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Ethical and Professional Issues in Epidemiology
Published in Jyoti Mishra, Ritu Agarwal, Abdon Atangana, Mathematical Modeling and Soft Computing in Epidemiology, 2020
Manoj Dubey, Ramakant Bhardwaj, Jyoti Mishra
Several challenges arose during the testing of the malaria vaccine. As such, it was not understood how to opt out of the trial of the participants, what were the side effects of the vaccine, and what is the difference between a research study and treatment. Ethics is an important element in the research and development of HIV vaccines, as HIV vaccines have many unique ethical challenges. For example, if discriminatory behavior is adopted with participants involved in a vaccine trial, AIDS may be considered a stigma due to psychological problems. In addition, researchers also need to ensure that HIV-positive participants can be protected from the stigma of the disease and how they can be treated. And researchers have to consider that if the participant does not understand the test well, they may feel that they are safe from the virus and thus put themselves at risk. The complexities of these issues reinforce ethical analysis at the borderline of HIV vaccine research.
Virus-Like Particle-Mediated Intracellular Delivery for Nanomedicine
Published in Tuan Vo-Dinh, Nanotechnology in Biology and Medicine, 2017
Jadwiga Chroboczek, Inga Szurgot
GlaxoSmithKline scientists worked on the Mosquirix™ (or RTS,S) vaccine for almost 30 years before the vaccine was approved by European drug regulators in July 2015. It should be licensed for use in babies in sub-Saharan Africa at the risk of mosquito-borne disease. The studies were funded by the PATH Malaria Vaccine Initiative and the Bill & Melinda Gates Foundation and assessed by the World Health Organization, which has promised to provide use guidance before the end of this year. The vaccine will be unable to wipe out malaria, as the trial data in 2011 and 2012 showed a reduction of only 27% in the episodes of malaria in babies aged 6–12 weeks, and of around 46% in children aged 5–17 months. The RTS,S vaccine contains the repeat and T-cell epitope of the circumsporozoite protein (CSP) of the Plasmodium falciparum malaria parasite on a platform of the hepatitis B virus VLP formed from HBsAg, to which a chemical adjuvant was added (liposome-based AS01) to boost the immune system's response. Malaria infection is prevented thanks to the induction of humoral and cellular immunity that prevent the parasite from infecting the liver (Foquet et al., 2014; Moorthy and Okwo-Bele, 2015).
Introduction to Biotechnology Operations: Planning for Success
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
Contraindication refers to those times when the team recommends that the product simply should not be used, when it might be unsafe, for example. Basic contraindications should be considered, and here again it might be helpful to consult a physician with experience of treating the disease in the indicated patient population. Warnings and precautions, on the other hand, are more difficult to define at this very early stage of development and in the absence of any safety information on the product. However, warnings and precautions from products similar in nature, treatment indication, and target patient populations may be instructive as to what may or may not be acceptable for this product. The contraindications, warnings, and precautions often narrow the indication, and this is important information to consider in product development. For the peptide used to treat hypertension, it might be contraindicated to use the drug in patients with certain other cardiovascular diseases as known from experience in cardiovascular medicine and pharmacology of similar products. The malaria vaccine might be contraindicated when the patient was already infected with the parasite. The remedial bacterium might be contraindicated when other petrochemicals, such as gasoline or diesel fuel, were present. The drought-resistant soybean plant might not be used within a kilometer of other soybean fields. The main point is that a knowledgeable product development team confronts these issues during the process of developing a TPP and well before development begins. This facilitates early planning to resolve, if possible, each potential problem or issue.
Mathematical model for the in-host malaria dynamics subject to malaria vaccines
Published in Letters in Biomathematics, 2018
Titus Okello Orwa, Rachel Waema Mbogo, Livingstone Serwadda Luboobi
Although there is no licensed vaccine against malaria today, many experts believe that a malaria vaccine is a necessary tool for successful malaria elimination (MVFG, 2018; Ouattara & Laurens, 2014). There are three categories of malaria vaccine candidates: pre-erythrocytic vaccines (PEV), blood stage vaccines (BSV) and transmission blocking vaccines (TBV) that target the parasite at different stages of its life cycle (see Figure 1). PEV are designed to prevent malaria infections in humans by inducing antibodies that block invasion of hepatocytes by sporozoites and/or cell-mediated immune responses that target infected hepatocytes (Duffy, Sahu, Akue, Milman, & Anderson, 2012). In this respect, PEVs target malaria sporozoites thereby interrupting the life cycle of malaria parasite at an early stage (March et al., 2013). Several clinical trials (Abdulla et al., 2008; Alonso et al., 2004; Bojang et al., 2001; Polhemus et al., 2009) and (RTS, S. C. T. P., 2011) have shown the potential of RTS,S to prevent malaria infection and clinical disease in infants and young children living in sub-Saharan Africa (Birkett, 2016; Miura, 2016; RTS, S. C. T. P., 2012). PEV may also induce protection against clinical malaria at the blood stage by temporarily reducing the number of merozoites that emerge from the bursting infected liver cells (Alonso et al., 2004).