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Med (New York, N.Y.) Dec 2020Antibody-based therapy for infectious diseases predates modern antibiotics and, in the absence of other therapeutic options, was deployed early in the SARS-CoV-2... (Review)
Review
Antibody-based therapy for infectious diseases predates modern antibiotics and, in the absence of other therapeutic options, was deployed early in the SARS-CoV-2 pandemic through COVID-19 convalescent plasma (CCP) administration. Although most studies have demonstrated signals of efficacy for CCP, definitive assessment has proved difficult under pandemic conditions, with rapid changes in disease incidence and the knowledge base complicating the design and implementation of randomized controlled trials. Nevertheless, evidence from a variety of studies demonstrates that CCP is as safe as ordinary plasma and strongly suggests that it can reduce mortality if given early and with sufficient antibody content.
Topics: COVID-19; Humans; Immunization, Passive; Pandemics; SARS-CoV-2; COVID-19 Serotherapy
PubMed: 33363284
DOI: 10.1016/j.medj.2020.11.002 -
Indian Journal of Medical Microbiology 2020The world is challenged with the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pandemic. Although preventive measures such as social distancing, personal... (Review)
Review
The world is challenged with the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pandemic. Although preventive measures such as social distancing, personal protective equipment and isolation would decrease the spread of the infection, a definitive treatment is still under way. Antivirals, immunisation, convalescent plasma (CP) and many more modalities are under trial, and there has been no definite answer to the management of COVID-19 infection. All patients so far have received the standard and symptomatic care. It is shown that the SARS-CoV 2 is a respiratory pathogen, and 80% of the infected patients would recover from the illness and it is the 20% of the infected patients require hospitalisation and even critical care. CP has been used to treat recent epidemic respiratory infections such as Middle East respiratory syndrome and severe acute respiratory syndrome (SARS) infections with promising results. The CP of a recovered individual contains antibodies which neutralise the virus and decrease the viral replication in the patient. It is a classic adaptive immunotherapy and has been applied in the prevention and treatment of many infectious diseases. CP is plasma taken from a person who has recovered from an infection, which contains neutralising antibodies against the said infection. Giving CP to susceptible individuals or infected patients is a form of passive antibody therapy and in the case of SARS-CoV-2, is expected to provide protection by viral neutralisation and antibody-dependent cytotoxicity and phagocytosis. The adaptive response is to a specific antigen-binding array of molecules that are foreign to the host. The human response to viruses uses both the innate and the adaptive arms in its attempt to rid the host of the invading pathogen. The humoral response is a component of the adaptive immune response that allows for antibodies to bind to foreign invading pathogens, marks the pathogens and their toxins for phagocytosis and recruits further phagocytic cells to the site via the activation of the complement system and eventually prevents the pathogen from infecting target cells. Studies from Wuhan from various institutions during the research on COVID-19 infections during December 2019 have also shown promising results. Till date, randomised controlled studies for the use of CP in SARS-CoV-2 infection are lacking, and many countries have invited institutions to participate in clinical trials. The Indian Council of Medical research and the Central Drugs Standard Control Organisation, Government of India, have allowed the use of CP as an investigational drug under a trial basis. Internationally, agencies such as the USFDA, American Association of Blood Banks, European Blood Safety and British Blood Transfusion Society have also come out with various guidelines for the use of CP in COVID-19 infection. This article will review the current guidelines for the use of CP and compare the various guidelines of different agencies.
Topics: Antibodies, Neutralizing; Antibodies, Viral; Antiviral Agents; Betacoronavirus; COVID-19; Coronavirus Infections; Female; Guidelines as Topic; Humans; Immunization, Passive; Immunotherapy; Male; Neutralization Tests; Pandemics; Pneumonia, Viral; SARS-CoV-2; Spike Glycoprotein, Coronavirus; COVID-19 Serotherapy
PubMed: 33154232
DOI: 10.4103/ijmm.IJMM_20_358 -
International Immunopharmacology Aug 2022In late 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged, causing a global pandemic called COVID-19. Currently, there is no definitive... (Review)
Review
In late 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged, causing a global pandemic called COVID-19. Currently, there is no definitive treatment for this emerging disease. Global efforts resulted in developing multiple platforms of COVID-19 vaccines, but their efficacy in humans should be wholly investigated in the long-term clinical and epidemiological follow-ups. Despite the international efforts, COVID-19 vaccination accompanies challenges, including financial and political obstacles, serious adverse effects (AEs), the impossibility of using vaccines in certain groups of people in the community, and viral evasion due to emerging novel variants of SARS-CoV-2 in many countries. For these reasons, passive immunotherapy has been considered a complementary remedy and a promising way to manage COVID-19. These approaches arebased on reduced inflammation due to inhibiting cytokine storm phenomena, immunomodulation,preventing acute respiratory distress syndrome (ARDS), viral neutralization, anddecreased viral load. This article highlights passive immunotherapy and immunomodulation approaches in managing and treating COVID-19 patients and discusses relevant clinical trials (CTs).
Topics: COVID-19; COVID-19 Vaccines; Humans; Immunization, Passive; Pandemics; SARS-CoV-2
PubMed: 35483235
DOI: 10.1016/j.intimp.2022.108786 -
The Indian Journal of Medical ResearchConvalescent plasma (CP) therapy is one of the promising therapies being tried for COVID-19 patients. This passive immunity mode involves separating preformed antibodies... (Review)
Review
Convalescent plasma (CP) therapy is one of the promising therapies being tried for COVID-19 patients. This passive immunity mode involves separating preformed antibodies against SARS-CoV-2 from a recently recovered COVID-19 patient and infusing it into a patient with active disease or an exposed individual for prophylaxis. Its advantages include ease of production, rapid deployment, specificity against the target infectious agent, and scalability. In the current pandemic, it has been used on a large scale across the globe and also in India. However, unequivocal proof of efficacy and effectiveness in COVID-19 is still not available. Various CP therapy parameters such as donor selection, antibody quantification, timing of use, and dosing need to be considered before its use. The current review attempts to summarize the available evidence and provide recommendations for setting up CP protocols in clinical and research settings.
Topics: Antibodies, Neutralizing; Antibodies, Viral; COVID-19; Humans; Immunization, Passive; India; COVID-19 Serotherapy
PubMed: 33818467
DOI: 10.4103/ijmr.IJMR_3092_20 -
Journal of Postgraduate Medicine 2021
Topics: COVID-19; Cytomegalovirus; Cytomegalovirus Infections; Humans; Immunization, Passive; Immunosuppression Therapy; Leukopenia; SARS-CoV-2; COVID-19 Serotherapy
PubMed: 33942769
DOI: 10.4103/jpgm.JPGM_55_21 -
Frontiers in Immunology 2020Passive immunization constitutes an emerging field of interest in aquaculture, particularly with the restrictions for antibiotic use. is a myxozoan intestinal parasite...
Passive immunization constitutes an emerging field of interest in aquaculture, particularly with the restrictions for antibiotic use. is a myxozoan intestinal parasite that invades the paracellular space of the intestinal epithelium, producing a slow-progressing disease, leading to anorexia, cachexia and mortalities. We have previously demonstrated that gilthead sea bream (GSB, ) that survive . infection become resistant upon re-exposure, and this resistance is directly related to the presence of high levels of specific IgM in serum. Thus, the current work was aimed to determine if passive immunization could help to prevent enteromyxosis in GSB and to study in detail the nature of these protective antibodies. Serum from a pool of resistant (SUR) or naïve (NAI) animals was intracoelomically injected 24 h prior to the . -effluent challenge and at 9 days post-challenge (dpc). Effluent challenge lasted for 23 days, and then the injected groups were allocated in separate tanks with clean water. A non-lethal parasite diagnosis was performed at 56 dpc. At the final sampling (100 dpc), blood, serum and tissues were collected for histology, molecular diagnosis and the detection of circulating antibodies. In parallel, we performed an immunoglobulin repertoire analysis of the fish generating SUR and NAI sera. The results showed that, fish injected with parasite-specific antibodies (spAbs) became infected with the parasite, but showed lower disease signs and intensity of infection than the other groups, indicating a later establishment of the parasite. Repertoire analysis revealed that induced a polyclonal expansion of diverse IgM and IgT subsets that could be in part an evasion strategy of the parasite. Nonetheless, GSB was able to produce sufficient levels of parasite-spAbs to avoid re-infection of surviving animals and confer certain degree of protection upon passive transfer of antibodies. These results highlight the crucial role of spAb responses against and set the basis for the development of effective treatment or prophylactic methods for aquaculture.
Topics: Animals; Aquaculture; Fish Proteins; Fisheries; Host-Parasite Interactions; Immunization, Passive; Immunoglobulin M; Immunoglobulins; Myxozoa; Parasitic Diseases, Animal; Sea Bream
PubMed: 33013935
DOI: 10.3389/fimmu.2020.581361 -
Expert Opinion on Investigational Drugs Jul 2020Advances in the understanding of the mechanisms that lead to Lewy body pathology in Parkinson's disease (PD) have yielded rationales for tackling neurodegeneration... (Review)
Review
INTRODUCTION
Advances in the understanding of the mechanisms that lead to Lewy body pathology in Parkinson's disease (PD) have yielded rationales for tackling neurodegeneration associated with α-Synuclein (α-Syn) misfolding, aggregation, and/or its related spreading. Immunization therapies targeting distinct α-Syn epitopes (conformational and linear) that aim to limit extracellular spread in the brain are now in development. Completed and ongoing studies have enrolled early PD patients without considering individual clinical differences and assume a common pathogenetic mechanism of the disease. Such approaches have led to disappointing results; this is most likely attributed to trial methodology and inadequate patient selection rather than underlying target biology.
AREAS COVERED
This review presents the status of immunotherapies that target α-Syn epitopes in PD. Mechanisms associated with neurodegeneration are examined along with the limitations of current antibody research strategies and ongoing clinical trials. Patient stratification based on disease progression is discussed and the article culminates with author suggestions on how to progress future clinical trials.
EXPERT OPINION
The efficacy of passive and active immunotherapies is inadequately evaluated in ongoing clinical trials where participating patients have various progression rates, genetic backgrounds, and clinical phenotypes. Future disease-modifying studies can overcome these limitations by enrolling patients based on progression pathways and genotypic contribution to disease manifestations.
Topics: Animals; Disease Progression; Humans; Immunization, Passive; Immunotherapy, Active; Parkinson Disease; Patient Selection; alpha-Synuclein
PubMed: 32419521
DOI: 10.1080/13543784.2020.1771693 -
Hematology. American Society of... Dec 2021Passive immune therapy consists of several different therapies, convalescent plasma, hyperimmune globulin, and severe acute respiratory syndrome coronavirus 2... (Review)
Review
Passive immune therapy consists of several different therapies, convalescent plasma, hyperimmune globulin, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing monoclonal antibodies. Although these treatments were not part of any pandemic planning prior to coronavirus disease 2019 (COVID-19), due to the absence of high-quality evidence demonstrating benefit in other severe respiratory infections, a large amount of research has now been performed to demonstrate their benefit or lack of benefit in different patient groups. This review summarizes the evidence up to July 2021 on their use and also when they should not be used or when additional data are required. Vaccination against SARS-CoV-2 is the most important method of preventing severe and fatal COVID-19 in people who have an intact immune system. Passive immune therapy should only be considered for patients at high risk of severe or fatal COVID-19. The only therapy that has received full regulatory approval is the casirivimab/imdevimab monoclonal cocktail; all other treatments are being used under emergency use authorizations. In Japan, it has been licensed to treat patients with mild to moderate COVID-19, and in the United Kingdom, it has also been licensed to prevent infection.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antibodies, Neutralizing; Antiviral Agents; COVID-19; Drug Combinations; Humans; Immunization, Passive; Male; SARS-CoV-2; COVID-19 Serotherapy
PubMed: 34889410
DOI: 10.1182/hematology.2021000299 -
Postgraduate Medicine Mar 2022The emergency state caused by COVID-19 saw the use of immunomodulators despite the absence of robust research. To date, the results of relatively few randomized... (Review)
Review
The emergency state caused by COVID-19 saw the use of immunomodulators despite the absence of robust research. To date, the results of relatively few randomized controlled trials have been published, and methodological approaches are riddled with bias and heterogeneity. Anti-SARS-CoV-2 antibodies, convalescent plasma and the JAK inhibitor baricitinib have gained Emergency Use Authorizations and tentative recommendations for their use in clinical practice alone or in combination with other therapies. Anti-SARS-CoV-2 antibodies are predominating the management of non-hospitalized patients, while the inpatient setting is seeing the use of convalescent plasma, baricitinib, tofacitinib, tocilizumab, sarilumab, and corticosteroids, as applicable. Available clinical data also suggest the potential clinical benefit of the early administration of blood-derived products (e.g. convalescent plasma, non-SARS-CoV-2-specific immunoglobins) and the blockade of factors implicated in the hyperinflammatory state of severe COVID-19 (Interleukin 1 and 6; Janus Kinase). Immune therapies seem to have a protective effect and using immunomodulators alone or in combination with viral replication inhibitors and other treatment modalities might prevent progression into severe COVID-19 disease, cytokine storm and death. Future trials should address existing gaps and reshape the landscape of COVID-19 management.
Topics: COVID-19; Humans; Immunization, Passive; Immunologic Factors; Pandemics; SARS-CoV-2; COVID-19 Serotherapy
PubMed: 35086413
DOI: 10.1080/00325481.2022.2033563 -
The New England Journal of Medicine Dec 2020
Topics: COVID-19; Drug Approval; Humans; Immunization, Passive; Trust; United States; United States Food and Drug Administration; COVID-19 Serotherapy; COVID-19 Drug Treatment
PubMed: 32997901
DOI: 10.1056/NEJMe2030687