WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations

Singh, Jerome Amir; Kochhar, Sonali; Wolff, Jonathan; Atuire, Caesar; Bhan, Anant; Emanuel, Ezekiel J.; Faden, Ruth R.; Ghimire, Prakash; Greco, Dirceu Bartolomeu; Ho, Calvin; Moon, Suerie; Gooshki, Ehsan Shamsi; Touré, Aissatou; Thomé, Beatriz; Smith, Maxwell J.; Upshur, Ross

doi:10.1016/j.vaccine.2022.02.038

Cited by 15 publications

(7 citation statements)

References 31 publications

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“…These documents highlight the value of ADTs or APTs and the importance of community engagement but do not provide specific guidance for engagement practice or informed consent for these novel trial designs in PHEs. Of the 10 guidance documents reviewed, 4 gave specific guidance for informed consent ADT/APTs in PHE contexts 3 , 23 , 32 , 34 .…”

Section: Resultsmentioning

confidence: 99%

“…in West African countries) consent for ring vaccination cluster randomised trials 23 . For vaccine trials informed consent should inform participants that they can be unblinded when efficacious vaccines become available 34 . Consent processes and materials should be developed in collaboration with community stakeholders 2 , 3 , 27 , 35 .…”

Section: Resultsmentioning

confidence: 99%

“…This demonstrates respect for populations, aims at nurturing trust in research and acknowledges that the perception of social value of research can vary between local stakeholders and research stakeholders, particularly in international research collaborations 79 . The review has identified a range of approaches that reflect good practice for GPP/ engagement in alternative design trials for Ebola 34 , 45 , 46 , 50 , 52 , 80 and also for multi-site, multi-country COVID-19 trials delivered according to a master trial protocol 6 , 42 , 43 , 55 . However, we found limited description of pre-trial engagement that could meaningfully impact study design or implementation.…”

Section: Discussionmentioning

confidence: 99%

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A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies

Davies¹,

Ormel²,

Bernier³

et al. 2023

Wellcome Open Res

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Background: Public Health Emergencies (PHE) demand expeditious research responses to evaluate new or repurposed therapies and prevention strategies. Alternative Design Trials (ADTs) and Adaptive Platform Trials (APTs) have enabled efficient large-scale testing of biomedical interventions during recent PHEs. Design features of these trials may have implications for engagement and/or informed consent processes. We aimed to rapidly review evidence on engagement and informed consent for ADTs and APTs during PHE to consider what (if any) recommendations can inform practice. Method: In 2022, we searched 8 prominent databases for relevant peer reviewed publications and guidelines for ADTs/APTs in PHE contexts. Articles were selected based on pre-identified inclusion and exclusion criteria. We reviewed protocols and informed consent documents for a sample of large platform trials and consulted with key informants from ADTs/APT trial teams. Data were extracted and summarised using narrative synthesis. Results: Of the 49 articles included, 10 were guidance documents, 14 discussed engagement, 10 discussed informed consent, and 15 discussed both. Included articles addressed ADTs delivered during the West African Ebola epidemic and APTs delivered during COVID-19. PHE clinical research guidance documents highlight the value of ADTs/APTs and the importance of community engagement, but do not provide practice-specific guidance for engagement or informed consent. Engagement and consent practice for ADTs conducted during the West African Ebola epidemic have been well-documented. For COVID-19, engagement and consent practice was described for APTs primarily delivered in high income countries with well-developed health service structures. A key consideration is strong communication of the complexity of trial design in clear, accessible ways. Conclusion: We highlight key considerations for best practice in community engagement and informed consent relevant to ADTs and APTs for PHEs which may helpfully be included in future guidance. Protocol: The review protocol is published online at Prospero on 15/06/2022: registration number CRD42022334170.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies

Davies¹,

Ormel²,

Bernier³

et al. 2023

Wellcome Open Res

View full text Add to dashboard Cite

show abstract

“…Undoubtedly, since WHO declared COVID-19 as a public health emergency of international concern on January 30, 2020, which has made the most important contribution to the global fight against COVID-19: WHO rapidly scaled up its response including through its 149 country offices to support Member States prepare for and respond to the COVID-19 pandemic ( 51 ). Moreover, WHO made great efforts and contributions in many aspects such as carrying out clinical research on COVID-19 ( 49 ), developing COVID-19 vaccine and formulating international standards for antibody response of COVID-19 vaccine ( 52 , 53 ), formulating COVID-19 discharge guidelines ( 54 ) and WHO living guideline for drugs to prevent COVID-19 ( 55 ), and formulating regional and national coordination mechanisms for managing COVID-19 pandemic ( 56 ).…”

Section: Discussionmentioning

confidence: 99%

Uncovering the information immunology journals transmitted for COVID-19: A bibliometric and visualization analysis

et al. 2022

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BackgroundSince the global epidemic of the coronavirus disease 2019 (COVID-19), a large number of immunological studies related to COVID-19 have been published in various immunology journals. However, the results from these studies were discrete, and no study summarized the important immunological information about COVID-19 released by these immunology journals. This study aimed to comprehensively summarize the knowledge structure and research hotspots of COVID-19 published in major immunology journals through bibliometrics.MethodsPublications on COVID-19 in major immunology journals were obtained from the Web of Science Core Collection. CiteSpace, VOSviewer, and R-bibliometrix were comprehensively used for bibliometric and visual analysis.Results1,331 and 5,000 publications of 10 journals with high impact factors and 10 journals with the most papers were included, respectively. The USA, China, England, and Italy made the most significant contributions to these papers. University College London, National Institute of Allergy and Infectious Diseases, Harvard Medical School, University California San Diego, and University of Pennsylvania played a central role in international cooperation in the immunology research field of COVID-19. Yuen Kwok Yung was the most important author in terms of the number of publications and citations, and the H-index. CLINICAL INFECTIOUS DISEASES and FRONTIERS IN IMMUNOLOGY were the most essential immunology journals. These immunology journals mostly focused on the following topics: “Delta/Omicron variants”, “cytokine storm”, “neutralization/neutralizing antibody”, “T cell”, “BNT162b2”, “mRNA vaccine”, “vaccine effectiveness/safety”, and “long COVID”.ConclusionThis study systematically uncovered a holistic picture of the current research on COVID-19 published in major immunology journals from the perspective of bibliometrics, which will provide a reference for future research in this field.

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“…Vaccination is critical for controlling the COVID-19 pandemic. As of 30 June 2022, 66.4% of the world's population had received at least one dose of a COVID-19 vaccine, however only 17.4% of people in low-income countries had received a first dose, underlying unequal access, availability and delivery ( 120 – 122 ). Despite the reductions in COVID-19 disease severity, hospitalizations and deaths, since the introduction of multiple safe and effective COVID-19 vaccines, vaccine hesitancy and refusal remains substantial, caused in part by misinformation, lower education, mistrust in science and governments, and elusive broad public support ( 123 ).…”

Section: Introductionmentioning

confidence: 99%

FcγRIIa - dependent platelet activation identified in COVID-19 vaccine-induced immune thrombotic thrombocytopenia-, heparin-induced thrombocytopenia, streptokinase- and anisoylated plasminogen-streptokinase activator complex-induced platelet activation

Abdelouahed,

Yateem,

Fredericks

2023

Front. Cardiovasc. Med.

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Coronavirus disease 2019 (COVID-19), which was caused by the coronavirus - severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was globally responsible for remarkable morbidity and mortality. Several highly effective vaccines for COVID-19 were developed and disseminated worldwide within an unprecedented timescale. Rare but dangerous clotting and thrombocytopenia events, and subsequent coagulation abnormalities, have been reported after massive vaccination against SARS-CoV-2. Soon after their global rollout, reports of a morbid clinical syndrome following vaccination with adenovirus-DNA-based vaccines appeared. In the spring of 2021, reports of a novel, rare and morbid clinical syndrome, with clinically devastating and fatal complication after vaccination with adenovirus-based coronavirus vaccines (Janssen/Johnson & Johnson and Astra-Zeneca vaccines) led to a brief suspension of their use by several countries. Those complications were associated with unusual cerebral and splanchnic venous thrombosis, and circulating autoantibodies directed against anti-platelet factor 4 (PF4), a protein secreted from platelets, leading to the designation: Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT). The reported VITT incidence remains very low and does not affect the overall benefit of immunization, however, if left untreated, VITT can be debilitating or even fatal. VITT resembled specific adverse drugs' reactions that also involved the production of autoantibodies and subsequent abnormal platelet activation through platelet FcγRIIa. These unusual but well-documented drug reactions were heparin-induced thrombocytopenia (HIT), streptokinase- (SK), and anisoylated plasminogen-streptokinase activator complex- (APSAC) associated with platelet-activating antibodies. There was considerable overlapping of clinical features between VITT, COVID-19 and these adverse drugs' reactions. We review the phenomenon of VITT against the backdrop of shared and common mechanisms that underlie HIT-, SK-, and APSAC-platelet FcγRIIa-dependent platelet activation. An understanding of VITT's pathogenesis may be achieved by comparing and contrasting VITT-, HIT-, SK- and APSAC-induced platelet activation mechanisms, their respective physiopathology and similarities. Discussing these conditions in parallel provides insight into complex immunological disorders and diseases associated with abnormal hemostasis and thrombosis in particular.

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WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations

Cited by 15 publications

References 31 publications

A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies

A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies

Uncovering the information immunology journals transmitted for COVID-19: A bibliometric and visualization analysis

FcγRIIa - dependent platelet activation identified in COVID-19 vaccine-induced immune thrombotic thrombocytopenia-, heparin-induced thrombocytopenia, streptokinase- and anisoylated plasminogen-streptokinase activator complex-induced platelet activation

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