tetano
Editor, Senior Moderator
Clin Lab Med
. 2022 Mar;42(1):111-128.
doi: 10.1016/j.cll.2021.10.008. Epub 2021 Nov 3.
Vaccine-Induced Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Response and the Path to Accelerating Development (Determining a Correlate of Protection)
Amy C Sherman[SUP] 1 [/SUP], Michaël Desjardins[SUP] 2 [/SUP], Lindsey R Baden[SUP] 3 [/SUP]
Affiliations
Abstract
As new public health challenges relating to COVID-19 emerge, such as variant strains, waning vaccine efficacy over time, and decreased vaccine efficacy for special populations (immunocompromised hosts), it is important to determine a correlate of protection (CoP) to allow accurate bridging studies for special populations and against variants of concern. Large-scale phase 3 clinical trials are inefficient to rapidly assess novel vaccine candidates for variant strains or special populations, because these trials are slow and costly. Defining a practical CoP will aid in efficiently conducting future assessments to further describe protection for individuals and on a population level for surveillance.
Keywords: SARS-CoV-2; Serologic diagnostics; Vaccines.
. 2022 Mar;42(1):111-128.
doi: 10.1016/j.cll.2021.10.008. Epub 2021 Nov 3.
Vaccine-Induced Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Response and the Path to Accelerating Development (Determining a Correlate of Protection)
Amy C Sherman[SUP] 1 [/SUP], Michaël Desjardins[SUP] 2 [/SUP], Lindsey R Baden[SUP] 3 [/SUP]
Affiliations
- PMID: 35153045
- DOI: 10.1016/j.cll.2021.10.008
Abstract
As new public health challenges relating to COVID-19 emerge, such as variant strains, waning vaccine efficacy over time, and decreased vaccine efficacy for special populations (immunocompromised hosts), it is important to determine a correlate of protection (CoP) to allow accurate bridging studies for special populations and against variants of concern. Large-scale phase 3 clinical trials are inefficient to rapidly assess novel vaccine candidates for variant strains or special populations, because these trials are slow and costly. Defining a practical CoP will aid in efficiently conducting future assessments to further describe protection for individuals and on a population level for surveillance.
Keywords: SARS-CoV-2; Serologic diagnostics; Vaccines.