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Blood Reviews Mar 2018Immunoglobulins are used to prevent or reduce infection risk in primary immune deficiencies and in settings which exploit its anti-inflammatory and immune-modulatory... (Review)
Review
Immunoglobulins are used to prevent or reduce infection risk in primary immune deficiencies and in settings which exploit its anti-inflammatory and immune-modulatory effects. Rigorous proof of immunoglobulin efficacy in persons with lympho-proliferative neoplasms, plasma cell myeloma, and persons receiving hematopoietic cell transplants is lacking despite many clinical trials. Further, there are few consensus guidelines or algorithms for use in these conditions. Rapid development of new therapies targeting B-cell signaling and survival pathways and increased use of chimeric antigen receptor T-cell (CAR-T) therapy will likely result in more acquired deficiencies of humoral immunity and infections in persons with cancer. We review immunoglobulin formulations and discuss efficacy and potential adverse effects in the context of preventing infections and in graft-versus-host disease. We suggest an algorithm for evaluating acquired deficiencies of humoral immunity in persons with hematologic neoplasms and recommend appropriate use of immunoglobulin therapy.
Topics: Antineoplastic Agents, Immunological; Autoimmune Diseases; Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation; Humans; Immunization, Passive; Immunotherapy; Treatment Outcome
PubMed: 28958644
DOI: 10.1016/j.blre.2017.09.003 -
The New England Journal of Medicine May 2022Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain.
METHODS
In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion.
RESULTS
Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized.
CONCLUSIONS
In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).
Topics: Adult; Ambulatory Care; COVID-19; Disease Progression; Double-Blind Method; Hospitalization; Humans; Immunization, Passive; Treatment Outcome; United States; COVID-19 Serotherapy
PubMed: 35353960
DOI: 10.1056/NEJMoa2119657 -
The Lancet. Haematology May 2020
Topics: Betacoronavirus; COVID-19; Coronavirus Infections; Humans; Immunization, Passive; Pandemics; Plasma; Pneumonia, Viral; SARS-CoV-2; COVID-19 Serotherapy
PubMed: 32359447
DOI: 10.1016/S2352-3026(20)30117-4 -
Microbes and Infection May 2000Antibodies can prevent infectious diseases by providing passive immune protection. Here we review successful clinical trials of passive immunization and consider some of... (Review)
Review
Antibodies can prevent infectious diseases by providing passive immune protection. Here we review successful clinical trials of passive immunization and consider some of the unique qualities monoclonal antibodies are now beginning to offer for developing methods for passive immunization against a wide range of infectious diseases.
Topics: Antibodies, Monoclonal; Bacterial Infections; Clinical Trials as Topic; Humans; Immunization, Passive; Virus Diseases
PubMed: 10884621
DOI: 10.1016/s1286-4579(00)00355-5 -
Human Vaccines & Immunotherapeutics Feb 2013If new scientific knowledge is to be more efficiently generated and applied toward the advancement of health, human safety must be more effectively addressed in the... (Review)
Review
If new scientific knowledge is to be more efficiently generated and applied toward the advancement of health, human safety must be more effectively addressed in the conduct of research. Given the present difficulties of accurately predicting biological outcomes of novel interventions in vivo, the imperative of human safety suggests the development of novel pharmaceutical products in tandem with their prospective antidotes in anticipation of possible adverse events, to render the risks of initial clinical trials more acceptable from a regulatory standpoint. Antibody-mediated immunity provides a generally applicable mechanistic basis for developing antidotes to both biologicals and small-molecule drugs (such that antibodies may serve as antidotes to pharmaceutical agents as a class including other antibodies) and also for the control and prevention of both infectious and noninfectious diseases via passive or active immunization. Accordingly, the development of prophylactic or therapeutic passive-immunization strategies using antipeptide antibodies is a plausible prelude to the development of corresponding active-immunization strategies using peptide-based vaccines. In line with this scheme, global proliferation of antibody- and vaccine-production technologies, especially those that obviate dependence on the cold chain for storage and transport of finished products, could provide geographically distributed breakout capability against emerging and future health challenges.
Topics: Antibodies; Antidotes; Biological Products; Clinical Trials as Topic; Drug Discovery; Humans; Immunization, Passive
PubMed: 23291934
DOI: 10.4161/hv.22858 -
Avian Pathology : Journal of the W.V.P.A Oct 2022Avian pathogenic (APEC) cause extra-intestinal infections called colibacillosis, which is the dominant bacterial disease in broilers. To date, given the diversity of...
Avian pathogenic (APEC) cause extra-intestinal infections called colibacillosis, which is the dominant bacterial disease in broilers. To date, given the diversity of APEC strains and the need for an acceptable level of protection in day-old chicks, no satisfactory commercial vaccine is available. As part of a French nationwide project, we selected three representative strains among several hundred APEC that cause colibacillosis disease. We first performed experiments to develop colibacillosis models, using an inoculum of 3 × 10 CFU of each strain per chick. Two APEC strains (19-381 and 19-383-M1) were found to be highly virulent for day-old chicks, whereas the third strain (19-385-M1) induced no mortality nor morbidity.We then produced an autogenous vaccine using the (Llyod, 1982; MaCQueen, 1967) 19-381 and 19-383-M1 APEC strains and a passive immunization trial was undertaken. Specific-pathogen-free Leghorn hens were vaccinated twice 2 weeks apart, the control group receiving a saline solution. The vaccinated and control hens exhibited no clinical signs, and egg production and fertility of both groups were similar. Fertile eggs were collected for 2 weeks after the second vaccination and chicks were obtained. After challenge with each APEC (19-381 and 19-383-M1), chicks appeared to be partially protected from infection with the 19-383-M1 strain, with 40% mortality compared with 80% for the non-vaccinated chicks. No protection was found when the chicks were challenged with the 19-381 strain. Now, further work is needed to consider some aspects: severity of the pathogen challenge model, persistence of the protection, number of APEC strains in the autogenous vaccine, choice of adjuvants, and heterologous protection by the vaccine made from strain 19-383-M1. Three APEC strains were characterized and selected to develop models of colibacillosis.A bivalent autogenous vaccine was produced and a passive immunization trial was carried out.Protection of chicks was demonstrated when challenged with the 19-383-M1 APEC strain (homologous challenge).Further work is needed in particular to evaluate the protection against heterologous challenge.
Topics: Animals; Autovaccines; Chickens; Escherichia coli; Escherichia coli Infections; Escherichia coli Vaccines; Female; Immunization, Passive; Ovum; Poultry Diseases
PubMed: 35634647
DOI: 10.1080/03079457.2022.2084362 -
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 -
BioMed Research International 2014The rapidly increasing global population has bowed the attention of family planning and associated reproductive health programmes in the direction of providing a safe... (Review)
Review
The rapidly increasing global population has bowed the attention of family planning and associated reproductive health programmes in the direction of providing a safe and reliable method which can be used to limit family size. The world population is estimated to exceed a phenomenal 10 billion by the year 2050 A.D., thus presenting a real jeopardy of overpopulation with severe implications for the future. Despite the availability of contraceptive methods, there are over one million elective abortions globally each year due to unintended pregnancies, having devastating impact on reproductive health of women worldwide. This highlights the need for the development of newer and improved contraceptive methods. A novel contraceptive approach that is gaining substantial attention is "immunocontraception" targeting gamete production, gamete outcome, or gamete function. Amongst these, use of sperm antigens (gamete function) seems to be an exciting and feasible approach. However, the variability of immune response and time lag to attain titer among vaccinated individuals after active immunization has highlighted the potential relevance of preformed antibodies in this league. This review is an attempt to analyze the current status and progress of immunocontraceptive approaches with respect to their establishment as a future fertility control agent.
Topics: Animals; Contraception; Contraception, Immunologic; Humans; Immunization, Passive; Vaccines, Contraceptive
PubMed: 25110702
DOI: 10.1155/2014/868196 -
Annual Review of Neuroscience 2008Immunotherapeutic strategies to combat neurodegenerative disorders have galvanized the scientific community since the first dramatic successes in mouse models recreating... (Review)
Review
Immunotherapeutic strategies to combat neurodegenerative disorders have galvanized the scientific community since the first dramatic successes in mouse models recreating aspects of Alzheimer disease (AD) were reported. However, initial human trials of active amyloid-beta (Abeta) vaccination were halted early because of a serious safety issue: meningoencephalitis in 6% of subjects. Nonetheless, some encouraging preliminary data were obtained, and rapid progress has been made toward developing alternative, possibly safer active and passive immunotherapeutic approaches for several neurodegenerative conditions. Many of these are currently in human trials for AD. Despite these advances, our understanding of the essential mechanisms underlying the effects seen in preclinical models and human subjects is still incomplete. Antibody-induced phagocytosis of pathological protein deposits, direct antibody-mediated disruption of aggregates, neutralization of toxic soluble proteins, a shift in equilibrium toward efflux of specific proteins from the brain, cell-mediated immune responses, and other mechanisms may all play roles depending on the specific immunotherapeutic scenario.
Topics: Amyloid beta-Peptides; Animals; Antibodies; Humans; Immunity; Immunization, Passive; Immunotherapy, Active; Nerve Tissue Proteins; Neurodegenerative Diseases; Vaccination
PubMed: 18352830
DOI: 10.1146/annurev.neuro.31.060407.125529 -
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