarkers ; Cytokines/metabolism ; Disease Models, Animal ; Female ; Alphainfluenzavirus ; Mice ; Mice, Inbred BALB C ; Mice, Inbred C57BL ; Mice, Inbred DBA ; Orthomyxoviridae Infections/blood ; Orthomyxoviridae Infections/diagnosis ; Orthomyxoviridae Infections/mortality ; Orthomyxoviridae Infections/virology ; Serum Amyloid A Protein ; Severity of Illness Index ; Species Specificity ; Viral Load
Chemical Substances	Biomarkers ; Cytokines ; Serum Amyloid A Protein
Language	English
Publishing date	2016-08-11
Publishing country	Netherlands
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	306628-9
ISSN	1872-9096 ; 0166-3542
ISSN (online)	1872-9096
ISSN	0166-3542
DOI	10.1016/j.antiviral.2016.08.011
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Article: Durable Humoral and Cellular Immune Responses Following Ad26.COV2.S Vaccination for COVID-19.

Barouch, Dan H / Stephenson, Kathryn E / Sadoff, Jerald / Yu, Jingyou / Chang, Aiquan / Gebre, Makda / McMahan, Katherine / Liu, Jinyan / Chandrashekar, Abishek / Patel, Shivani / Le Gars, Mathieu / de Groot, Anne Marit / Heerwegh, Dirk / Struyf, Frank / Douoguih, Macaya / van Hoof, Johan / Schuitemaker, Hanneke

medRxiv : the preprint server for health sciences

2021

Abstract: Interim immunogenicity and efficacy data for the Ad26.COV2.S vaccine for COVID-19 have recently ...

Abstract	Interim immunogenicity and efficacy data for the Ad26.COV2.S vaccine for COVID-19 have recently been reported
Language	English
Publishing date	2021-07-07
Publishing country	United States
Document type	Preprint
DOI	10.1101/2021.07.05.21259918
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Article ; Online: Durability and expansion of neutralizing antibody breadth following Ad26.COV2.S vaccination of mice.

Mahrokhian, Shant H / Tostanoski, Lisa H / Jacob-Dolan, Catherine / Zahn, Roland C / Wegmann, Frank / McMahan, Katherine / Yu, Jingyou / Gebre, Makda S / Bondzie, Esther A / Wan, Huahua / Powers, Olivia / Ye, Tianyi / Barrett, Julia / Schuitemaker, Hanneke / Barouch, Dan H

NPJ vaccines

2022 Volume 7, Issue 1, Page(s) 23

Abstract: ... of vaccine-elicited antibodies in humans 8 months following a single immunization with Ad26.COV2.S. Here ... and B.1.351 (beta) variants following a single immunization of Ad26.COV2.S in mice. We report ... postimmunization revealed that Ad26.COV2.S-immunized mice tissues contained spike-specific antibody-secreting cells ...

Abstract	Emerging SARS-CoV-2 variants with the potential to escape binding and neutralizing antibody responses pose a threat to vaccine efficacy. We recently reported expansion of broadly neutralizing activity of vaccine-elicited antibodies in humans 8 months following a single immunization with Ad26.COV2.S. Here, we assessed the 15-month durability of antibody responses and their neutralizing capacity to B.1.617.2 (delta) and B.1.351 (beta) variants following a single immunization of Ad26.COV2.S in mice. We report the persistence of binding and neutralizing antibody titers following immunization with a concomitant increase in neutralizing antibody breadth to delta and beta variants over time. Evaluation of bone marrow and spleen at 15 months postimmunization revealed that Ad26.COV2.S-immunized mice tissues contained spike-specific antibody-secreting cells. We conclude that immunization with Ad26.COV2.S elicits a robust immune response against SARS-CoV-2 spike, which expands over time to neutralize delta and beta variants more robustly, and seeds bone marrow and spleen with long-lived spike-specific antibody-secreting cells. These data extend previous findings in humans and support the use of a mouse model as a potential tool to further explore the dynamics of the humoral immune response following vaccination with Ad26.COV2.S.
Language	English
Publishing date	2022-02-23
Publishing country	England
Document type	Journal Article
ISSN	2059-0105
ISSN (online)	2059-0105
DOI	10.1038/s41541-022-00454-4
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Article ; Online: Deletion of the SARS-CoV-2 Spike Cytoplasmic Tail Increases Infectivity in Pseudovirus Neutralization Assays.

Yu, Jingyou / Li, Zhenfeng / He, Xuan / Gebre, Makda S / Bondzie, Esther A / Wan, Huahua / Jacob-Dolan, Catherine / Martinez, David R / Nkolola, Joseph P / Baric, Ralph S / Barouch, Dan H

Journal of virology

2021 Volume 95, Issue 11

Abstract: ... entry into cells as compared with full-length spike (S). We further compared S and SΔCT13 in terms ...

Abstract	Pseudotyped viruses are valuable tools for studying virulent or lethal viral pathogens that need to be handled in biosafety level 3 (BSL-3) or higher facilities. With the explosive spread of the coronavirus disease 2019 (COVID-19) pandemic, the establishment of a BSL-2 adapted SARS-CoV-2 pseudovirus neutralization assay is needed to facilitate the development of countermeasures. Here we describe an approach to generate a single-round lentiviral vector-based SARS-CoV-2 pseudovirus, which produced a signal more than 2 logs above background. Specifically, a SARS-CoV-2 spike variant with a cytoplasmic tail deletion of 13 amino acids, termed SΔCT13, conferred enhanced spike incorporation into pseudovirions and increased viral entry into cells as compared with full-length spike (S). We further compared S and SΔCT13 in terms of their sensitivity to vaccine sera, purified convalescent IgG, hACE2-mIgG, and the virus entry inhibitor BafA1. We developed a SΔCT13-based pseudovirus neutralization assay and defined key assay characteristics, including linearity, limit of detection, and intra- and intermediate-assay precision. Our data demonstrate that the SΔCT13-based pseudovirus shows enhanced infectivity in target cells, which will facilitate the assessment of humoral immunity to SARS-CoV-2 infection, antibody therapeutics, and vaccination. This pseudovirus neutralization assay can also be readily adapted to SARS-CoV-2 variants that emerge.
Language	English
Publishing date	2021-03-16
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.00044-21
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Zs.A 609: Show issues

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Article: mRNA Vaccines Induce Rapid Antibody Responses in Mice.

Gebre, Makda S / Rauch, Susanne / Roth, Nicole / Gergen, Janina / Yu, Jingyou / Liu, Xiaowen / Cole, Andrew C / Mueller, Stefan O / Petsch, Benjamin / Barouch, Dan H

bioRxiv : the preprint server for biology

2021

Abstract: mRNA vaccines can be developed and produced quickly, making them attractive for immediate outbreak responses. Furthermore, clinical trials have demonstrated rapid protection following mRNA vaccination. We sought to investigate how quickly mRNA vaccines ... ...

Abstract	mRNA vaccines can be developed and produced quickly, making them attractive for immediate outbreak responses. Furthermore, clinical trials have demonstrated rapid protection following mRNA vaccination. We sought to investigate how quickly mRNA vaccines elicit antibody responses compared to other vaccine modalities. We first examined immune kinetics of mRNA and DNA vaccines expressing SARS-CoV-2 spike in mice. We observed rapid induction of antigen-specific binding and neutralizing antibodies by day 5 following mRNA, but not DNA, immunization. The mRNA vaccine also induced increased levels of IL-5, IL-6 and MCP-1. We then evaluated immune kinetics of an HIV-1 mRNA vaccine in comparison to DNA, protein, and rhesus adenovirus 52 (RhAd52) vaccines with the same HIV-1 envelope antigen in mice. Induction of envelope-specific antibodies was observed by day 5 following mRNA vaccination, whereas antibodies were detected by day 7-14 following DNA, protein, and RhAd52 vaccination. Eliciting rapid humoral immunity may be an advantageous property of mRNA vaccines for controlling infectious disease outbreaks. Importance: mRNA vaccines can be developed and produced in record time. Here we demonstrate induction of rapid antibody responses by mRNA vaccines encoding two different viral antigens by day 5 following immunization in mice. The rapid immune kinetics of mRNA vaccines can be an advantageous property that makes them well suited for rapid control of infectious disease outbreaks.
Language	English
Publishing date	2021-11-02
Publishing country	United States
Document type	Preprint
DOI	10.1101/2021.11.01.466863
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Article ; Online: Durable Humoral and Cellular Immune Responses 8 Months after Ad26.COV2.S Vaccination.

Barouch, Dan H / Stephenson, Kathryn E / Sadoff, Jerald / Yu, Jingyou / Chang, Aiquan / Gebre, Makda / McMahan, Katherine / Liu, Jinyan / Chandrashekar, Abishek / Patel, Shivani / Le Gars, Mathieu / de Groot, Anne M / Heerwegh, Dirk / Struyf, Frank / Douoguih, Macaya / van Hoof, Johan / Schuitemaker, Hanneke

The New England journal of medicine

2021 Volume 385, Issue 10, Page(s) 951–953

MeSH term(s)	Ad26COVS1 ; Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; COVID-19 Vaccines/immunology ; Follow-Up Studies ; Humans ; Immunity, Cellular ; Immunity, Humoral ; Immunogenicity, Vaccine ; SARS-CoV-2 ; T-Lymphocytes/physiology ; Vaccination
Chemical Substances	Ad26COVS1 (JT2NS6183B) ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines
Language	English
Publishing date	2021-07-14
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2108829
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Article ; Online: Intranasal vaccination with lipid-conjugated immunogens promotes antigen transmucosal uptake to drive mucosal and systemic immunity.

Hartwell, Brittany L / Melo, Mariane B / Xiao, Peng / Lemnios, Ashley A / Li, Na / Chang, Jason Y H / Yu, Jingyou / Gebre, Makda S / Chang, Aiquan / Maiorino, Laura / Carter, Crystal / Moyer, Tyson J / Dalvie, Neil C / Rodriguez-Aponte, Sergio A / Rodrigues, Kristen A / Silva, Murillo / Suh, Heikyung / Adams, Josetta / Fontenot, Jane /

Love, J Christopher / Barouch, Dan H / Villinger, Francois / Ruprecht, Ruth M / Irvine, Darrell J

Science translational medicine

2022 Volume 14, Issue 654, Page(s) eabn1413

Abstract: To combat the HIV epidemic and emerging threats such as SARS-CoV-2, immunization strategies are needed that elicit protection at mucosal portals of pathogen entry. Immunization directly through airway surfaces is effective in driving mucosal immunity, ... ...

Abstract	To combat the HIV epidemic and emerging threats such as SARS-CoV-2, immunization strategies are needed that elicit protection at mucosal portals of pathogen entry. Immunization directly through airway surfaces is effective in driving mucosal immunity, but poor vaccine uptake across the mucus and epithelial lining is a limitation. The major blood protein albumin is constitutively transcytosed bidirectionally across the airway epithelium through interactions with neonatal Fc receptors (FcRn). Exploiting this biology, here, we demonstrate a strategy of "albumin hitchhiking" to promote mucosal immunity using an intranasal vaccine consisting of protein immunogens modified with an amphiphilic albumin-binding polymer-lipid tail, forming amph-proteins. Amph-proteins persisted in the nasal mucosa of mice and nonhuman primates and exhibited increased uptake into the tissue in an FcRn-dependent manner, leading to enhanced germinal center responses in nasal-associated lymphoid tissue. Intranasal immunization with amph-conjugated HIV Env gp120 or SARS-CoV-2 receptor binding domain (RBD) proteins elicited 100- to 1000-fold higher antigen-specific IgG and IgA titers in the serum, upper and lower respiratory mucosa, and distal genitourinary mucosae of mice compared to unmodified protein. Amph-RBD immunization induced high titers of SARS-CoV-2-neutralizing antibodies in serum, nasal washes, and bronchoalveolar lavage. Furthermore, intranasal amph-protein immunization in rhesus macaques elicited 10-fold higher antigen-specific IgG and IgA responses in the serum and nasal mucosa compared to unmodified protein, supporting the translational potential of this approach. These results suggest that using amph-protein vaccines to deliver antigen across mucosal epithelia is a promising strategy to promote mucosal immunity against HIV, SARS-CoV-2, and other infectious diseases.
MeSH term(s)	Administration, Intranasal ; Albumins ; Animals ; Antibodies, Viral ; COVID-19/prevention & control ; HIV Infections/prevention & control ; Immunity, Mucosal ; Immunoglobulin A ; Immunoglobulin G ; Lipids ; Macaca mulatta ; Mice ; Mice, Inbred BALB C ; SARS-CoV-2 ; Vaccination
Chemical Substances	Albumins ; Antibodies, Viral ; Immunoglobulin A ; Immunoglobulin G ; Lipids
Language	English
Publishing date	2022-07-20
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, N.I.H., Extramural
ZDB-ID	2518854-9
ISSN	1946-6242 ; 1946-6234
ISSN (online)	1946-6242
ISSN	1946-6234
DOI	10.1126/scitranslmed.abn1413
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Article ; Online: Feasibility and safety of ultrasound-guided minimally invasive autopsy in COVID-19 patients.

Brook, Olga R / Piper, Kimberly G / Mercado, Noe B / Gebre, Makda S / Barouch, Dan H / Busman-Sahay, Kathleen / Starke, Carly E / Estes, Jacob D / Martinot, Amanda J / Wrijil, Linda / Ducat, Sarah / Hecht, Jonathan L

Abdominal radiology (New York)

2020 Volume 46, Issue 3, Page(s) 1263–1271

Abstract: Objectives: To determine the feasibility and safety of ultrasound-guided minimally invasive autopsy in COVID-19 patients.: Methods: 60 patients who expired between 04/22/2020-05/06/2020 due to COVID-19 were considered for inclusion in the study, ... ...

Abstract	Objectives: To determine the feasibility and safety of ultrasound-guided minimally invasive autopsy in COVID-19 patients. Methods: 60 patients who expired between 04/22/2020-05/06/2020 due to COVID-19 were considered for inclusion in the study, based on availability of study staff. Minimally invasive ultrasound-guided autopsy was performed with 14G core biopsies through a 13G coaxial needle. The protocol required 20 cores of the liver, 30 of lung, 12 of spleen, 20 of heart, 20 of kidney, 4 of breast, 4 of testis, 2 of skeletal muscle, and 4 of fat with total of 112 cores per patient. Quality of the samples was evaluated by number, size, histology, immunohistochemistry, and in situ hybridization for COVID-19 and PCR-measured viral loads for SARS-CoV-2. Results: Five (5/60, 8%) patients were included. All approached families gave their consent for the minimally invasive autopsy. All organs for biopsy were successfully targeted with ultrasound guidance obtaining all required samples, apart from 2 patients where renal samples were not obtained due to atrophic kidneys. The number, size, and weight of the tissue cores met expectation of the research group and tissue histology quality was excellent. Pathology findings were concordant with previously reported autopsy findings for COVID-19. Highest SARS-CoV-2 viral load was detected in the lung, liver, and spleen that had small to moderate amount, and low viral load in was detected in the heart in 2/5 (40%). No virus was detected in the kidney (0/3, 0%). Conclusions: Ultrasound-guided percutaneous post-mortem core biopsies can safely provide adequate tissue. Highest SARS-CoV-2 viral load was seen in the lung, followed by liver and spleen with small amount in the myocardium.
MeSH term(s)	Aged ; Aged, 80 and over ; Autopsy/methods ; Biopsy ; COVID-19/pathology ; Feasibility Studies ; Female ; Humans ; Male ; Middle Aged ; SARS-CoV-2 ; Ultrasonography, Interventional/methods
Keywords	covid19
Language	English
Publishing date	2020-09-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	2839786-1
ISSN	2366-0058 ; 2366-004X
ISSN (online)	2366-0058
ISSN	2366-004X
DOI	10.1007/s00261-020-02753-7
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