Browsing by Subject "COVID-19 Vaccines"
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Item Open Access A genetically engineered, stem-cell-derived cellular vaccine.(Cell reports. Medicine, 2022-12) Cooper, Amanda; Sidaway, Adam; Chandrashekar, Abishek; Latta, Elizabeth; Chakraborty, Krishnendu; Yu, Jingyou; McMahan, Katherine; Giffin, Victoria; Manickam, Cordelia; Kroll, Kyle; Mosher, Matthew; Reeves, R Keith; Gam, Rihab; Arthofer, Elisa; Choudhry, Modassir; Henley, Tom; Barouch, Dan HDespite rapid clinical translation of COVID-19 vaccines in response to the global pandemic, an opportunity remains for vaccine technology innovation to address current limitations and meet challenges of inevitable future pandemics. We describe a universal vaccine cell (UVC) genetically engineered to mimic natural physiological immunity induced upon viral infection of host cells. Cells engineered to express the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike as a representative viral antigen induce robust neutralizing antibodies in immunized non-human primates. Similar titers generated in this established non-human primate (NHP) model have translated into protective human neutralizing antibody levels in SARS-CoV-2-vaccinated individuals. Animals vaccinated with ancestral spike antigens and subsequently challenged with SARS-CoV-2 Delta variant in a heterologous challenge have an approximately 3 log decrease in viral subgenomic RNA in the lungs. This cellular vaccine is designed as a scalable cell line with a modular poly-antigenic payload, allowing for rapid, large-scale clinical manufacturing and use in an evolving viral variant environment.Item Open Access COVID-19 vaccination intention and activation among health care system employees: A mixed methods study.(Vaccine, 2022-08) Vasudevan, Lavanya; Bruening, Rebecca; Hung, Anna; Woolson, Sandra; Brown, Adrian; Hastings, Susan N; Linton, Tammy; Embree, Genevieve; Hostler, Christopher J; Mahanna, Elizabeth; Okeke, Nwora Lance; Bosworth, Hayden; Sperber, Nina RBackground
Achieving high COVID-19 vaccination rates among employees is necessary to prevent outbreaks in health care settings. The goal of the study was to produce actionable and timely evidence about factors underlying the intention and decisions to obtain the COVID-19 vaccine by employees.Methods
The study was conducted from December 2020 - May 2021 with employees from a VA health care system in Southeastern US. The study used a convergent mixed methods design comprising two main activities: a cross-sectional survey conducted prior to COVID-19 vaccine distribution, and semi-structured interviews conducted 4-6 months after vaccine distribution. Data were collected about participant characteristics, vaccination intention prior to distribution, vaccination decision post-distribution, determinants of vaccination intention and decision, activating factors, sources of information and intervention needs. Data from the survey and interviews were analyzed separately and integrated narratively in the discussion.Results
Prior to vaccine distribution, 77% of employees wanted to be vaccinated. Post vaccine distribution, we identified 5 distinct decision-making groups: 1) vaccine believers who actively sought vaccination and included those sometimes described as "immunization advocates", 2) go along to get along (GATGA) individuals who got vaccinated but did not actively seek it, 3) cautious acceptors who got the COVID-19 vaccine after some delay, 4) fence sitters who remained uncertain about getting vaccinated, and 5) vaccine refusers who actively rejected the COVID-19 vaccine. Participants identifying with Black or multiple races were more likely to express hesitancy in their vaccination intention.Conclusion
The findings of our study highlight distinct decision-making profiles associated with COVID-19 vaccination among employees of a VA health care system, and provide tailored recommendations to reduce vaccine hesitancy in this population.Item Open Access Exosomes decorated with a recombinant SARS-CoV-2 receptor-binding domain as an inhalable COVID-19 vaccine.(Nature biomedical engineering, 2022-07-04) Wang, Zhenzhen; Popowski, Kristen D; Zhu, Dashuai; de Juan Abad, Blanca López; Wang, Xianyun; Liu, Mengrui; Lutz, Halle; De Naeyer, Nicole; DeMarco, C Todd; Denny, Thomas N; Dinh, Phuong-Uyen C; Li, Zhenhua; Cheng, KeThe first two mRNA vaccines against infection by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that were approved by regulators require a cold chain and were designed to elicit systemic immunity via intramuscular injection. Here we report the design and preclinical testing of an inhalable virus-like-particle as a COVID-19 vaccine that, after lyophilisation, is stable at room temperature for over three months. The vaccine consists of a recombinant SARS-CoV-2 receptor-binding domain (RBD) conjugated to lung-derived exosomes which, with respect to liposomes, enhance the retention of the RBD in both the mucus-lined respiratory airway and in lung parenchyma. In mice, the vaccine elicited RBD-specific IgG antibodies, mucosal IgA responses and CD4+ and CD8+ T cells with a Th1-like cytokine expression profile in the animals' lungs, and cleared them of SARS-CoV-2 pseudovirus after a challenge. In hamsters, two doses of the vaccine attenuated severe pneumonia and reduced inflammatory infiltrates after a challenge with live SARS-CoV-2. Inhalable and room-temperature-stable virus-like particles may become promising vaccine candidates.Item Open Access Host range, transmissibility and antigenicity of a pangolin coronavirus.(Nature microbiology, 2023-10) Hou, Yixuan J; Chiba, Shiho; Leist, Sarah R; Meganck, Rita M; Martinez, David R; Schäfer, Alexandra; Catanzaro, Nicholas J; Sontake, Vishwaraj; West, Ande; Edwards, Catlin E; Yount, Boyd; Lee, Rhianna E; Gallant, Samuel C; Zost, Seth J; Powers, John; Adams, Lily; Kong, Edgar F; Mattocks, Melissa; Tata, Aleksandra; Randell, Scott H; Tata, Purushothama R; Halfmann, Peter; Crowe, James E; Kawaoka, Yoshihiro; Baric, Ralph SThe pathogenic and cross-species transmission potential of SARS-CoV-2-related coronaviruses (CoVs) remain poorly characterized. Here we recovered a wild-type pangolin (Pg) CoV GD strain including derivatives encoding reporter genes using reverse genetics. In primary human cells, PgCoV replicated efficiently but with reduced fitness and showed less efficient transmission via airborne route compared with SARS-CoV-2 in hamsters. PgCoV was potently inhibited by US Food and Drug Administration approved drugs, and neutralized by COVID-19 patient sera and SARS-CoV-2 therapeutic antibodies in vitro. A pan-Sarbecovirus antibody and SARS-CoV-2 S2P recombinant protein vaccine protected BALB/c mice from PgCoV infection. In K18-hACE2 mice, PgCoV infection caused severe clinical disease, but mice were protected by a SARS-CoV-2 human antibody. Efficient PgCoV replication in primary human cells and hACE2 mice, coupled with a capacity for airborne spread, highlights an emergence potential. However, low competitive fitness, pre-immune humans and the benefit of COVID-19 countermeasures should impede its ability to spread globally in human populations.Item Open Access Mitigation behavior prior to COVID-19 vaccination availability is associated with COVID-19 infection and time to vaccination.(PloS one, 2023-01) Neighbors, Coralei E; Sloane, Richard; Pieper, Carl F; Wixted, Douglas; Woods, Christopher W; Newby, L KristinBackground
Mitigation behaviors reduce the incidence of COVID-19 infection. Determining characteristics of groups defined by mitigation behaviors compliance may be useful to inform targeted public health policies and interventions. This study aimed to identify groups of individuals according to self-reported compliance with COVID-19 mitigation behaviors, define compliance class characteristics, and explore associations between compliance classes and important study and public health outcomes.Methods and findings
We studied 1,410 participants in the Cabarrus County COVID-19 Prevalence and Immunity longitudinal cohort study (June 2020 to December 2021) who were asked 10 questions regarding compliance with recommended COVID-19 mitigation behaviors. By Latent Class Analysis, 1,381 participants were categorized into 3 classes (most [49.4%], moderately [45.0%], and least [5.6%] compliant). Compared with the most compliant class, the least and moderately compliant classes were younger (mean = 61.9 v. 59.0 v. 53.8 years), had fewer medical conditions per individual (1.37 v. 1.08 v. 0.77), and differed in Hispanic ethnicity (6.2% v. 2.8% v. 9.1%) and COVID-19 vaccine intention (65.8% v. 59.8% v. 35.1%). Compared to the most compliant class, the least compliant class had fewer women (54.6% v. 76.3%), fewer insured individuals (92.2% v. 97.4%), and more withdrew from study participation early (28.6% v. 16.0%). Relative to the most compliant class, the least compliant class had a higher likelihood of COVID-19 infection (OR = 2.08 [95% CI 1.13, 3.85]), lower rate of COVID-19 vaccination (72.6% v. 95.1%), and longer time to 50% COVID-19 vaccination following eligibility (8-9 vs 16 days).Conclusions
Classes defined by mitigation behaviors compliance had distinct characteristics, including age, sex, medical history, and ethnicity, and were associated with important study and public health outcomes. Targeted public health policies and interventions according to the compliance group characteristics may be of value in current and future pandemic responses to increase compliance.Item Open Access Neutralizing antibody vaccine for pandemic and pre-emergent coronaviruses.(Nature, 2021-06) Saunders, Kevin O; Lee, Esther; Parks, Robert; Martinez, David R; Li, Dapeng; Chen, Haiyan; Edwards, Robert J; Gobeil, Sophie; Barr, Maggie; Mansouri, Katayoun; Alam, S Munir; Sutherland, Laura L; Cai, Fangping; Sanzone, Aja M; Berry, Madison; Manne, Kartik; Bock, Kevin W; Minai, Mahnaz; Nagata, Bianca M; Kapingidza, Anyway B; Azoitei, Mihai; Tse, Longping V; Scobey, Trevor D; Spreng, Rachel L; Rountree, R Wes; DeMarco, C Todd; Denny, Thomas N; Woods, Christopher W; Petzold, Elizabeth W; Tang, Juanjie; Oguin, Thomas H; Sempowski, Gregory D; Gagne, Matthew; Douek, Daniel C; Tomai, Mark A; Fox, Christopher B; Seder, Robert; Wiehe, Kevin; Weissman, Drew; Pardi, Norbert; Golding, Hana; Khurana, Surender; Acharya, Priyamvada; Andersen, Hanne; Lewis, Mark G; Moore, Ian N; Montefiori, David C; Baric, Ralph S; Haynes, Barton FBetacoronaviruses caused the outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome, as well as the current pandemic of SARS coronavirus 2 (SARS-CoV-2)1-4. Vaccines that elicit protective immunity against SARS-CoV-2 and betacoronaviruses that circulate in animals have the potential to prevent future pandemics. Here we show that the immunization of macaques with nanoparticles conjugated with the receptor-binding domain of SARS-CoV-2, and adjuvanted with 3M-052 and alum, elicits cross-neutralizing antibody responses against bat coronaviruses, SARS-CoV and SARS-CoV-2 (including the B.1.1.7, P.1 and B.1.351 variants). Vaccination of macaques with these nanoparticles resulted in a 50% inhibitory reciprocal serum dilution (ID50) neutralization titre of 47,216 (geometric mean) for SARS-CoV-2, as well as in protection against SARS-CoV-2 in the upper and lower respiratory tracts. Nucleoside-modified mRNAs that encode a stabilized transmembrane spike or monomeric receptor-binding domain also induced cross-neutralizing antibody responses against SARS-CoV and bat coronaviruses, albeit at lower titres than achieved with the nanoparticles. These results demonstrate that current mRNA-based vaccines may provide some protection from future outbreaks of zoonotic betacoronaviruses, and provide a multimeric protein platform for the further development of vaccines against multiple (or all) betacoronaviruses.Item Open Access Next-Generation Vaccine Development with Nanomaterials: Recent Advances, Possibilities, and Challenges.(Annual review of biomedical engineering, 2024-07) Shetty, Shamitha; Alvarado, Pablo Cordero; Pettie, Deleah; Collier, Joel HNanomaterials are becoming important tools for vaccine development owing to their tunable and adaptable nature. Unique properties of nanomaterials afford opportunities to modulate trafficking through various tissues, complement or augment adjuvant activities, and specify antigen valency and display. This versatility has enabled recent work designing nanomaterial vaccines for a broad range of diseases, including cancer, inflammatory diseases, and various infectious diseases. Recent successes of nanoparticle vaccines during the coronavirus disease 2019 (COVID-19) pandemic have fueled enthusiasm further. In this review, the most recent developments in nanovaccines for infectious disease, cancer, inflammatory diseases, allergic diseases, and nanoadjuvants are summarized. Additionally, challenges and opportunities for clinical translation of this unique class of materials are discussed.Item Open Access Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques.(Nature, 2020-10) Mercado, Noe B; Zahn, Roland; Wegmann, Frank; Loos, Carolin; Chandrashekar, Abishek; Yu, Jingyou; Liu, Jinyan; Peter, Lauren; McMahan, Katherine; Tostanoski, Lisa H; He, Xuan; Martinez, David R; Rutten, Lucy; Bos, Rinke; van Manen, Danielle; Vellinga, Jort; Custers, Jerome; Langedijk, Johannes P; Kwaks, Ted; Bakkers, Mark JG; Zuijdgeest, David; Rosendahl Huber, Sietske K; Atyeo, Caroline; Fischinger, Stephanie; Burke, John S; Feldman, Jared; Hauser, Blake M; Caradonna, Timothy M; Bondzie, Esther A; Dagotto, Gabriel; Gebre, Makda S; Hoffman, Emily; Jacob-Dolan, Catherine; Kirilova, Marinela; Li, Zhenfeng; Lin, Zijin; Mahrokhian, Shant H; Maxfield, Lori F; Nampanya, Felix; Nityanandam, Ramya; Nkolola, Joseph P; Patel, Shivani; Ventura, John D; Verrington, Kaylee; Wan, Huahua; Pessaint, Laurent; Van Ry, Alex; Blade, Kelvin; Strasbaugh, Amanda; Cabus, Mehtap; Brown, Renita; Cook, Anthony; Zouantchangadou, Serge; Teow, Elyse; Andersen, Hanne; Lewis, Mark G; Cai, Yongfei; Chen, Bing; Schmidt, Aaron G; Reeves, R Keith; Baric, Ralph S; Lauffenburger, Douglas A; Alter, Galit; Stoffels, Paul; Mammen, Mathai; Van Hoof, Johan; Schuitemaker, Hanneke; Barouch, Dan HA safe and effective vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may be required to end the coronavirus disease 2019 (COVID-19) pandemic1-8. For global deployment and pandemic control, a vaccine that requires only a single immunization would be optimal. Here we show the immunogenicity and protective efficacy of a single dose of adenovirus serotype 26 (Ad26) vector-based vaccines expressing the SARS-CoV-2 spike (S) protein in non-human primates. Fifty-two rhesus macaques (Macaca mulatta) were immunized with Ad26 vectors that encoded S variants or sham control, and then challenged with SARS-CoV-2 by the intranasal and intratracheal routes9,10. The optimal Ad26 vaccine induced robust neutralizing antibody responses and provided complete or near-complete protection in bronchoalveolar lavage and nasal swabs after SARS-CoV-2 challenge. Titres of vaccine-elicited neutralizing antibodies correlated with protective efficacy, suggesting an immune correlate of protection. These data demonstrate robust single-shot vaccine protection against SARS-CoV-2 in non-human primates. The optimal Ad26 vector-based vaccine for SARS-CoV-2, termed Ad26.COV2.S, is currently being evaluated in clinical trials.