Prioritizing Second-generation SARS-CoV-2 Vaccines Through Low-dosage Challenge Studies

Overview

Journal Int J Infect Dis

Publisher Elsevier

Specialty Infectious Diseases

Date 2021 Feb 16

PMID 33592338

Citations 6

Authors

Bastian Steuwer

Euzebiusz Jamrozik

Nir Eyal

Affiliations

Soon will be listed here.

Abstract

The design of human challenge studies balances scientific validity, efficiency and study safety. This Perspective explores some advantages and disadvantages of 'low-dosage' challenge studies, in the setting of testing second-generation vaccines against COVID-19. Compared with a conventional vaccine challenge, a low-dosage vaccine challenge would be more likely to start, and start earlier. A low-dosage challenge would also be less likely to rule out a vaccine candidate that would have potentially been effective, particularly in certain target uses. A key ethical advantage of a low-dosage challenge over a conventional challenge is that both it and its dose escalation process are safer for each participant. Low-dosage studies would require larger numbers of participants than conventional challenges, but this and other potential disadvantages are less serious than they may initially appear. Overall, low-dosage challenges should be considered for certain roles such as prioritizing between second-generation vaccines against COVID-19.

Citing Articles

Pandemic vaccine testing: Combining conventional and challenge studies.

Gerhard T, Strom B, Eyal N Pharmacoepidemiol Drug Saf. 2022; 31(6):710-715.

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Spatio-temporal characteristics of the novel coronavirus attention network and its influencing factors in China.

Guo X, Zhang J, Wu X PLoS One. 2021; 16(9):e0257291.

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Vaccine-enhanced disease: case studies and ethical implications for research and public health.

Jamrozik E, Heriot G, Bull S, Parker M Wellcome Open Res. 2021; 6:154.

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The COVID-19 Pandemic and the Need for an Integrated and Equitable Approach: An International Expert Consensus Paper.

Gerotziafas G, Catalano M, Theodorou Y, Van Dreden P, Marechal V, Spyropoulos A Thromb Haemost. 2021; 121(8):992-1007.

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Do coronavirus vaccine challenge trials have a distinctive generalisability problem?.

Eyal N, Gerhard T J Med Ethics. 2021; 48(9):586-589.

PMID: 34099541 PMC: 10013549. DOI: 10.1136/medethics-2020-107109.

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