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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Durability of protection and immunogenicity of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine over 6 months
Journal of Clinical Investigation, Volume 132, No. 18, Article e160565, Year 2022
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Description
BACKGROUND. We report updated safety, efficacy, and immunogenicity of AZD1222 (ChAdOx1 nCoV-19) from an ongoing phase 3 trial. METHODS. Adults at increased risk of SARS-CoV-2 infection were randomized (2:1), stratified by age, to receive 2 doses of AZD1222 or placebo. The primary efficacy end point was confirmed SARS-CoV-2 reverse-transcriptase PCR-positive (RT-PCR- positive) symptomatic COVID-19 at 15 or more days after a second dose in baseline SARS-CoV-2-seronegative participants. The 21,634 and 10,816 participants were randomized to AZD1222 and placebo, respectively. FINDINGS. Data cutoff for this analysis was July 30, 2021; median follow-up from second dose was 78 and 71 days for the doubleblind period (censoring at unblinding or nonstudy COVID-19 vaccination) and 201 and 82 days for the period to nonstudy COVID-19 vaccination (regardless of unblinding) in the AZD1222 and placebo groups, respectively. For the primary efficacy end point in the double-blind period (141 and 184 events; incidence rates: 39.2 and 118.8 per 1,000 person years), vaccine efficacy was 67.0% (P < 0.001). In the period to nonstudy COVID-19 vaccination, incidence of events remained consistently low and stable through 6 months in the AZD1222 group; for the primary efficacy end point (328 and 219 events; incidence rates: 36.4, 108.4) and severe/ critical disease (5 and 13 events; incidence rates: 0.6, 6.4), respective vaccine efficacy estimates were 65.1% and 92.1%. AZD1222 elicited humoral immune responses over time, with waning at day 180. No emergent safety issues were seen. CONCLUSION. AZD1222 is safe and well tolerated, demonstrating durable protection and immunogenicity with median followup (AZD1222 group) of 6 months. © 2022, Sobieszczyk et al.
Authors & Co-Authors
Sobieszczyk, Magdalena E.
United States, New York
Columbia University Irving Medical Center
Falsey, Ann Regina
United States, Rochester
University of Rochester
Robb, Merlin Lee
United States, Silver Spring
Walter Reed Army Institute of Research
Frenck, Robert W.
United States, Cincinnati
Cincinnati Children's Hospital Medical Center
van Tieu, Hong
United States, New York
Columbia University Irving Medical Center
United States, New York
New York Blood Center
Mayer, Kenneth H.
United States, Boston
Fenway Community Health Center
Corey, Lawrence
United States, Seattle
University of Washington
United States, Seattle
Fred Hutchinson Cancer Center
Neuzil, Kathleen Maletic
United States, Baltimore
University of Maryland, Baltimore Umb
Tong, Tina
United States, Bethesda
National Institutes of Health Nih
Isaacs, Margaret Brewinski
United States, Bethesda
National Institutes of Health Nih
Janes, Holly E.
United States, Seattle
Fred Hutchinson Cancer Center
Kelly, Elizabeth J.
United Kingdom, Cambridge
Astrazeneca
Takas, Therese
United Kingdom, Cambridge
Astrazeneca
White, Thomas
United Kingdom, Cambridge
Astrazeneca
Villafana, Tonya L.
United Kingdom, Cambridge
Astrazeneca
Hirsch, Ian
United Kingdom, Cambridge
Astrazeneca
Statistics
Citations: 18
Authors: 16
Affiliations: 11
Identifiers
Doi:
10.1172/JCI160565
ISSN:
00219738
Research Areas
Covid
Disability
Study Design
Cohort Study