@article{Dal-Re2021-mr,

title = {Ongoing and future COVID-19 vaccine clinical trials: challenges  and opportunities},

author = {Rafael Dal-R\'{e} and Linda-Gail Bekker and Christian Gluud and S\oren Holm and Vivekanand Jha and Gregory A Poland and Frits R Rosendaal and Brigitte Schwarzer-Daum and Esperanc ca Sevene and Halidou Tinto and Teck Chuan Voo and Nadarajah Sreeharan},

doi = {10.1016/S1473-3099(21)00263-2},

issn = {1474-4457 1473-3099},

year  = {2021},

date = {2021-11-01},

urldate = {2021-11-01},

journal = {Lancet Infect. Dis.},

volume = {21},

number = {11},

pages = {e342--e347},

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.},

note = {Copyright © 2021 Elsevier Ltd. All rights reserved.

PMID: 34019801 

PMCID: PMC8131060},

keywords = {Clinical Trials as Topic, COVID-19 Vaccines/administration \& dosage/immunology, COVID-19/epidemiology/immunology/prevention \& control/virology, Double-Blind Method, Humans, Immunogenicity, Pandemics/prevention \& control, SARS-CoV-2/immunology, Vaccine},

pubstate = {published},

tppubtype = {article}

}