Your browser doesn't support javascript.
Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities.
Dal-Ré, Rafael; Bekker, Linda-Gail; Gluud, Christian; Holm, Søren; Jha, Vivekanand; Poland, Gregory A; Rosendaal, Frits R; Schwarzer-Daum, Brigitte; Sevene, Esperança; Tinto, Halidou; Voo, Teck Chuan; Sreeharan, Nadarajah.
  • Dal-Ré R; Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: rafael.dalre@quironsalud.es.
  • Bekker LG; The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
  • Gluud C; The Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Rigshospitalet, Copenhagen, Denmark; Institute for Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
  • Holm S; Centre for Social Ethics and Policy, Department of Law, University of Manchester, Manchester, UK.
  • Jha V; George Institute for Global Health, UNSW, New Delhi, India; Manipal Academy of Higher Education, Manipal, India.
  • Poland GA; Mayo Clinic Vaccine Research Group and Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.
  • Rosendaal FR; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, Netherlands.
  • Schwarzer-Daum B; Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
  • Sevene E; Department of Physiological Sciences, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique; Manhiça Health Research Centre, Maputo, Mozambique.
  • Tinto H; Clinical Research Unit of Nanoro, Institut de Recherche en Sciences de La Santé, Nanoro, Burkina Faso.
  • Voo TC; Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
  • Sreeharan N; Department of Medicine, University of Jaffna, Jaffna, Sri Lanka.
Lancet Infect Dis ; 21(11): e342-e347, 2021 11.
Article in English | MEDLINE | ID: covidwho-1561809
ABSTRACT
Large-scale deployment of COVID-19 vaccines will seriously affect the ongoing phases 2 and 3 randomised placebo-controlled trials assessing SARS-CoV-2 vaccine candidates. The effect will be particularly acute in high-income countries where the entire adult or older population could be vaccinated by late 2021. Regrettably, only a small proportion of the population in many low-income and middle-income countries will have access to available vaccines. Sponsors of COVID-19 vaccine candidates currently in phase 2 or initiating phase 3 trials in 2021 should consider continuing the research in countries with limited affordability and availability of COVID-19 vaccines. Several ethical principles must be implemented to ensure the equitable, non-exploitative, and respectful conduct of trials in resource-poor settings. Once sufficient knowledge on the immunogenicity response to COVID-19 vaccines is acquired, non-inferiority immunogenicity trials-comparing the immune response of a vaccine candidate to that of an authorised vaccine-would probably be the most common trial design. Until then, placebo-controlled, double-blind, crossover trials will continue to play a role in the development of new vaccine candidates. WHO or the Council for International Organizations of Medical Sciences should define an ethical framework for the requirements and benefits for trial participants and host communities in resource-poor settings that should require commitment from all vaccine candidate sponsors from high-income countries.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Clinical Trials as Topic / COVID-19 Vaccines / COVID-19 Subject: Clinical Trials as Topic / COVID-19 Vaccines / COVID-19 Type of study: Controlled clinical trial / Ethical aspects Language: English Journal: Lancet Infect Dis Year: 2021

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Clinical Trials as Topic / COVID-19 Vaccines / COVID-19 Subject: Clinical Trials as Topic / COVID-19 Vaccines / COVID-19 Type of study: Controlled clinical trial / Ethical aspects Language: English Journal: Lancet Infect Dis Year: 2021
...