scholarly journals Engagement of ethics and regulatory authorities on human infection studies: Proceedings of an engagement workshop in Zambia

2021 ◽  
Vol 6 ◽  
pp. 31
Author(s):  
Evelyn Muleba Kunda-Ng'andu ◽  
Michelo Simuyandi ◽  
Melissa Kapulu ◽  
Masuzyo Chirwa-Chobe ◽  
Hope Mwanyungwi-Chinganya ◽  
...  
Keyword(s):  
Vaccine Development ◽  
Legal Framework ◽  
Human Infection ◽  
Community Safety ◽  
Comprehensive Understanding ◽  
African Countries ◽  
Civic Leaders ◽  
Regulatory Issues ◽  
Appropriate Treatment ◽  
First Time

Human infection studies (HIS) have generally been used as a tool in the pathway for vaccine development in high income settings. Over the last decade, this model has been implemented in LMICs with the aim of accelerating development of next generation vaccines that would perform better in these settings. However, in most LMICs, the ethics and regulatory framework for the conduct of these studies are not in place. In Zambia, these studies are yet to be conducted and thus we conducted a stakeholder engagement workshop in October 2019. We engaged with bioethicists, regulatory authority officials, and scientists from within Zambia and other African countries to anticipate and address foreseeable ethical and regulatory issues when conducting HIS in Zambia for the first time. The workshop largely focused on sensitizing the stakeholders on the benefits of these studies with the following main points for consideration on the implementation of these studies in Zambia: need for in-country legal framework and guidelines; need for adequate informed consent based on comprehensive understanding of the concept of HIS and study requirements; and requirements for heightened vigilance to assure participant safety including good ethical and clinical practice with regulatory, ethical, data safety, and community oversight. Additionally, the workshop emphasized the need for rigorous health screening prior to enrolment; suitable infrastructure for containment; and personnel to provide appropriate treatment including emergency resuscitation and evacuation if indicated. Specific recommendations included compensation for burden of participation; access to care and provision for study related injury (e.g. no-fault insurance); and withdrawal and exit procedures to preserve individual and community safety. Finally, the meeting concluded that researchers should actively engage key gate keepers including civic leaders such as parliamentarians, universities, researchers, potential participants and laypersons to avoid circulation of misinformation.

scholarly journals Engagement of ethics and regulatory authorities on human infection studies: Proceedings of an engagement workshop in Zambia

2021 ◽  
Vol 6 ◽  
pp. 31
Author(s):  
Evelyn Muleba Kunda-Ng'andu ◽  
Michelo Simuyandi ◽  
Melissa Kapulu ◽  
Masuzyo Chirwa-Chobe ◽  
Hope Mwanyungwi-Chinganya ◽  
...  
Keyword(s):  
Vaccine Development ◽  
Legal Framework ◽  
Human Infection ◽  
Community Safety ◽  
Comprehensive Understanding ◽  
African Countries ◽  
Civic Leaders ◽  
Regulatory Issues ◽  
Appropriate Treatment ◽  
First Time

Human infection studies (HIS) have generally been used as a tool in the pathway for vaccine development in high income settings. Over the last decade, this model has been implemented in LMICs with the aim of accelerating development of next generation vaccines that would perform better in these settings. However, in most LMICs, the ethics and regulatory framework for the conduct of these studies are not in place. In Zambia, these studies are yet to be conducted and thus we conducted a stakeholder engagement workshop in October 2019. We engaged with bioethicists, regulatory authority, and scientists from within Zambia and other African countries to anticipate and address foreseeable ethical and regulatory issues when conducting HIS in Zambia for the first time. The workshop largely focused on sensitizing the stakeholders on the benefits of these studies with the following main points for consideration on the implementation of these studies in Zambia: need for in-country legal framework and guidelines; need for adequate informed consent based on comprehensive understanding of the concept of HIS and study requirements; and requirements for heightened vigilance to assure participant safety including good ethical and clinical practice with regulatory, ethical, data safety, and community oversight. Additionally, the workshop emphasized the need for rigorous health screening prior to enrolment; suitable infrastructure for containment; and personnel to provide appropriate treatment including emergency resuscitation and evacuation if indicated. Specific recommendations included compensation for burden of participation; access to care and provision for study related injury (e.g. no-fault insurance); and withdrawal and exit procedures to preserve individual and community safety. Finally, the meeting concluded that researchers should actively engage key gate keepers including civic leaders such as parliamentarians, universities, researchers, potential participants and laypersons to avoid circulation of misinformation.

scholarly journals A framework for Controlled Human Infection Model (CHIM) studies in Malawi: Report of a Wellcome Trust workshop on CHIM in Low Income Countries held in Blantyre, Malawi

2017 ◽  
Vol 2 ◽  
pp. 70 ◽  
Author(s):  
Stephen B Gordon ◽  
Jamie Rylance ◽  
Amy Luck ◽  
Kondwani Jambo ◽  
Daniela M Ferreira ◽  
...  
Keyword(s):  
Low Income ◽  
Vaccine Development ◽  
Clinical Laboratory ◽  
Human Infection ◽  
Low Income Countries ◽  
Infection Model ◽  
Proof Of Concept ◽  
Middle Income ◽  
Regulatory Issues ◽  
Middle Income Countries

Controlled human infection model (CHIM) studies have pivotal importance in vaccine development, being useful for proof of concept, pathogenesis, down-selection and immunogenicity studies.  To date, however, they have seldom been carried out in low and middle income countries (LMIC), which is where the greatest burden of vaccine preventable illness is found.  This workshop discussed the benefits and barriers to CHIM studies in Malawi.  Benefits include improved vaccine effectiveness and host country capacity development in clinical, laboratory and governance domains.  Barriers include acceptability, safety and regulatory issues. The report suggests a framework by which ethical, laboratory, scientific and governance issues may be addressed by investigators considering or planning CHIM in LMIC.

scholarly journals In silico characterisation of putative Plasmodium falciparum vaccine candidates in African malaria populations

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
O. Ajibola ◽  
M. F. Diop ◽  
A. Ghansah ◽  
L. Amenga-Etego ◽  
L. Golassa ◽  
...  
Keyword(s):  
Plasmodium Falciparum ◽  
Malaria Vaccine ◽  
Transmembrane Domain ◽  
Vaccine Development ◽  
Balancing Selection ◽  
Immune Recognition ◽  
African Countries ◽  
Vaccine Candidates ◽  
D Values ◽  
Tajima’S D

AbstractGenetic diversity of surface exposed and stage specific Plasmodium falciparum immunogenic proteins pose a major roadblock to developing an effective malaria vaccine with broad and long-lasting immunity. We conducted a prospective genetic analysis of candidate antigens (msp1, ama1, rh5, eba175, glurp, celtos, csp, lsa3, Pfsea, trap, conserved chrom3, hyp9, hyp10, phistb, surfin8.2, and surfin14.1) for malaria vaccine development on 2375 P. falciparum sequences from 16 African countries. We described signatures of balancing selection inferred from positive values of Tajima’s D for all antigens across all populations except for glurp. This could be as a result of immune selection on these antigens as positive Tajima’s D values mapped to regions with putative immune epitopes. A less diverse phistb antigen was characterised with a transmembrane domain, glycophosphatidyl anchors between the N and C- terminals, and surface epitopes that could be targets of immune recognition. This study demonstrates the value of population genetic and immunoinformatic analysis for identifying and characterising new putative vaccine candidates towards improving strain transcending immunity, and vaccine efficacy across all endemic populations.

scholarly journals Progress and challenges in TB vaccine development

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 199 ◽  
Author(s):  
Gerald Voss ◽  
Danilo Casimiro ◽  
Olivier Neyrolles ◽  
Ann Williams ◽  
Stefan H.E. Kaufmann ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Vaccine Development ◽  
Scientific Progress ◽  
Human Infection ◽  
Experimental Medicine ◽  
Vaccine Platform ◽  
Vaccine Candidates ◽  
Clinical Endpoints ◽  
Immune Correlates ◽  
Efficacy Trials

The Bacille Calmette Guerin (BCG) vaccine can provide decades of protection against tuberculosis (TB) disease, and although imperfect, BCG is proof that vaccine mediated protection against TB is a possibility. A new TB vaccine is, therefore, an inevitability; the question is how long will it take us to get there? We have made substantial progress in the development of vaccine platforms, in the identification of antigens and of immune correlates of risk of TB disease. We have also standardized animal models to enable head-to-head comparison and selection of candidate TB vaccines for further development.  To extend our understanding of the safety and immunogenicity of TB vaccines we have performed experimental medicine studies to explore route of administration and have begun to develop controlled human infection models. Driven by a desire to reduce the length and cost of human efficacy trials we have applied novel approaches to later stage clinical development, exploring alternative clinical endpoints to prevention of disease outcomes. Here, global leaders in TB vaccine development discuss the progress made and the challenges that remain. What emerges is that, despite scientific progress, few vaccine candidates have entered clinical trials in the last 5 years and few vaccines in clinical trials have progressed to efficacy trials. Crucially, we have undervalued the knowledge gained from our “failed” trials and fostered a culture of risk aversion that has limited new funding for clinical TB vaccine development. The unintended consequence of this abundance of caution is lack of diversity of new TB vaccine candidates and stagnation of the clinical pipeline. We have a variety of new vaccine platform technologies, mycobacterial antigens and animal and human models.  However, we will not encourage progression of vaccine candidates into clinical trials unless we evaluate and embrace risk in pursuit of vaccine development.

scholarly journals Stakeholder views on the acceptability of Human Infection Studies in Malawi

2019 ◽  
Author(s):  
Blessings M. Kapumba ◽  
Kondwani Jambo ◽  
Jamie Rylance ◽  
Markus Gmeiner ◽  
Rodrick Sambakunsi ◽  
...  
Keyword(s):  
Vaccine Development ◽  
Human Infection ◽  
Stakeholder Perceptions ◽  
Ethical Challenges ◽  
Inclusion Criteria ◽  
Government Officials ◽  
District Health ◽  
Middle Income ◽  
Rural And Urban ◽  
Ongoing Assessment

Abstract Background: Human infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMIC) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMIC. Methods: We conducted 6 deliberative focus groups and 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members and district health government officials. Findings: Stakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example balancing equity, safety and relevance in inclusion criteria. Conclusions: Our findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out. Key words: Human Infection Studies, pneumococcal, Malawi, acceptability, ethics

scholarly journals Unique clinical spectrum with distinguishing diagnostic features in Vogt-Koyanagi-Harada syndrome

2019 ◽  
Vol 12 (12) ◽  
pp. e231397
Author(s):  
Mamoona Sultan ◽  
Adeena Khan ◽  
Syed Shahid Habib ◽  
Dheyab Abdulsalam
Keyword(s):  
Nerve Conduction ◽  
Immunosuppressive Drug ◽  
Diagnostic Features ◽  
Cutaneous Manifestations ◽  
Ophthalmic Manifestations ◽  
Systemic Corticosteroids ◽  
Appropriate Treatment ◽  
Ophthalmic Imaging ◽  
First Time

A 36-year-old ulcerative colitis male patient on treatment for 7 years was referred to dermatology with resistant alopecia universalis and hypopigmented patches on limbs for 5 months. During this time he also reported to ophthalmology with acute bilateral decreased vision for 5 days. His examination revealed hyperaemic discs, multifocal retinal detachments and choroidal granulomas. Taking into account the revised diagnostic criteria, atypical course of disease in the form of early cutaneous presentation followed by ophthalmic manifestations was attributed to Vogt-Koyanagi-Harada syndrome (VKHS) which was supported by relevant investigations including ophthalmic imaging, MRI and nerve conduction studies. Subclinical nerve conduction abnormalities and white matter demyelination were also seen for the first time in a patient of VKHS. Appropriate treatment was required to prevent visual complications; therefore, systemic corticosteroids with steroid sparing immunosuppressive drug therapy showed significant improvement in vision on follow-up. Cutaneous manifestations were resilient to the entire regimen.

scholarly journals Judicial review and the future of UK development assistance: On the Application of O v Secretary of State for International Development (2014)

Legal Studies ◽  
2018 ◽  
Vol 38 (2) ◽  
pp. 320-335
Author(s):  
John Harrington ◽  
Ambreena Manji
Keyword(s):  
International Development ◽  
Judicial Review ◽  
Development Assistance ◽  
National Income ◽  
Legal Framework ◽  
Development Aid ◽  
Secretary Of State ◽  
Development Spending ◽  
Accountability Gap ◽  
First Time

AbstractIn this paper we explore a case for judicial review brought against the Secretary of State for International Development by an Ethiopian national, Mr O. The claimant alleged that the Department for International Development (DfID) had failed adequately to assess evidence of human rights violations in Ethiopia to which funds provided by DfID had contributed. Warby J ruled that the claim merited a full hearing. DfID is unaccustomed to judicial review: the O case is the first time since the 1995 Pergau Dam case that UK development aid has been reviewed by the courts. We study Warby J's judgment and its implications for accountabiity for aid decisions. We argue that both the wider context for aid and the legal framework governing development assistance have changed significantly in the 20 or so years since Pergau. In particular, we show that despite the UK's new legal commitment, made in 2015, to spend 0.7% of gross national income (GNI) on official development assistance, the existing mechanisms for scrutinising aid decisions are inadequate. We argue that there is an accountability gap in relation to the UK's now considerable development spending and explore the role of judicial review in this context.

scholarly journals Normocyte-binding protein required for human erythrocyte invasion by the zoonotic malaria parasite Plasmodium knowlesi

2016 ◽  
Vol 113 (26) ◽  
pp. 7231-7236 ◽  
Author(s):  
Robert W. Moon ◽  
Hazem Sharaf ◽  
Claire H. Hastings ◽  
Yung Shwen Ho ◽  
Mridul B. Nair ◽  
...  
Keyword(s):  
Vaccine Development ◽  
Plasmodium Knowlesi ◽  
Binding Protein ◽  
Cynomolgus Macaque ◽  
Genomic Analysis ◽  
Human Infection ◽  
Comparative Genomic ◽  
Gene Encoding ◽  
Human Rbcs

The dominant cause of malaria in Malaysia is now Plasmodium knowlesi, a zoonotic parasite of cynomolgus macaque monkeys found throughout South East Asia. Comparative genomic analysis of parasites adapted to in vitro growth in either cynomolgus or human RBCs identified a genomic deletion that includes the gene encoding normocyte-binding protein Xa (NBPXa) in parasites growing in cynomolgus RBCs but not in human RBCs. Experimental deletion of the NBPXa gene in parasites adapted to growth in human RBCs (which retain the ability to grow in cynomolgus RBCs) restricted them to cynomolgus RBCs, demonstrating that this gene is selectively required for parasite multiplication and growth in human RBCs. NBPXa-null parasites could bind to human RBCs, but invasion of these cells was severely impaired. Therefore, NBPXa is identified as a key mediator of P. knowlesi human infection and may be a target for vaccine development against this emerging pathogen.

scholarly journals Dog ownership, dog behaviour and transmission of Echinococcus spp. in the Alay Valley, southern Kyrgyzstan

Parasitology ◽  
2013 ◽  
Vol 140 (13) ◽  
pp. 1674-1684 ◽  
Author(s):  
FREYA VAN KESTEREN ◽  
ALEXANDER MASTIN ◽  
BERMET MYTYNOVA ◽  
ISKENDER ZIADINOV ◽  
BELGEES BOUFANA ◽  
...  
Keyword(s):  
Soviet Union ◽  
Rural Communities ◽  
Environmental Contamination ◽  
Human Infection ◽  
Domestic Dogs ◽  
Dog Ownership ◽  
The Soviet Union ◽  
Almost All ◽  
First Time ◽  
Echinococcus Spp

SUMMARYEchinococcosis is a re-emerging zoonotic disease in Kyrgyzstan, and the incidence of human infection has increased substantially since the collapse of the Soviet Union in 1991. Domestic dogs are hosts of Echinococcus spp. and play an important role in the transmission of these parasites. The demography, ecology and behaviour of dogs are therefore relevant in studying Echinococcus spp. transmission. Dog demographics, roles of dogs, dog movements and faecal environmental contamination were assessed in four rural communities in the Alay Valley, southern Kyrgyzstan. Arecoline purge data revealed for the first time that E. granulosus, E. canadensis and E. multilocularis were present in domestic dogs in the Alay Valley. Surveys revealed that many households had dogs and that dogs played various roles in the communities, as pets, guard dogs or sheep dogs. Almost all dogs were free to roam, and GPS data revealed that many moved outside their communities, thus being able to scavenge offal and consume rodents. Faecal environmental contamination was high, presenting a significant infection risk to the local communities.

scholarly journals Dracunculiasis (Guinea Worm Disease) and the Eradication Initiative

2002 ◽  
Vol 15 (2) ◽  
pp. 223-246 ◽  
Author(s):  
Sandy Cairncross ◽  
Ralph Muller ◽  
Nevio Zagaria
Keyword(s):  
Health Care ◽  
Human Infection ◽  
Lower Limbs ◽  
Socioeconomic Impact ◽  
Large Female ◽  
Significant Progress ◽  
African Countries ◽  
Guinea Worm ◽  
Primary Health ◽  
Control And Eradication

SUMMARY Dracunculiasis, also known as guinea worm disease, is caused by the large female of the nematode Dracunculus medinensis, which emerges painfully and slowly from the skin, usually on the lower limbs. The disease can infect animals, and sustainable animal cycles occur in North America and Central Asia but do not act as reservoirs of human infection. The disease is endemic across the Sahel belt of Africa from Mauritania to Ethiopia, having been eliminated from Asia and some African countries. It has a significant socioeconomic impact because of the temporary disability that it causes. Dracunculiasis is exclusively caught from drinking water, usually from ponds. A campaign to eradicate the disease was launched in the 1980s and has made significant progress. The strategy of the campaign is discussed, including water supply, health education, case management, and vector control. Current issues including the integration of the campaign into primary health care and the mapping of cases by using geographic information systems are also considered. Finally, some lessons for other disease control and eradication programs are outlined.

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