tetano
Editor, Senior Moderator
Clin Microbiol Infect
. 2021 Jan 6;S1198-743X(20)30792-8.
doi: 10.1016/j.cmi.2020.12.032. Online ahead of print.
Testing SARS-CoV-2 vaccine efficacy through deliberate natural viral exposure
Nir Eyal[SUP] 1 [/SUP], Marc Lipsitch[SUP] 2 [/SUP]
Affiliations
Abstract
Background: A vaccine trial with a conventional challenge design can be very fast once it starts, but it requires a long prior process, in part, to grow and standardize challenge virus in the laboratory. This detracts somewhat from its overall promise for accelerated efficacy testing of SARS-CoV-2 vaccine candidates, and from the ability of developing countries and small companies to conduct it.
Objectives: We set out to identify a challenge design that avoids this part of the long prior process.
Sources: Literature in trial design (including a proof of concept flu challenge trial by B. Killingley et al), vaccinology, medical ethics, and various aspects of COVID response.
Content: A challenge design with deliberate natural viral exposure avoids the need to grow culture. This new design is described and compared both to a conventional challenge design and to a conventional phase III field trial. In comparison, the propsed design has ethical, scientific, and feasibility strengths.
Implications: The proposed new design should be considered for future vaccine trials.
Keywords: Coronavirus; Ethics; Human challenge studies; Randomized controlled trials; Research design; Vaccines.
. 2021 Jan 6;S1198-743X(20)30792-8.
doi: 10.1016/j.cmi.2020.12.032. Online ahead of print.
Testing SARS-CoV-2 vaccine efficacy through deliberate natural viral exposure
Nir Eyal[SUP] 1 [/SUP], Marc Lipsitch[SUP] 2 [/SUP]
Affiliations
- PMID: 33421580
- DOI: 10.1016/j.cmi.2020.12.032
Abstract
Background: A vaccine trial with a conventional challenge design can be very fast once it starts, but it requires a long prior process, in part, to grow and standardize challenge virus in the laboratory. This detracts somewhat from its overall promise for accelerated efficacy testing of SARS-CoV-2 vaccine candidates, and from the ability of developing countries and small companies to conduct it.
Objectives: We set out to identify a challenge design that avoids this part of the long prior process.
Sources: Literature in trial design (including a proof of concept flu challenge trial by B. Killingley et al), vaccinology, medical ethics, and various aspects of COVID response.
Content: A challenge design with deliberate natural viral exposure avoids the need to grow culture. This new design is described and compared both to a conventional challenge design and to a conventional phase III field trial. In comparison, the propsed design has ethical, scientific, and feasibility strengths.
Implications: The proposed new design should be considered for future vaccine trials.
Keywords: Coronavirus; Ethics; Human challenge studies; Randomized controlled trials; Research design; Vaccines.