A whole virion vaccine for COVID-19 produced via a novel inactivation method: results from animal challenge model studies (original) (raw)
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2021
BackgroundA novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in the Chinese capital Wuhan in 2019. Since late 2019, SARS-CoV-2 has been responsible for a global pandemic that has resulted in 205,338,159 confirmed cases of infection and 4,333,094 deaths as of August 11, 2021, according to the World Health Organization. Currently, there are no approved antiviral drugs and vaccines against SARS-CoV-2. Several strategies to develop SARS-CoV-2 vaccines rely on different technologies such as DNA- and RNA-based formulations, recombinant subunits with viral particles, viral vectors, and purified inactivated viral formulations with or without adjuvant. MethodHere we report the development of an inactivated SARS-CoV-2 vaccine candidate and show that its efficacy and safety in preclinical studies warrant further clinical evaluation. For this purpose, a vaccine candidate was manufactured by using microcarrier based cell culture methods in a disposable wav...
2022
A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in the Chinese capital Wuhan in 2019. Since late 2019, SARS-CoV-2 has been responsible for a global pandemic that has resulted in 405,961,201 con rmed cases of infection and 5,789,567 deaths as of February 11, 2022, according to the World Health Organization (WHO). Here we report the development of an inactivated SARS-CoV-2 vaccine candidate and show that its e cacy and safety in preclinical studies warrant further clinical evaluation. E ciency and possible side effects of vaccine candidate on different doses were evaluated using histopathology, K18 hACE2 transgenic mice challenge, T-cell response, and serum neutralization test in Balb/c mice. All pilot production and propagation experiments of SARS-CoV-2 were performed in the Level 3 Negative Pressure Biosafety Facility (BSL3/ABSL-3) according to COVID-19 interim guidance of WHO. All analytical studies have shown that the quality control parameters of the vaccine candidate meet the requirements for inactivated viral vaccines according to European Pharmacopeia. Vaccine candidate (KOCAK-19) has been authorized by the Turkish Medicines and Medical Devices Agency and has now entered phase 2 clinical development (NCT04838080). Recently, new SARS-CoV-2 variants have emerged and are circulating globally. Most of these variants acquired new mutations in their surface protein (Spike) [A]. Variants with several S mutations have been detected in Brazil, Denmark, South Africa, the UK, and the USA. Four SARS-CoV-2 variants of concern including B.
Development of an Inactivated Vaccine against SARS CoV-2
Vaccines
The rapid spread of SARS-CoV-2 with its mutating strains has posed a global threat to safety during this COVID-19 pandemic. Thus far, there are 123 candidate vaccines in human clinical trials and more than 190 candidates in preclinical development worldwide as per the WHO on 1 October 2021. The various types of vaccines that are currently approved for emergency use include viral vectors (e.g., adenovirus, University of Oxford/AstraZeneca, Gamaleya Sputnik V, and Johnson & Johnson), mRNA (Moderna and Pfizer-BioNTech), and whole inactivated (Sinovac Biotech and Sinopharm) vaccines. Amidst the emerging cases and shortages of vaccines for global distribution, it is vital to develop a vaccine candidate that recapitulates the severe and fatal progression of COVID-19 and further helps to cope with the current outbreak. Hence, we present the preclinical immunogenicity, protective efficacy, and safety evaluation of a whole-virion inactivated SARS-CoV-2 vaccine candidate (ERUCoV-VAC) formulat...
Development and preclinical evaluation of virus‐like particle vaccine against COVID‐19 infection
Allergy, 2021
Background: Vaccines that incorporate multiple SARS-CoV-2 antigens can further broaden the breadth of virus-specific cellular and humoral immunity. This study describes the development and immunogenicity of SARS-CoV-2 VLP vaccine that incorporates the four structural proteins of SARS-CoV-2. 2 | YILMAZ et AL. 1 | INTRODUC TI ON Rapid development of effective vaccines is indispensable in constraining the COVID-19 pandemic. Multiple highly effective COVID-19 vaccines have recently been approved for human use and several are still in clinical development. 1 The majority of current SARS-CoV-2 vaccines target only the Spike (S) antigen with the main intent of eliciting neutralizing antibodies against the receptorbinding domain (RBD) to neutralize infection. 2-6 However, the emergence of variants of concern Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), and Delta (B.1.617.2) with altered S sequences raises concerns on dependence on S-based vaccines, particularly in light of recent evidence indicating the potential for variants to at least partially escape from neutralizing antibodies. 7-18 Although Ankara, Turkey.
Recent Updates on COVID-19 Vaccine Platforms and Its Immunological Aspects: A Review
2020
SARS-CoV-2 firstly emerged in China and sporadically transmitted worldwide. In March 2020, WHO announced that the infection was a pandemic. The outbreak and rapid transmission of COVID-19 have endangered the global health and the economy. This crisis has called for an extensive scientific mobilization of studies on SARS-CoV-2 concerning its clinical aspects, characteristics, and its mechanism of transmission. Although many scientists have published the treatment options against COVID-19, currently, there is not any approved medications against the virus yet. COVID-19 vaccine development has started in many research centers and pharmaceutical industries following the announcement of the agent and the full genome of SARS-CoV-2 recognized. Recently, the collected data described that COVID-19 vaccine candidates grouped into the following types: protein-based, epitope, inactivated or live-attenuated virus, virus-like particle, nucleic acid-based, and viral vectors. Therefore, the present...
2019
Since the reemergence of a severe acute respiratory syndrome caused by a novel coronavirus (SARS-CoV-2), the disease caused by this virus, known as COVID-19, has been spreading rapidly all around the world. As of early June 2020, COVID-19 has infected more that 6.6 million people, and has caused more than 390,000 deaths, globally. Similar to its pioneers, namely SARS-CoV and MERS-CoV, there is currently no vaccine or specific antiviral treatment against this virus. This review provides a timely overview on efforts as well as different platforms used for developing an effective vaccine against COVID-19.
Overview of COVID-19 Vaccine Development Strategy
Bioscientia medicina, 2022
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the cause of coronavirus disease 20019 (COVID19) pandemic which first emerged in December 2019 in Wuhan city, China. Currently, a vaccine is urgently needed to control the COVID-19 pandemic. Several vaccine candidates are under development and some are in the final stage of clinical trials. The COVID-19 vaccination aims to reduce morbidity and mortality rates, achieve herd immunity to prevent and protect the society, strengthen the health system, maintain productivity and minimize social and economic impacts. Before approval, vaccines have to undergo several clinical trials to ensure its safety profile, efficacy, duration of immune system resistance, and adverse effect. Various strategies have been used in the development of vaccines including viral vector vaccines, nucleic acid vaccines, inactivated virus, live attenuated virus, subunit protein¸and virus-like particle vaccine. Each strategy has its own advantages and disadvantages.
An overview of vaccine development for COVID-19
Therapeutic Delivery, 2021
The COVID-19 pandemic continues to endanger world health and the economy. The causative SARS-CoV-2 coronavirus has a unique replication system. The end point of the COVID-19 pandemic is either herd immunity or widespread availability of an effective vaccine. Multiple candidate vaccines – peptide, virus-like particle, viral vectors (replicating and nonreplicating), nucleic acids (DNA or RNA), live attenuated virus, recombinant designed proteins and inactivated virus – are presently under various stages of expansion, and a small number of vaccine candidates have progressed into clinical phases. At the time of writing, three major pharmaceutical companies, namely Pfizer and Moderna, have their vaccines under mass production and administered to the public. This review aims to investigate the most critical vaccines developed for COVID-19 to date.
Challenges and Progress in Vaccine Development for COVID-19 Coronavirus (SARS-CoV-2): A Review
The Open COVID Journal
Coronavirus Infectious Disease (COVID-19) has taken heavy toll on human lives and world economy across the globe. Till date, there is no specific treatment and pathological effects in COVID-19 are continuously evolving. The governments and authorities have announced various measures for personal care with use of face masks, physical distancing and prohibition of mass gatherings. These measures have certainly helped to contain the disease but with substantial economic slowdown. Thus mass immunization by vaccination is the top priority. With knowledge of MERS-SARS (Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome) in hand, researchers are rushing to vaccine development against SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) with newer technological platforms. However, the challenge lies in proving safety, quality and efficacy of vaccine with its resilience to manufacture it in large scales within stipulated time frame. The time consuming nature of cl...
Vaccines
It has been reported that the novel coronavirus (COVID-19) has caused more than 286 million cases and 5.4 million deaths to date. Several strategies have been implemented globally, such as social distancing and the development of the vaccines. Several severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants have appeared, such as Alpha, Beta, Gamma, Delta, and Omicron. With the rapid spread of the novel coronavirus and the rapidly changing mutants, the development of a broad-spectrum multivalent vaccine is considered to be the most effective way to defend against the constantly mutating virus. Here, we evaluated the immunogenicity of the multivalent COVID-19 inactivated vaccine. Mice were immunized by multivalent COVID-19 inactivated vaccine, and the neutralizing antibodies in serum were analyzed. The results show that HB02 + Delta + Omicron trivalent vaccine could provide broad spectrum protection against HB02, Beta, Delta, and Omicron virus. Additionally, the differen...