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- Title
A phase I/II randomized, double-blinded, placebo-controlled trial of a self-amplifying Covid-19 mRNA vaccine.
- Authors
Low, Jenny G.; de Alwis, Ruklanthi; Chen, Shiwei; Kalimuddin, Shirin; Leong, Yan Shan; Mah, Tania Ken Lin; Yuen, Natalene; Tan, Hwee Cheng; Zhang, Summer L.; Sim, Jean X. Y.; Chan, Yvonne F. Z.; Syenina, Ayesa; Yee, Jia Xin; Ong, Eugenia Z.; Sekulovich, Rose; Sullivan, Brian B.; Lindert, Kelly; Sullivan, Sean M.; Chivukula, Pad; Hughes, Steven G.
- Abstract
Coronavirus disease-19 (Covid-19) pandemic have demonstrated the importantance of vaccines in disease prevention. Self-amplifying mRNA vaccines could be another option for disease prevention if demonstrated to be safe and immunogenic. Phase 1 of this randomized, double-blinded, placebo-controlled trial (N = 42) assessed the safety, tolerability, and immunogenicity in healthy young and older adults of ascending levels of one-dose ARCT-021, a self-amplifying mRNA vaccine against Covid-19. Phase 2 (N = 64) tested two-doses of ARCT-021 given 28 days apart. During phase 1, ARCT-021 was well tolerated up to one 7.5 μg dose and two 5.0 μg doses. Local solicited AEs, namely injection-site pain and tenderness were more common in ARCT-021vaccinated, while systemic solicited AEs, mainly fatigue, headache and myalgia were reported in 62.8% and 46.4% of ARCT-021 and placebo recipients, respectively. Seroconversion rate for anti-S IgG was 100% in all cohorts, except for the 1 μg one-dose in younger adults and the 7.5 μg one-dose in older adults. Anti-S IgG and neutralizing antibody titers showed a general increase with increasing dose, and overlapped with titers in Covid-19 convalescent patients. T-cell responses were also observed in response to stimulation with S-protein peptides. Taken collectively, ARCT-021 is immunogenic and has favorable safety profile for further development.
- Subjects
COVID-19 vaccines; COVID-19; OLDER people; ANTIBODY titer; IMMUNE response
- Publication
NPJ Vaccines, 2022, Vol 7, Issue 1, p1
- ISSN
2059-0105
- Publication type
Article
- DOI
10.1038/s41541-022-00590-x