Human Antibodies - Volume 32, issue 2

Authors: Storz, Ulrich

Article Type: Review Article

Abstract: BACKGROUND: Patent protection of therapeutic antibodies and T cell receptors is an important tool to enable the path to the market. In view of the substantial spendings for R&D and regulatory approval, sponsors expect exclusivity for their drug for a given period of time. Different categories exist to protect therapeutic antibodies and T cell receptors. One of these categories are epitope-based patent claims, with regard to which in the different jurisdictions, different patentability standards exist, which, furthermore, are constantly changed by courts and lawmakers. OBJECTIVE: This article tries to explain the patentability issues related to epitope-based …patent claims. METHODS: For this purpose, an overview is given on the respective legal provisions and court decisions. RESULTS: The study reveals that the respective patentability standards are constantly changed by courts and lawmakers. CONCLUSIONS: Companies developing therapeutic antibodies or T cell receptors need to consider these developments in their strategic planning. Show more

Keywords: Antibodies, T cell receptors, patent, epitope

DOI: 10.3233/HAB-240006

Citation: Human Antibodies, vol. 32, no. 2, pp. 35-49, 2024

Authors: Ahmed, Hiba Sh. | Ahmed, Hind Sh. | Abud, Haylim N.

Article Type: Review Article

Abstract: BACKGROUND: The number of coronavirus disease-19 (COVID-19) positive patients and fatalities keeps rising. It is important to recognize risk factors for severe outcomes. Evidence linking vitamin D deficiency and the severity of COVID-19 is tangential but substantial – relating to race, obesity, and institutionalization. OBJECTIVE: This study aims to examine the function of vitamin D and nutritional defense against infections such as COVID-19, which is the goal of this research. METHODS: This study includes observational cohort, cross-sectional, and case-control studies that estimated variances in serum levels of vitamin D among patients with mild or …severe forms of COVID-19, and in patients who died or were discharged from hospitals. Studies that assessed the risk of developing severe disorder or death in patients with vitamin D deficiency, defined as levels of vitamin D < 20 ng/mL, were also encompassed. RESULTS: In a retrospective study on 464,383 individuals, results showed that individuals who had the highest risks for severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection, and for COVID-19 severity when infected, had vitamin D levels < 30 nmol/L; Odds Ratio (OR) were 1.246 [95% Confidence Interval (CI): 1.210–1.304] and 1.513 [95%CI: 1.230–1.861], respectively. Additionally, in a retrospective observational study of 191,779 individuals in the USA. The SARS-CoV-2 positivity rate was greater in the 39,190 subjects with vitamin D < 20 ng/mL [12.5%, 95% C.I. 12.2–12.8%] than in the 27,870 subjects with sufficient serum vitamin D levels [8.1%, 95% C.I. 7.8–8.4%] and in the 12,321 subjects with serum vitamin D ⩾ 55 ng/mL [5.9%, 95% C.I. 5.5–6.4%]. CONCLUSION: People hospitalized for COVID-19 should be checked for vitamin D status and supplemented, and high-dose-in testing should be considered in the recovery trial. More importantly, screening for malnutrition and the administration of the best nutritional supplements are essential for the immune system of the human body to function as it should be. Thus, nutritional supplementation is crucial for people with risk factors as well as older adults with compromised immune systems. Show more

Keywords: Acute respiratory distress syndrome, coronavirus diseases, respiratory tract infection, mitochondrial dysfunction, antioxidants, Vitamin D

DOI: 10.3233/HAB-240009

Citation: Human Antibodies, vol. 32, no. 2, pp. 51-60, 2024

Authors: Jasim, Mervet B. | Al-Obaidi, Asmaa B. | Abdulrasul, Enas Adnan | Ghazi, Haider Faisal

Article Type: Research Article

Abstract: The antibody that crosses transplacentally from mother to fetus is very important origin of protective passive immunity against infection neonatal with enterovirus. Important varieties of coxsackievirus B3 (CVB3) are responsible for infections in newborns. The purpose from this study is to investigate in the prevalence of Coxsackie B virus in a sample of Iraqi women with miscarriage and potential role of miscarriage risk. METHODS: Between November 2022 and June 2023, we included 91 parturient women (gestational age: 4–20 weeks) who were between the ages of 15 and 40. Every participant completed a questionnaire, and blood was drawn to assess maternal …antibodies against CVB3. RESULTS: The blood seropositive rates were 46 out 91(50.54%), 2 out 46 were IgM positive (4.34%), (8–12 weeks) 23 from 46 (50%) (p -value 0.0294) gestational age more frequent among aborted women that positive for anti-coxsackie B antibody, The 25–35 age group was significantly overrepresented (51/91, 56%) compared to other age groups. CONCLUSION: This investigation posits Coxsackie B virus (CBV) as a possible etiology for miscarriage in the Iraqi female population. Further studies employing larger cohorts and robust methodologies, beyond the current detection technique, are warranted to corroborate these observations and elucidate the potential mechanisms by which CBV might induce miscarriage. Show more

Keywords: Coxsackievirus B, non-polio enterovirus, maternal IgM, missed abortion

DOI: 10.3233/HAB-240005

Citation: Human Antibodies, vol. 32, no. 2, pp. 61-65, 2024

Authors: Luaibi, Hawraa Allawi | Mohammed, Bushra Jasim

Article Type: Research Article

Abstract: BACKGROUND: Tumor necrosis factor-α (TNFα ) is a crucial physiologic regulator of immune responses, and several disorders have been associated with its dysregulation. OBJECTIVE: This study aimed to understand TNFα gene expression in adult patients with liver and pancreas disorders and examine the impact of TNFα -238 genotypes on this population. METHODS: At the Ibn Al-Baladi Hospital in Baghdad, blood samples were collected from forty patients who were diagnosed with beta thalassemia together with pancreatic disease, forty patients who were diagnosed with thalassemia …together with liver disorder, and forty patients who were diagnosed with thalassemia without pancreas or liver disorder. For the purpose of establishing a control group, forty samples were collected from persons who were of the same age and gender and seemed to be in good health. All of these individuals were deemed to be older than 18 years old. Through the utilization of real-time polymerase chain reaction (PCR), the level of TNF-α gene expression was investigated and assessed. The T-ARMS-PCR method was performed for detection and genotyping of TNFα -238 in thalassemia patients and healthy control samples. RESULTS: The result showed that TNF α gene expression assessment showed that group B (thalassemia patients with liver disorder) had higher folding than other groups while the lowest gene expression was in group D (as control group). Furthermore, the relationship between TNFα gene expressions folding with TNFα -238 genotypes in beta thalassemia major patients, discovered a considerable increase at GA genotype patients in TNFα gene expression level, followed by AA genotype compared to the GG genotype. Furthermore, the results of the current study showed an association between the presence of the mutant (A) allele whether heterozygous (GA) and homozygous (AA) with the TNF-α gene expression in thalassemia patients with liver and pancreatic disorders. CONCLUSION: Based on the results, it can be concluded that there is a relationship between the presence of the mutant (A) allele, whether heterozygous (GA) or homozygous (AA) of TNF-α 238, and TNF-α gene expression in liver and pancreatic diseases as well as in patients with thalassemia. Show more

Keywords: TNα 238 G/A, quantitative real time PCR, beta thalassemia major, gene expression

DOI: 10.3233/HAB-240022

Citation: Human Antibodies, vol. 32, no. 2, pp. 67-74, 2024

Authors: Hagras, Amira | Mohasseb, Dia | Taleb, Raghda | Bastawi, Rim | Elnemr, Rehab

Article Type: Research Article

Abstract: BACKGROUND: Anti-mutated citrullinated vimentin (MCV) antibodies have recently been recommended as a better arthritis diagnostic marker. OBJECTIVES: To investigate the association between anti-MCV antibodies and the clinical, functional, and radiographic characteristics of rheumatoid arthritis (RA) patients. METHODS: This case-control study was conducted on 40 RA patients and 40 healthy subjects. All patients were subjected to an assessment of disease using the 28-joint DAS (DAS28) and Clinical Disease Activity Index (CDAI), function by HAQ-DI, physical activity by International Physical Activity Questionnaire (IPAQ), fatigue by Functional Assessment of Chronic Illness Therapy (FACIT), serological tests as well as anti-MCV …Abs measurement. A plain X-ray of both hands and wrists was done. RESULTS: The anti-MCV Abs level was significantly higher in RA patients than in healthy controls (P < 0.001). The anti-MCV Abs had a significant positive correlation with DAS, CDAI, HAQ, RF, Anti-CCP, and CRP (P = 0.006, 0.013, 0.005, < 0.001, < 0.001and 0.041 respectively) and a significant negative correlation with FACIT (p = 0.007). Positive anti-MCV RA patients had significantly higher erosions, JSN, and a total sharp score. CONCLUSIONS: Anti-MCV Abs may contribute to poor physical activity and more fatigue in RA patients beyond their established role in disease activity and erosion. Show more

Keywords: Arthritis, anti-citrullinated protein antibodies, fatigue, rheumatoid, serologic tests, X-Rays

DOI: 10.3233/HAB-240007

Citation: Human Antibodies, vol. 32, no. 2, pp. 75-83, 2024