V14 England Safety and Immunogenicity of ChAdOx1 nCoV-19 Vaccine Administered in a Prime-Boost Regimen in Young and Old Adults (COV002): A Single-blind, Randomized, Controlled, Phase 2/3 Trial Results
Covid-19 Vaccine/England/ChAdOx1 nCoV-19/for Older Adults Excellent Prognosis
Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV-002): a single-blind, randomized, controlled, phase 2/3 trial
*Update this is an evaluation of another vaccine candidate aside from the Covid Vaccine mRNA-1273 that has already been approved. The mRNA-1273 Covid Vaccine was approved as of 12/01/2020.
Follow up report on British vaccine ChAdOx1 nCoV-19, including older adults
Older adults (aged ≥70 years) are at increased risk of severe disease and death if they develop COVID-19 and are therefore a priority for immunization.
Reported the immunogenicity of a novel adenovirus-vectored vaccine, ChAdOx1 nCoV-19, in young adults, and the safety and immunogenicity of this vaccine in a wider range of participants, including adults aged 70 years and older.
Phase 2 component of a single-blind, randomized, controlled, phase 2/3 trial (COV-002), healthy adults aged 18 years and older were enrolled at two UK clinical research facilities, in an age-escalation manner, into 18–55 years, 56–69 years, and 70 years and older immunogenicity subgroups.
First, participants were recruited to a low-dose cohort, and within each age group, Participants were randomly assigned to receive either intramuscular ChAdOx1 nCoV-19 (2·2 × 1010 virus particles) or a control vaccine, menACWY. Using block randomization and stratified by age and dose group and study site. Using the following ratio categories: in the 18–55 years group, 1:1 to either two doses of ChAdOx1 nCoV-19 or 2 doses of menACWY; in the 56–69 years group, 3:1:3:1 to one dose of ChAdOx1 nCoV-19, one dose of menACWY, two doses of ChAdOx1 nCoV-19, or two doses of menACWY; and in the 70 years and older, 5:1:5:1 to one dose of ChAdOx1 nCoV-19, one dose of menACWY, two doses of ChAdOx1 nCoV-19, or two doses of menACWY. Prime-booster regimens were given 28 days apart.
Between May 30 and Aug 8, 2020, 560 participants were enrolled. The following age groups assigned:160 aged 18–55 years (100 assigned to ChAdOx1 nCoV-19, 60 assigned to menACWY), 160 aged 56–69 years (120 assigned to ChAdOx1 nCoV-19: 40 assigned to menACWY), and 240 aged 70 years and older (200 assigned to ChAdOx1 nCoV-19: 40 assigned to menACWY).
By day 14 after the second dose, 208 (>99%) of 209 vaccinated participants had neutralizing antibody responses.
ChAdOx1 nCoV-19 appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a second dose.
Findings show that the ChAdOx1 nCoV-19 vaccine is safe and well tolerated with a lower reactogenicity profile in older adults than in younger adults.
Immunogenicity was similar across age groups after a second dosage vaccination.
The ChAdOx1 nCoV-19 vaccine induced a specific antibody response to the SARS-CoV-2 spike glycoprotein and RBD at 28 days after a single dose across all age groups, including adults aged 70 years and older.
