Immunogenicity and Safety Profile of COVID-19 Vaccines- A Systematic Review (Preprint)

2020 ◽  
Author(s):  
Reeju Maharjan ◽  
Aditya Bamboria ◽  
Neelam Asghar ◽  
Manish Shrestha ◽  
Syed W H Rizvi
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Systematic Reviews ◽  
Neutralizing Antibodies ◽  
Phase Iii ◽  
Effective Vaccine ◽  
Efficacy And Safety ◽  
Vaccine Candidates ◽  
One Year ◽  
Meta Analyses

BACKGROUND An effective vaccine will be important in controlling severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. OBJECTIVE In this study, we aim to analyze the degree of immunogenicity that rises after administering different vaccines, and to study their efficacy. METHODS We systematically reviewed multiple vaccine candidates at different stages of clinical trials to prevent Coronavirus disease in 2019 (COVID-19). We reviewed literature from four major electronic databases (PubMed, MEDLINE, PubMed Central, and Google scholar) to identify studies on SARS-CoV-2 vaccine candidates. This article included studies that include clinical trials in multiple stages and systematic reviews published in 2020. We performed a quality assessment with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for our articles. RESULTS We included a total of 19 articles. This review article has a total of 24,342 individuals. These studies show promising results regarding vaccines candidates, safety profiles, and immunogenicity with the effective generation of neutralizing antibodies and specific T-cell responses. Adverse effects range from mild to moderate, with no serious adverse effects reported. It is unclear how long the generated immunity will last, and a follow up of the study participants for an extended one-year period will be needed. CONCLUSIONS Ascertaining vaccines' efficacy and safety in vulnerable populations is essential for the general use of vaccine use. A number of these vaccines are currently under phase III or to enter phase III and may increase vaccines' efficacy and safety in different populations.

Efficacy and Safety of AZD1222, BNT162b2 and mRNA-1273 vaccines against SARS-CoV-2

2021 ◽  
Vol 5 (1) ◽  
pp. 791-796
Author(s):  
Ilir Alimehmeti
Keyword(s):  
Clinical Trials ◽  
Diagnostic Tests ◽  
Web Of Science ◽  
Rapid Development ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Vaccine Candidates ◽  
Genetic Sequence ◽  
Phase Iii Clinical Trials ◽  
Clinical Trial Results

SARS-CoV-2, the beta coronavirus causing COVID-19, was isolated and categorizes as a novel one on January 7th, 2020 in China.[1] To date, official reports depict that SARS-CoV-2 has already infected 88.828.387 persons and caused 1.926.625 deaths worldwide.[2] On January 12th, 2020, China officials made public its genetic sequence, thus paving the way towards the research and development of diagnostic tests and vaccines. With regard to vaccination, e large number of clinical trials were designed and are currently undergoing, of which 189 are listed in ClinicalTrials.gov. [3] However, up to date, only three vaccines have published their respective phase III clinical trial results in peer-reviewed medical journals. [4-6] Vaccines are needed to reduce the morbidity and mortality associated with Covid-19, and multiple vaccine platforms as AZD1222 (AstraZeneca) [4], BNT162b2 (Pfizer/BioNTech) [5] and mRNA-1273 (Moderna) have been involved in the rapid development of vaccine candidates. Methodology: In this review, PubMed, Embase, Web of Science, Scopus, medRxiv, and bioRxiv were systematically scrutinized for peer-reviewed and preprint articles on phase III clinical trials of vaccines against SARS-CoV-2. In total, only three peer-reviewed papers fulfilling the search criteria were identified. Conclusions; All vaccine candidates should publish in peer-reviewed journals their efficacy and safety well before requesting approval to the national or international authorities…

scholarly journals COVID-19: Insights into Potential Vaccines

2021 ◽  
Vol 9 (3) ◽  
pp. 605
Author(s):  
Ke-Yan Loo ◽  
Vengadesh Letchumanan ◽  
Hooi-Leng Ser ◽  
Siew Li Teoh ◽  
Jodi Woan-Fei Law ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Viral Vector ◽  
Phase Iii ◽  
Effective Vaccine ◽  
Pharmaceutical Companies ◽  
Protein Subunit ◽  
Subunit Vaccines ◽  
Vaccine Candidates ◽  
Phase Iii Clinical Trials ◽  
Positive Results

People around the world ushered in the new year 2021 with a fear of COVID-19, as family members have lost their loved ones to the disease. Millions of people have been infected, and the livelihood of many has been jeopardized due to the pandemic. Pharmaceutical companies are racing against time to develop an effective vaccine to protect against COVID-19. Researchers have developed various types of candidate vaccines with the release of the genetic sequence of the SARS-CoV-2 virus in January. These include inactivated viral vaccines, protein subunit vaccines, mRNA vaccines, and recombinant viral vector vaccines. To date, several vaccines have been authorized for emergency use and they have been administered in countries across the globe. Meanwhile, there are also vaccine candidates in Phase III clinical trials awaiting results and approval from authorities. These candidates have shown positive results in the previous stages of the trials, whereby they could induce an immune response with minimal side effects in the participants. This review aims to discuss the different vaccine platforms and the clinical trials of the candidate vaccines.

scholarly journals Stages in COVID-19 vaccine development: The Nemesis, the Hubris and the Elpis

2020 ◽  
Vol 4 (1) ◽  
pp. 126-135
Author(s):  
Nikhra Vinod
Keyword(s):  
Clinical Trials ◽  
Viral Vectors ◽  
Vaccine Development ◽  
Risk Groups ◽  
Phase Iii ◽  
Vaccine Hesitancy ◽  
Effective Vaccine ◽  
Vaccine Candidates ◽  
Phase Iii Clinical Trials ◽  
And Control

The nemesis: SARS-CoV-2 pandemic: Leaving in its wake millions of infections, accompanied by an immense magnitude of morbidity and multitude of mortality, and an unfathomable economic toll, the COVID-19 pandemic has led to a global calamity. An effective and safe COVID-19 vaccine is urgently needed to prevent the disease, thwart the complications and avert deaths resulting from unrestrained transmission of the infection. The hubris: Vaccine development: While most of the platforms of vaccine candidates have focused on the spike (S) protein and its variants as the primary antigen of COVID-19 infection, various techniques involved include nucleic acid technologies (RNA and DNA), non-replicating viral vectors, peptides, recombinant proteins, live attenuated and inactivated viruses. There are novel vaccine technologies being developed using next-generation strategies for precision and flexibility for antigen manipulation relating to SARS-CoV-2 infection mechanisms. The elpis: Updates and prospects: There were nine different technology platforms under research and development to create an effective vaccine against COVID 19. Although there are no licensed vaccines against COVID-19 yet, there are various potential vaccine candidates under development and advanced clinical trials. Out of them, one having undergone phase III clinical trials, has become available in some countries for use among the high-risk groups following emergency use authorization. Other COVID-19 vaccines may soon follow the suit. Conclusion: Hopes and concerns: The hope of benefiting from the vaccine to the extent that it may be the only way to tide over and control the COVID-19 pandemic, is accompanied by the likely fear of adverse effects and opposition in public for COVID-19 vaccination, including the vaccine hesitancy. Further, there is concern among scientific circles that vaccine may have opposite of the desired effect by causing antibody-dependent disease enhancement.

Potential of Mirabegron and its Extended-release Formulations for the Treatment of Overactive Bladder Syndrome

2020 ◽  
Vol 21 (2) ◽  
pp. 79-88 ◽  
Author(s):  
Pankaj Mandpe ◽  
Bala Prabhakar ◽  
Pravin Shende
Keyword(s):  
Clinical Trials ◽  
Overactive Bladder ◽  
Adverse Effects ◽  
Symptomatic Relief ◽  
Phase Iii ◽  
Overactive Bladder Syndrome ◽  
Modified Release ◽  
Blurred Vision ◽  
Antimuscarinic Drugs ◽  
Tablet Dosage

Background: Overactive bladder syndrome is a broadly occurring urological disorder with a distressing impact on the quality of life. The commonly used antimuscarinic drugs show poor patient compliance because of unsatisfactory potency, tolerability and high occurrence of adverse effects such as dry mouth, blurred vision, constipation, dizziness etc. Mirabegron is the first approved β3-adrenoreceptor agonist, used as mono or in combination therapies for overactive bladder syndrome. Objective: The present review provides an insight into the mechanism, pharmacokinetics, toxicokinetics, clinical trials and the development of various conventional and modified-release dosage forms of mirabegron for the treatment of overactive bladder syndrome. Results: The clinical trials of phase II and phase III of mirabegron demonstrated symptomatic relief from the overactive bladder without disturbing the micturition cycle. To date, mirabegron showed promising results for safety, tolerability and efficacy in patients with overactive bladder syndrome. The modified-release tablet dosage form of mirabegron appear to be a proficient and suitable replacement for antimuscarinics and revealed the tremendous potential to overcome the adverse effects of conventional antimuscarinic drugs like Oxybutyline chloride ER, Detrol LA, VESIcare, etc. Conclusion: Mirabegron shows a distinct mode of action, i.e., targeting β3-adrenoreceptors and improving bladder storage without altering void contractions. The limited side effects, high safety, efficacy and tolerability of mirabegron present an adequate substitute to antimuscarinics. However, long-term analysis and clinical studies are prerequisites for assessing the safety, tolerability and efficacy profile of mirabegron.

scholarly journals SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Nikolaos C. Kyriakidis ◽  
Andrés López-Cortés ◽  
Eduardo Vásconez González ◽  
Alejandra Barreto Grimaldos ◽  
Esteban Ortiz Prado
Keyword(s):  
Neutralizing Antibodies ◽  
Large Scale ◽  
Vaccine Development ◽  
Rna Virus ◽  
Protein S ◽  
Effective Vaccine ◽  
Phase 3 ◽  
Vaccine Candidates ◽  
Advantages And Disadvantages ◽  
The World

AbstractThe new SARS-CoV-2 virus is an RNA virus that belongs to the Coronaviridae family and causes COVID-19 disease. The newly sequenced virus appears to originate in China and rapidly spread throughout the world, becoming a pandemic that, until January 5th, 2021, has caused more than 1,866,000 deaths. Hence, laboratories worldwide are developing an effective vaccine against this disease, which will be essential to reduce morbidity and mortality. Currently, there more than 64 vaccine candidates, most of them aiming to induce neutralizing antibodies against the spike protein (S). These antibodies will prevent uptake through the human ACE-2 receptor, thereby limiting viral entrance. Different vaccine platforms are being used for vaccine development, each one presenting several advantages and disadvantages. Thus far, thirteen vaccine candidates are being tested in Phase 3 clinical trials; therefore, it is closer to receiving approval or authorization for large-scale immunizations.

scholarly journals Self-Replicating RNA Viruses for RNA Therapeutics

Molecules ◽  
2018 ◽  
Vol 23 (12) ◽  
pp. 3310 ◽  
Author(s):  
Kenneth Lundstrom
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Tumor Cells ◽  
Neutralizing Antibodies ◽  
Ebola Virus ◽  
Vaccine Development ◽  
Rna Viruses ◽  
Antibody Responses ◽  
Phase Iii ◽  
Phase I Clinical Trials

Self-replicating single-stranded RNA viruses such as alphaviruses, flaviviruses, measles viruses, and rhabdoviruses provide efficient delivery and high-level expression of therapeutic genes due to their high capacity of RNA replication. This has contributed to novel approaches for therapeutic applications including vaccine development and gene therapy-based immunotherapy. Numerous studies in animal tumor models have demonstrated that self-replicating RNA viral vectors can generate antibody responses against infectious agents and tumor cells. Moreover, protection against challenges with pathogenic Ebola virus was obtained in primates immunized with alphaviruses and flaviviruses. Similarly, vaccinated animals have been demonstrated to withstand challenges with lethal doses of tumor cells. Furthermore, clinical trials have been conducted for several indications with self-amplifying RNA viruses. In this context, alphaviruses have been subjected to phase I clinical trials for a cytomegalovirus vaccine generating neutralizing antibodies in healthy volunteers, and for antigen delivery to dendritic cells providing clinically relevant antibody responses in cancer patients, respectively. Likewise, rhabdovirus particles have been subjected to phase I/II clinical trials showing good safety and immunogenicity against Ebola virus. Rhabdoviruses have generated promising results in phase III trials against Ebola virus. The purpose of this review is to summarize the achievements of using self-replicating RNA viruses for RNA therapy based on preclinical animal studies and clinical trials in humans.

From Bench Side to Bed-Travelling on a Road to Get a Safe and Effective Vaccine Against COVID-19, Day to Save the Life

2021 ◽  
Vol 15 ◽  
Author(s):  
Suman Kumar Ray ◽  
Sukhes Mukherjee
Keyword(s):  
Neutralizing Antibodies ◽  
Cytotoxic T Cells ◽  
Immunological Response ◽  
Surface Protein ◽  
Viral Proteins ◽  
Effective Vaccine ◽  
Vaccine Candidates ◽  
High Fatality Rate ◽  
Basic Goal ◽  
Epitope Discovery

: Coronavirus Disease 2019 (COVID-19) is caused by a new strain of coronavirus called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). It is the most challenging pandemic of this century. The growing COVID-19 pandemic has triggered extraordinary efforts to restrict the virus in numerous ways, owing to the emergence of SARS-CoV-2. Immunotherapy, which includes artificially stimulating the immune system to generate an immunological response, is regarded as an effective strategy for preventing and treating several infectious illnesses and malignancies. Given the pandemic's high fatality rate and quick expansion, an effective vaccination is urgently needed to keep it under control. The basic goal of all COVID-19 vaccine programs is to develop a vaccine that causes the generation of surface protein neutralizing antibodies in subjects. The epitope discovery for the SARS-CoV-2 vaccine candidates is likewise made using an immuno-informatics methodology. It can be used to find the epitopes in viral proteins important for cytotoxic T cells and B cells. A safe and effective COVID-19 vaccine that can elicit the necessary immune response is necessary to end the epidemic. The global search for a safe and effective COVID-19 vaccine is yielding results. More than a dozen vaccines have already been approved around the world, with many more in the clinical trials. Patents can cover the underlying technology used to generate a vaccine, whereas trade secrets can cover manufacturing methods and procedures.

Auriculoterapia para o tratamento da ansiedade em estudantes universitários: revisão sistemática

2021 ◽  
Author(s):  
◽  
Lara dos Santos Silva
Keyword(s):  
Clinical Trials ◽  
Systematic Reviews ◽  
Ad Hoc ◽  
Cochrane Collaboration ◽  
Risk Of Bias ◽  
Meta Analyses ◽  
Tecnología Educativa

A ansiedade está entre os transtornos mentais de maior prevalência na população mundial, sendo a segunda causa de incapacidade mental no mundo. Dentre a população suscetível à ansiedade, destacam-se os estudantes universitários, em decorrência das situações vivenciadas no âmbito acadêmico. Os tratamentos da ansiedade podem estar pautados em recursos medicamentosos e não medicamentosos. Dentre os não medicamentosos, destacam-se as Práticas Integrativas e Complementares em Saúde e, dentre estas, a auriculoterapia. O objetivo geral deste estudo foi s intetizar as evidências disponíveis na literatura científica sobre o uso da auriculoterapia no tratamento da ansiedade em estudantes universitários. Trata-se de uma revisão sistemática da literatura, realizada em 16 bases de dados, com início em 20 de janeiro e revisão até 27 de março de 2021. Todo o processo de busca e seleção dos artigos foi feito de modo independente e pareado, e, quando necessário, um terceiro pesquisador com experiência na temática auxiliava como ad hoc na resolução dos conflitos. O relato da revisão pautou-se na diretriz Preferred Reporting Items for Systematic Reviews and Meta-Analyses, e o protocolo da revisão foi cadastrado na plataforma International Prospective Register of Systematic Reviews (registro No CRD42020205968). Utilizou-se as diretrizes Standards for Reporting Interventions in Clinical Trials of Acupuncture, Cochrane Collaboration Risk of Bias Tool, e escala de JADAD para avaliação dos artigos. A amostra final foi composta por cinco artigos. A análise dos mesmos mostrou que a auriculoterapia contribuiu para tratar a ansiedade de estudantes universitários. O uso desta intervenção deve ser considerado pelas instituições formadoras para promoção da saúde mental nesta população, e pode contribuir para a melhora do desempenho acadêmico, redução das taxas de evasão, e melhora da qualidade de vida aos universitários. O estudo também possibilitou a elaboração de uma tecnologia educativa no formato de cartilha, com o objetivo de esclarecer aos estudantes universitários sobre a ansiedade como um problema de saúde relevante na população, bem como apresentar a auriculoterapia como uma possibilidade terapêutica. Pretende-se que, em momento oportuno, a mesma seja divulgada em formato eletrônico para toda a comunidade acadêmica. Palavras-chave: Auriculoterapia. Terapia auricular. Ansiedade. Estudantes.

Alternative therapies

2016 ◽  
Author(s):  
Edzard Ernst
Keyword(s):  
Clinical Trials ◽  
Alternative Medicine ◽  
Dietary Supplements ◽  
Systematic Reviews ◽  
Alternative Therapies ◽  
Herbal Remedies ◽  
Ayurvedic Medicine ◽  
Efficacy And Safety ◽  
T'ai Chi ◽  
Rheumatic Conditions

Alternative therapies are used by many patients suffering from rheumatic conditions. In this chapter, the efficacy and safety of various forms of alternative medicine will be discussed based on the evidence from clinical trials and systematic reviews. The following treatments will be considered: acupuncture, Ayurvedic medicine, chiropractic, dietary supplements, herbal remedies, homeopathy, massage, osteopathy, t’ai chi, and yoga.

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