HJBR Jan/Feb 2021

32 JAN / FEB 2021  I  HEALTHCARE JOURNAL OF BATON ROUGE COVID-19 VACCINE 2.0 studies have demonstrated the feasibility of formulating S protein, RBD domain, M protein and N protein with specific adju- vants. It should be noted that the development of a COVID-19 vaccine has been on a fast track. Thus far, four non-replicating viral vector vaccines, three inactivated vac- cines and two mRNA vaccines being un- der clinical phase III stage, with more are on the way (32). Though different types of adjuvants have been used in exploratory and pre-clinical studies (Tables 1–3), con- sidering the need for rapid deployment of COVID-19 vaccines for the pandemic, alum, which had been formulated in many other licensed vaccines, have been priori- tized (15, 16). In addition to the adjuvants described above, engineered nanomateri- als also shed light adjuvant development. It has been shown that physicochemical characteristics of aluminum oxyhydroxide could affect the optimal immunogenicity profiles of vaccine formulations (41, 83, 84). Moreover, a recent study has shown that an alum-stabilized Pickering emulsion (PAPE) showed robust RBD-specific IgG1 and Ig- G2a titers and a high level of inducing IFN- γ-secreting T cells in a COVID-19 vaccine. Additionally, it has been shown that a natu- ral and potent STING agonist encapsulated by pulmonary biomimetic liposomes trig- gered rapid humoral and cellular immune responses and exhibited a sustained cross- protection against influenza (76). However, more comprehensive mechanistic studies, including the nature of protective immune responses and screening of the various combinations of antigens and adjuvants, are needed for the successful development of a safe and effective COVID-19 vaccine. n Front. Immunol., 06 November 2020 | https://doi.org/10.3389/ fimmu.2020.589833 References available at URL above. © 2020 Liang, Zhu, Wang, Jing, Li, Xia, Sun, Yang, Zhang, Shi, Zeng and Sun. This is an open-access article distrib- uted under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the origi- nal publication Frontiers in Immunology is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Baptist Health Center for Clinical Re- search in Arkansas is one of the first sites in the U.S. to study a novel COVID prevention agent, using two monoclonal antibodies in- stead of a vaccine. “This monoclonal anti- body could be an alternative to a COVID-19 vaccine or could be complementary since we hope the monoclonal antibodies confer immunity almost immediately whereas vac- cines take several weeks,” says Richard G. Pellegrino, MD, PhD, CEO and President of Baptist Health Center for Clinical Research. “There will be around 100 sites total. How- ever, we were amongst the first to open for enrollment. The order of opening sites is determined by the capability. The most important thing, was our ability to combine the speed and service of a privately owned research site with the resources of an inte- grated medical system.” Baptist Health Center for Clinical Re- search’s study coincides with a broader nationwide effort, Operation Warp Speed, which was announced in May as a public- private partnership to facilitate, at an un- precedented pace, the development, man- ufacturing and distribution of COVID-19 measures including vaccines, diagnostics and treatments. “The study lasts for one year,” Pellegrino said, “however, as with the vaccine studies, there is an indepen- dent safety board that looks at the data at Baptist Health Center for Clinical Research Among First Sites in U.S. to Study Novel COVID Prevention Agent predetermined in- tervals. If it is over- whelmingly positive and appears safe, the company [As- traZeneca] can ap- ply for emergency use approval and the monoclonal an- tibody may become available earlier. In any case, the study would continue. Pellegrino’s trial is not a vaccine or an ad- juvant, which are only used with vaccines; in- stead, the antibodies bind to the SARS-Cov2 spike protein and prevent it from replicating and thereby prevent disease. “Subjects will not be exposed to COVID-19,” he contin- ued, “67% of participants will receive an in- tramuscular injection of the antibodies, 33% will receive placebo. They will then compare the number of people in each group who contract COVID-19 naturally, hoping that less people in the treated group will con- tract COVID-19.” More Information including how to par- ticipate is available at arkansascovidvaccine. com. Participants will be compensated for time and travel if they qualify and enroll in the study. Study-related care is provided at no cost and health insurance is not required nor needed. n by Philip Gatto