Article
Chemistry, Medicinal
Nitya Sharma, Kaushal Jerajani, Ying Wan, Ozan S. Kumru, Swathi R. Pullagurla, Oluwadara Ogun, Shweta Mapari, Sarah Brendle, Neil D. Christensen, Saurabh Batwal, Mustafa Mahedvi, Harish Rao, Vikas Dogar, Rahul Chandrasekharan, Umesh Shaligram, David B. Volkin, Sangeeta B. Joshi
Summary: This work outlines the development of a multi-dose formulation for a Human Papillomavirus (HPV) Virus-Like Particle (VLP) based vaccine. Storage stability studies identified eight lead candidates for the formulation, with optimal stability and antimicrobial effectiveness observed with certain preservatives.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2023)
Article
Chemistry, Medicinal
Kaushal Jerajani, Ying Wan, John M. Hickey, Ozan S. Kumru, Nitya Sharma, Swathi R. Pullagurla, Oluwadara Ogun, Shweta Mapari, Neal Whitaker, Sarah Brendle, Neil D. Christensen, Saurabh Batwal, Mustafa Mahedvi, Harish Rao, Vikas Dogar, Rahul Chandrasekharan, Umesh Shaligram, Sangeeta B. Joshi, David B. Volkin
Summary: Introducing multi-dose formulations of Human Papillomavirus (HPV) vaccines can reduce costs and improve vaccine coverage globally. This study focuses on the development of key analytical methods for the formulation development of HPV vaccines. The study includes the selection of appropriate physicochemical methods, the characterization of HPV vaccines, the development of stability-indicating competitive ELISA assays, and the evaluation of preservative stability and effectiveness. The results discuss the analytical challenges encountered and highlight the importance of high-throughput methods for the development of aluminum-adjuvanted protein-based vaccine candidates.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2022)
Article
Immunology
Vasilis C. Pliasas, Zach Menne, Virginia Aida, Ji-Hang Yin, Maria C. Naskou, Peter J. Neasham, J. Fletcher North, Dylan Wilson, Katharine A. Horzmann, Joshy Jacob, Ioanna Skountzou, Constantinos S. Kyriakis
Summary: This study evaluated the immunogenicity and efficacy of a novel vaccine against influenza virus infection in a pig model. The results showed that the vaccine induced high levels of anti-NA antibodies and provided protection comparable to a commercial vaccine.
FRONTIERS IN IMMUNOLOGY
(2022)
Review
Biochemistry & Molecular Biology
Raphael P. P. Viscidi, Treva Rowley, Ioannis Bossis
Summary: Recent research has highlighted the important role of tissue-resident memory T cells (T-RM cells) and a subset of dendritic cells in inducing strong protective immune responses. However, effective vaccine technologies that can induce robust CD8+ T cell responses through cross-priming are lacking. Here, we developed a platform technology using genetically engineered bovine papillomavirus virus-like particles (VLPs) that possess self-adjuvant properties. These polyionic VLP vaccines were able to induce robust CD8+ T cell responses in peripheral blood and tumor tissues, and outperformed other vaccines and immunotherapies for the treatment of prostate cancer in a relevant murine model. The immunogenicity of polyionic VLP vaccines depended on particle size, reversible antigen-VLP linkage, and a mechanism involving type 1 interferon and Toll-like receptor (TLR)3/7.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2023)
Article
Engineering, Biomedical
Beom Jeung Hwang, Yohan Jang, Soon Bin Kwon, Ji Eun Yu, Jongkwan Lim, Young Hoon Roh, Baik L. Seong
Summary: Virus-like particles (VLPs) represent a high-priority vaccine platform against emerging viral infections, with RNA and tRNA playing crucial roles in protein folding and antigen assembly.
Article
Immunology
Diana Aguado-Garcia, Alex Olvera, Christian Brander, Victor Sanchez-Merino, Eloisa Yuste
Summary: The long-term storage stability of vaccines is crucial for the success of global immunization programs. This study evaluated the stability of a HIV-1 virus-like particle vaccine prototype and found that it maintained its structural integrity and the recognition of relevant B-cell epitopes for up to three months at 4 and -20 degrees C. Interestingly, even after a week of storage at room temperature, most particles remained intact and preserved their ability to recognize relevant epitopes.
Review
Immunology
Sivakumar S. Moni, Siddig Ibrahim Abdelwahab, Aamena Jabeen, Mohamed Eltaib Elmobark, Duaa Aqaili, Gassem Ghoal, Bassem Oraibi, Abdulla Mohammed Farasani, Ahmed Ali Jerah, Mahdi Mohammed A. Alnajai, Abdul Majeed Hamad Mohammad Alowayni
Summary: This review provides a thorough analysis of the advances in adjuvant research and explores the evolution and effects of various adjuvants. Alum, as the pioneer, laid the foundation for further research and innovation. The transition from traditional alum-based adjuvants to nano formulations reflects the dynamism and potential of vaccine research. Innovations in adjuvant research, particularly the development of nano formulations, hold great promise for improving vaccine efficacy and safety.
Review
Pharmacology & Pharmacy
Cole J. Batty, Mark T. Heise, Eric M. Bachelder, Kristy M. Ainslie
Summary: The COVID-19 pandemic has sparked unprecedented efforts to develop effective and safe vaccines, with hundreds of vaccine candidates proposed and evaluated preclinically. At least 31 candidate vaccines are now in clinical trials, utilizing diverse platforms that have not been approved for human use before.
ADVANCED DRUG DELIVERY REVIEWS
(2021)
Article
Pharmacology & Pharmacy
Kimberly Braz Gomes, Grace Lovia Allotey-Babington, Sucheta D'Sa, Sang-Moo Kang, Martin J. D'Souza
Summary: This study examined the activation status of dendritic cells (DCs) and the innate and adaptive immune responses after exposure to M2e VLP vaccine. Results showed that the M2e VLP microparticle had a strong stimulatory effect on DCs, and the presence of Alhydrogel(R) and MPL-A(R) adjuvants enhanced this effect.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2022)
Article
Immunology
Anne-Cathrine S. Vogt, Lukas Joerg, Byron Martina, Pascal S. Krenger, Xinyue Chang, Andris Zeltins, Monique Vogel, Mona O. Mohsen, Martin F. Bachmann
Summary: Heterologous prime-boost vaccination strategies using mRNA and virus-like particles can induce high levels of antibody responses and may optimize the efficacy and economics of novel vaccine strategies.
FRONTIERS IN IMMUNOLOGY
(2022)
Article
Immunology
Anna Lucia Tornesello, Maria Tagliamonte, Franco M. Buonaguro, Maria Lina Tornesello, Luigi Buonaguro
Summary: Virus-like particles (VLPs) are self-assembled viral protein complexes that mimic the structure of native viruses. They are able to efficiently activate the immune response and hold promise for the development of vaccines against infectious diseases and cancers. VLP-based vaccine formulations have the advantage of incorporating multiple antigens and can be modified without affecting their structure or antigenicity.
Article
Virology
Yu-Hsuan Yang, Ching-Hui Tai, Dayna Cheng, Ya-Fang Wang, Jen-Ren Wang
Summary: In this study, H5N6 virus-like particles (VLPs) were generated and tested for their potential as a broad-spectrum vaccine candidate against H5Nx avian influenza viruses. The results showed that H5N6 VLPs induced higher neutralizing antibody titers and increased production of immune-related cytokines compared to H5+N6 proteins, suggesting that H5N6 VLPs may be a potential vaccine candidate.
Article
Immunology
Nchang'wa Nhumba, Bruno Sunguya
Summary: Cervical cancer is a major health issue in Tanzania, and the HPV vaccine is an effective intervention. However, the uptake of the second dose of the vaccine is low, with factors such as age, attitude, and awareness influencing the uptake.
Review
Immunology
Vartika Srivastava, Kripa N. Nand, Aijaz Ahmad, Ravinder Kumar
Summary: Virus-like particles (VLPs) are ideal for vaccine development and drug delivery due to their noninfectious nature, high density of repeating epitopes, and ability to raise immune responses. Yeast-based platforms have been used to produce VLPs, and this review discusses the advantages, issues, and limitations of this approach. It also compiles a list of yeast-derived VLP-based vaccines currently in use or in clinical trials.
Review
Biotechnology & Applied Microbiology
Saghi Nooraei, Howra Bahrulolum, Zakieh Sadat Hoseini, Camellia Katalani, Abbas Hajizade, Andrew J. Easton, Gholamreza Ahmadian
Summary: Virus-like particles (VLPs) are virus-derived structures without genetic material, able to self-assemble and mimic viruses, utilized in candidate vaccines and successful applications in targeted drug delivery and gene therapy. Modifying the surface of VLPs for increased specificity and longevity in specific cells or tissues may enhance their future use.
JOURNAL OF NANOBIOTECHNOLOGY
(2021)
Article
Biochemical Research Methods
Swathi R. Pullagurla, Prashant Kumar, Oluwadara Ogun, Ozan S. Kumru, Ahd Hamidi, Femke Hoeksema, Christopher Yallop, Julie E. Bines, David B. Volkin, Sangeeta B. Joshi
Summary: This study used linear regression and Arrhenius modeling to predict the real-time stability profiles of a live-virus vaccine. The predictions were validated using high-throughput assays and control groups, and the study concluded with a ranking of the vaccine formulations.
Article
Multidisciplinary Sciences
Neil C. Dalvie, Lisa H. Tostanoski, Sergio A. Rodriguez-Aponte, Kawaljit Kaur, Sakshi Bajoria, Ozan S. Kumru, Amanda J. Martinot, Abishek Chandrashekar, Katherine McMahan, Noe B. Mercado, Jingyou Yu, Aiquan Chang, Victoria M. Giffin, Felix Nampanya, Shivani Patel, Lesley Bowman, Christopher A. Naranjo, Dongsoo Yun, Zach Flinchbaugh, Laurent Pessaint, Renita Brown, Jason Velasco, Elyse Teow, Anthony Cook, Hanne Andersen, Mark G. Lewis, Danielle L. Camp, Judith Maxwell Silverman, Gaurav S. Nagar, Harish D. Rao, Rakesh R. Lothe, Rahul Chandrasekharan, Meghraj P. Rajurkar, Umesh S. Shaligram, Harry Kleanthous, Sangeeta B. Joshi, David B. Volkin, Sumi Biswas, J. Christopher Love, Dan H. Barouch
Summary: Authorized vaccines against SARS-CoV-2 are not widely available in low- and middle-income countries due to supply shortages, high costs, and complex storage requirements. However, a new vaccine candidate using widely available, safe adjuvants has shown promising results in animal trials, eliciting protective immunity and demonstrating the potential benefits of a low-cost modular vaccine platform for SARS-CoV-2 and other variants.
Article
Chemistry, Medicinal
Nitya Sharma, Kaushal Jerajani, Ying Wan, Ozan S. Kumru, Swathi R. Pullagurla, Oluwadara Ogun, Shweta Mapari, Sarah Brendle, Neil D. Christensen, Saurabh Batwal, Mustafa Mahedvi, Harish Rao, Vikas Dogar, Rahul Chandrasekharan, Umesh Shaligram, David B. Volkin, Sangeeta B. Joshi
Summary: This work outlines the development of a multi-dose formulation for a Human Papillomavirus (HPV) Virus-Like Particle (VLP) based vaccine. Storage stability studies identified eight lead candidates for the formulation, with optimal stability and antimicrobial effectiveness observed with certain preservatives.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2023)
Review
Biotechnology & Applied Microbiology
Prashant Kumar, Christopher Bird, David Holland, Sangeeta B. Joshi, David B. Volkin
Summary: This review focuses on the importance of vaccine formulation containing Sabin strains for global polio eradication efforts. These formulations improve vaccine safety and lower costs, allowing for wider use in low- and middle-income countries. The article discusses formulation strategies, such as developing multidose and combination vaccine formats, to reduce costs and enhance immunogenicity.
HUMAN VACCINES & IMMUNOTHERAPEUTICS
(2023)
Article
Multidisciplinary Sciences
Payton A. -B. Weidenbacher, Mrinmoy Sanyal, Natalia Friedland, Shaogeng Tang, Prabhu S. Arunachalam, Mengyun Hu, Ozan S. Kumru, Mary Kate Morris, Jane Fontenot, Lisa Shirreff, Jonathan Do, Ya-Chen Cheng, Gayathri Vasudevan, Mark B. Feinberg, Francois J. Villinger, Carl Hanson, Sangeeta B. Joshi, David B. Volkin, Bali Pulendran, Peter S. Kim
Summary: While the development of COVID-19 vaccines has been successful, there is a need for a globally available vaccine that provides longer-lasting immunity against current and future variants of concern. One potential vaccine candidate is DCFHP, a protein-nanoparticle vaccine formulated with aluminum hydroxide as the adjuvant. It has shown promising results in eliciting potent and durable neutralizing antibodies in non-human primates against known variants and can be produced in large quantities. DCFHP has the potential to be used as a booster vaccine or as a primary vaccine for pediatric use.
NATURE COMMUNICATIONS
(2023)
Article
Chemistry, Medicinal
Sakshi Bajoria, Lorena R. Antunez, Ozan S. Kumru, Mark Klempner, Yang Wang, Lisa A. Cavacini, Sangeeta B. Joshi, David B. Volkin
Summary: This study investigates the feasibility of low-cost, oral passive immunization using secretory IgA antibodies (sIgA) against enterotoxigenic Escherichia coli (ETEC). Different formulations were evaluated for stability during storage and in in vitro digestion models. The results demonstrate the potential of single-vial, liquid formulations of sIgA antibodies for passive immunization after infant feeding.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2023)
Article
Immunology
Ozan S. Kumru, Mrinmoy Sanyal, Natalia Friedland, John M. Hickey, Richa Joshi, Payton Weidenbacher, Jonathan Do, Ya-Chen Cheng, Peter S. Kim, Sangeeta B. Joshi, David B. Volkin
Summary: This study investigated the formulation and comparability of a self-assembled SARS-CoV-2 spike ferritin nanoparticle vaccine antigen with an aluminum-salt adjuvant. The adjuvanted formulation showed enhanced pseudovirus neutralization titers and differed in their in vitro stability properties. The DCFHP antigen produced in two different cell lines displayed expected differences in glycoforms but showed similar key quality attributes. These findings support the future development of an AH-adjuvanted DCFHP vaccine candidate.
Editorial Material
Biochemical Research Methods
Prashant Kumar, Vibhuti Agrahari
Correction
Multidisciplinary Sciences
Payton A. -B. Weidenbacher, Mrinmoy Sanyal, Natalia Friedland, Shaogeng Tang, Prabhu S. Arunachalam, Mengyun Hu, Ozan S. Kumru, Mary Kate Morris, Jane Fontenot, Lisa Shirreff, Jonathan Do, Ya-Chen Cheng, Gayathri Vasudevan, Mark B. Feinberg, Francois J. Villinger, Carl Hanson, Sangeeta B. Joshi, David B. Volkin, Bali Pulendran, Peter S. Kim
NATURE COMMUNICATIONS
(2023)