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Clinical Trials of COVID-19 Therapeutics and Vaccines
Published in Debmalya Barh, Kenneth Lundstrom, COVID-19, 2022
Candan Hizel Perry, Havva Ö. Kılgöz, Şükrü Tüzmen
Sinovac has developed CoronaVac, an IV vaccine with Aluminum hydroxide (Alum) adjuvant, which has been investigated in Phase III trials. This vaccine, applied as a two-dose IM regimen, has demonstrated good safety, tolerability, and immunogenicity against SARS-CoV-2 in healthy subjects aged 18–59 years. Only mild or moderate side effects, including 9% of participants complaining about temporary injection site pain, have been reported [38]. Furthermore, another IV SARS-CoV-2 vaccine candidate BBIBP-CorV developed by Sinopharm, was evaluated in Phase I/II in healthy individuals aged 18–80 years. Interim clinical trial results of this vaccine have shown its safety and tolerability in all subjects as a two-dose regimen. The most frequent side effect reported was fever. All participants receiving the vaccine, generated humoral responses on day 42 and seroconversion was observed after the administration of two doses of 4 μg. Currently, there are several conducted or ongoing Phase III studies in different countries, including Argentina, Peru, United Arab Emirates, Jordan, and Egypt [24]. Last but not least, the whole-virion inactivated SARS-CoV-2 vaccine, BBV152, developed by Bharat Biotech in India, is in Phase III clinical evaluation. The vaccine was formulated with TLR 7/8 agonist adsorbed to Alum, which resulted in high tolerability and improved virus-specific immune response.
Therapeutic Uses and Side Effects
Published in Fazal-I-Akbar Danish, Ahmed Ehsan Rabbani, Pharmacology in 7 Days for Medical Students, 2018
Fazal-I-Akbar Danish, Ahmed Ehsan Rabbani
If given for 3–5 days, only a few and mild side effects develop. Severe side effects only develop when amoebicides are given for up to 10 days. At injection site, pain, tenderness, muscle weakness and abscess formation can occur.Cardiotoxicity in the form of arrhythmias and CCF is rare.N, V (of central origin) and D.Generalised muscle weakness associated with tenderness, stiffness, tremors and mild paresthesias.
Effect of formulation and route of administration on the distribution of 17-hydroxyprogesterone caproate in rats
Published in Xenobiotica, 2023
Imam H. Shaik, Nupur Chaphekar, Vignesh Vasudevan, Ali Alshabi, Jaime R. Bastian, Wenchen Zhao, Steve Caritis, Raman Venkataramanan
The plasma concentration vs time profile after IM administration of the oil formulation shows a low but sustained plasma concentrations over time, and the long apparent terminal half-life indicates that the rate of absorption from the injection site is the rate-limiting step after administration of the oily formulation (Shaik et al. 2016). These observations support the clinical practice of using weekly IM injections of the oily formulation. However, in addition to injection site pain, other adverse events such as injection site swelling, urticaria, pruritis, injection site pruritis, injection site nodule, nausea, and diarrhoea have been observed (O’Brien and Lewis 2016). Intravaginal administration shows a rapid and substantial increase in uterus concentrations of 17-OHPC up to 4 h; the levels decreased over time and were undetectable at 24 h post- dose. Vaginal administration shows high concentrations in the uterus initially owing to the proximity of the dosing site. Given the lipophilicity of 17-OHPC, it can be visualized that it preferentially distributes in the adipose tissue. High concentrations of 17-OHPC were detected in the uterus and surrounding adipose tissue and low/no systemic levels were observed at corresponding times. Hence, it is logical to develop an intravaginal formulation.
Current evidence on the use of the adalimumab biosimilar SB5 (ImraldiTM): a multidisciplinary perspective
Published in Expert Opinion on Biological Therapy, 2022
Javier P. Gisbert, Karl Gaffney, David Young, Hans C. Ebbers, Giampiero Girolomoni
Based on current evidence, we can conclude that the biosimilar SB5 was approved on the basis of a robust data package [9]. Since its approval, a substantial body of real-world evidence has been generated providing additional assurance that SB5 is as effective and safe in dermatological, gastroenterological, and rheumatic immune-mediated inflammatory diseases as the reference product. Differences in terms of persistence across studies may be partly due to the perception of increased injection site pain [29,42] or potential nocebo effects [33]. Understanding and minimizing injection-site pain following sc injection of adalimumab biologics such as SB5 is important to optimize the injection experience [57]. All biologics, including biosimilars, may differ in terms of product factors on top of other triggers of the multi-factorial pathogenesis of injection site pain. These may be specific to the formulation such as excipients (including buffers), pH, differences in volume or device used (and needle size). There are data that the citrate buffer used for SB5, compared to other buffers such as saline or histidine, may be associated with increased injection site pain, which may be augmented by nocebo effects [57]. Furthermore, patient characteristics such as gender, age, and low body weight can also lead to increased susceptibility to experiencing injection site pain [57]. This reinforces the idea that a close communication between physician and patient when initiating or switching to a biosimilar is key to the successful adoption [19,58].
CpG-Adjuvanted Hepatitis B Vaccine (HEPLISAV-B®) Update
Published in Expert Review of Vaccines, 2021
The authors, Hyer R. et al. (2018), compared the safety of HEPLISAV-B with Engerix-B in three randomized, observer-blinded, active-controlled, multicenter phase 3 pivotal trials (HBV-10, HBV-16, and HBV-23) in adults[37]. The overall adverse effects, including post-injection reactions (55.1 vs. 57.1%), adverse events (55.3% vs. 58.1%), medically attended adverse events (46.0% vs. 46.2%), and new-onset immune-mediated adverse events (0.17% vs. 0.13%) were balanced between vaccine groups. The most common adverse effects are injection site pain, injection site redness, headache, fatigue, malaise, and injection site swelling. As a way of looking for autoimmune disease, the following autoantibodies were looked at: anti-nuclear antibodies, anti-double-stranded DNA antibodies, anti-neutrophil cytoplasmic antibodies, and antiphospholipid antibodies were balanced in both groups. A transient increase in anti-beta2 glycoprotein 1 IgM was observed in the HBsAg-1018 group but was not associated with a thrombotic event. Serious adverse events (4.8% vs. 4.8%) and deaths (0.28% vs. 0.21%) were generally balanced between groups.