tetano
Editor, Senior Moderator
Int J Infect Dis
. 2021 Feb 13;S1201-9712(21)00124-7.
doi: 10.1016/j.ijid.2021.02.038. Online ahead of print.
Prioritizing between second-generation SARS-CoV-2 vaccines through low-dosage challenge studies
Bastian Steuwer[SUP] 1 [/SUP], Euzebiusz Jamrozik[SUP] 2 [/SUP], Nir Eyal[SUP] 3 [/SUP]
Affiliations
Abstract
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 to a conventional vaccine challenge, a low-dosage vaccine challenge would be likelier to start, and start earlier. A low-dosage challenge would also be less likely to rule out a vaccine candidate which would have been potentially effective in target usage. A key ethical advantage of a low-dosage challenge over conventional challenge is that both it and its dose escalation process are safer for each participant. Low-dosage studies usually 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.
Keywords: Coronavirus; Ethics; Human Challenge Studies; Research Design; Vaccines.
. 2021 Feb 13;S1201-9712(21)00124-7.
doi: 10.1016/j.ijid.2021.02.038. Online ahead of print.
Prioritizing between second-generation SARS-CoV-2 vaccines through low-dosage challenge studies
Bastian Steuwer[SUP] 1 [/SUP], Euzebiusz Jamrozik[SUP] 2 [/SUP], Nir Eyal[SUP] 3 [/SUP]
Affiliations
- PMID: 33592338
- PMCID: PMC7881292
- DOI: 10.1016/j.ijid.2021.02.038
Abstract
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 to a conventional vaccine challenge, a low-dosage vaccine challenge would be likelier to start, and start earlier. A low-dosage challenge would also be less likely to rule out a vaccine candidate which would have been potentially effective in target usage. A key ethical advantage of a low-dosage challenge over conventional challenge is that both it and its dose escalation process are safer for each participant. Low-dosage studies usually 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.
Keywords: Coronavirus; Ethics; Human Challenge Studies; Research Design; Vaccines.