Malaria elimination in Zanzibar - why has it not yet succeeded ?

Malaria Journal

Background Following a 30-year development process, RTS,S/AS01E (GSK, Belgium) is the first malaria vaccine to reach Phase IV assessments. The World Health Organization-commissioned Malaria Vaccine Implementation Programme (MVIP) is coordinating the delivery of RTS,S/AS01E through routine national immunization programmes in areas of 3 countries in sub-Saharan Africa. The first doses were given in the participating MVIP areas in Malawi on 23 April, Ghana on 30 April, and Kenya on 13 September 2019. The countries participating in the MVIP have little or no baseline incidence data on rare diseases, some of which may be associated with immunization, a deficit that could compromise the interpretation of possible adverse events reported following the introduction of a new vaccine in the paediatric population. Further, effects of vaccination on malaria transmission, existing malaria control strategies, and possible vaccine-mediated selective pressure on Plasmodium falciparum variants, coul...

Malaria Journal, 2011

Background: GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative are working in partnership to develop a malaria vaccine to protect infants and children living in malaria endemic regions of sub-Saharan Africa, which can be delivered through the Expanded Programme on Immunization. The RTS,S/AS candidate vaccine has been evaluated in multiple phase I/II studies and shown to have a favourable safety profile and to be welltolerated in both adults and children. This paper details the design of the phase III multicentre efficacy trial of the RTS,S/AS01 malaria vaccine candidate, which is pivotal for licensure and policy decision-making. Methods: The phase III trial is a randomized, controlled, multicentre, participant-and observer-blind study ongoing in 11 centres associated with different malaria transmission settings in seven countries in sub-Saharan Africa. A minimum of 6,000 children in each of two age categories (6-12 weeks, 5-17 months) have been enrolled. Children were randomized 1:1:1 to one of three study groups: (1) primary vaccination with RTS,S/AS01 and booster dose of RTS,S/AS01; (2) primary vaccination with RTS,S/AS01 and a control vaccine at time of booster; (3) primary vaccination with control vaccine and a control vaccine at time of booster. Primary vaccination comprises three doses at monthly intervals; the booster dose is administered at 18 months post-primary course. Subjects will be followed to study month 32. The co-primary objectives are the evaluation of efficacy over one year post-dose 3 against clinical malaria when primary immunization is delivered at: (1) 6-12 weeks of age, with co-administration of DTPwHepB/Hib antigens and OPV; (2) 5-17 months of age. Secondary objectives include evaluation of vaccine efficacy against severe malaria, anaemia, malaria hospitalization, fatal malaria, all-cause mortality and other serious illnesses including sepsis and pneumonia. Efficacy of the vaccine against clinical malaria under different transmission settings, the evolution of efficacy over time and the potential benefit of a booster will be evaluated. In addition, the effect of RTS,S/AS01 vaccination on growth, and the safety and immunogenicity in HIV-infected and malnourished children will be assessed. Safety of the primary course of immunization and the booster dose will be documented in both age categories. Conclusions: This pivotal phase III study of the RTS,S/AS01 candidate malaria vaccine in African children was designed and implemented by the Clinical Trials Partnership Committee. The study will provide efficacy and safety data to fulfil regulatory requirements, together with data on a broad range of endpoints that will facilitate the evaluation of the public health impact of the vaccine and will aid policy and implementation decisions.

The American Journal of Tropical Medicine and Hygiene

Fifteen years of investment in malaria control on Bioko Island, Equatorial Guinea (EG), dramatically reduced malaria-associated morbidity and mortality, but the impact has plateaued. To progress toward elimination, EG is investing in the development of a malaria vaccine. We assessed the unique public-private partnership that has had such a significant impact on malaria on Bioko Island and now added a major effort on malaria vaccine development. As part of a $79M commitment, the EG government (75%) and three American energy companies (25%) have invested since 2012 greater than $55M in the Equatoguinean Malaria Vaccine Initiative (EGMVI) to support clinical development of Sanaria ® PfSPZ vaccines. In turn, the vaccine development program is building human capital and physical capacity. The EGMVI established regulatory and ethical oversight to ensure compliance with the International Conference on Harmonization and Good Clinical Practices for the first importation of investigational product, ethical approval, and conduct of a clinical trial in Equatoguinean history. The Equatoguinean Malaria Vaccine Initiative has completed three vaccine trials in EG, two vaccine trials in Tanzania, and a malaria incidence study, and initiated preparations for a 2,100-volunter clinical trial. Personnel are training for advanced degrees abroad and have been trained in Good Clinical Practices and protocolspecific methods. A new facility has established the foundation for a national research institute. Biomedical research and development within this visionary, ambitious public-private partnership is fostering major improvements in EG. The EGMVI plans to use a Plasmodium falciparum sporozoite Vaccine alongside standard malaria control interventions to eliminate Pf malaria from Bioko, becoming a potential model for elimination campaigns elsewhere.

Malaria Journal, 2013

Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades. Despite this, there is currently no licensed malaria vaccine. Researchers, clinical trialists and vaccine developers have been working on many approached to make malaria vaccine available. African research institutions have developed and demonstrated a great capacity to undertake clinical trials in accordance to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards in the last decade; particularly in the field of malaria vaccines and anti-malarial drugs. This capacity is a result of networking among African scientists in collaboration with other partners; this has traversed both clinical trials and malaria control programmes as part of the Global Malaria Action Plan (GMAP). GMAP outlined and support global strategies toward the elimination and eradication of malaria in many areas, translating in reduction in public health burden, especially for African children. In the sub-Saharan region the capacity to undertake more clinical trials remains small in comparison to the actual need. However, sustainability of the already developed capacity is essential and crucial for the evaluation of different interventions and diagnostic tools/strategies for other diseases like TB, HIV, neglected tropical diseases and noncommunicable diseases. There is urgent need for innovative mechanisms for the sustainability and expansion of the capacity in clinical trials in sub-Saharan Africa as the catalyst for health improvement and maintained.

American Journal of Bioethics, 2024

When used clinically, psychedelics may appear unusual or even unique when compared to many more familiar or long-standing medical interventions, prompting some to suggest that the ethical issues raised may likewise be exceptional. If that is correct, then perhaps psychedelics should be treated differently from other substances used within medicine: for example, by being subjected to different ethical or evidentiary standards. Alternatively, it may be that psychedelics have more in common with various existing medical interventions than first meets the eye. We argue in favor of the latter position, drawing on parallels from earlier debates around genetic exceptionalism in bioethics. We suggest there are risks to adopting a stance of "psychedelic ethical exceptionalism," and propose that consistent ethical rules and evidentiary standards should be applied across all relevant areas of clinical medicine. Importantly, this does not preclude the possibility that changes to existing standards should be made; but if so, this should not be justified by appealing to the alleged uniqueness of psychedelics.

South Russian Journal of Social Sciences, 2021

Many businesses and organizations can operate in fast changing environments, which meets the high market demands and stakeholder needs. These successful organizations can adapt to everyday changes in the business climate, based on organizational effectiveness, performance, and good strategic planning. Organizations that have failed have done so because of a lack of a good system design in place. Organizational factors such as the changing business climate, labor trends, diminishing stakeholder interests, and lack of organizational value creation to improving current structures to meet the needs are some examples of why organizations may fail. " System is defined as a set of elements arranged in an orderly manner to accomplish an objective. System, is not a randomly arranged set. It is arranged with some logic governed by rules, regulations, principles, and policies. Such an arrangement is also influenced by the objective the system desires to achieve. Systems are created to solve problems " (Deepak, 2011, para. 1). This paper examines the contextual and cultural factors and stakeholders on systems design and management in organizations by exploring the different major stakeholder group interests that shape the design that is appropriate for a management system. A collection of component that work together to realize some objectives forms a system. In a system design, the different components are interconnected with each other and they are interdependent. For example, the human body represents a complete natural system. (Deepak, 2011, para. 6) Organizational leaders are bound by many factors that affect the economics, political, cultural, educational, social systems that can affect the overall structure and effectiveness of an organization such as an organizational culture that drives value, change, and a custom system design. Organizational leaders can create a well-designed system to drive change and best practices within their organizations which can include such elements as driving change from the bottom up, communicating with stakeholders about system needs and objectives of the desired system. An organization's culture determines how stakeholders interact with each other to form a relationship that will foster value and growth within the organization (Crossan, Fry, & Killing, 2005). A competitive organization places pressure on leaders in all departments to be proficient at leading change and more Remi Alapo, doctor of Management (DM), Organizational Management and Leadership,

Graphical abstract Abstract This study investigated the relationships between organizational citizenship behavior (OCB) dimensions conscientiousness, courtesy, sportsmanship, and civic virtue and job performance. OCB is deemed as it is able to enhance the trait of job performance. Altruism, conscientiousness, courtesy, sportsmanship, and civic virtues as dimensions of OCB have been recognized to influence job performance. This was a correlational study with a cross-sectional design. Based on random sampling, 50 out of 68 engineers from SHAANXI AUTOMOBILE GROUP CO., LTD in People's republic of China were chosen. Data were collected using a questionnaire-based survey. Descriptive statistics, Pearson Coefficient, multiple regressions were used to analyze the data. The results implied that OCB dimensions substantially relates positively with job performance. Based on the study, OCB is positively related to Job Performance. It emphasizes the benefits based on the new perspective of employees with OCBs who needs to be motivated in their work place.