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A Phase1 Results of a Non-Stabilized Spike-Encoding mRNA Vaccine in Adults (preprint)
medrxiv; 2022.
Preprint
in English
| medRxiv | ID: ppzbmed-10.1101.2022.05.12.22274989
ABSTRACT
Background Effective COVID-19 mRNA vaccines are mainly available in high-income countries. ChulaCov19, a prefusion non-stabilized Spike protein-encoding, nucleoside-modified mRNA, lipid nanoparticle encapsulated vaccine development, aims to enhance accessibility of mRNA vaccine and future pandemic preparedness for low- to middle-income countries. Methods Seventy-two eligible volunteers, 36 aged 18-55 (adults) followed by 36 aged 56-75 (elderly) enrolled in a dose escalation study of ChulaCov19 mRNA vaccine. Two doses of vaccine were given 21 days apart at 10, 25, or 50 g/dose (12/group). Safety was the primary and immunogenicity the secondary outcome. Human convalescents' (HCS) and Pfizer/BioNTech vaccinees' sera provided comparison panels. Results All three doses of ChulaCov19 were well tolerated and elicited robust dose-dependent and age-dependent B- and T-cell responses. Transient mild/moderate injection site pain, fever, chills, fatigue, and headache were more common after the second dose. Four weeks after the second ChulaCov19 dose at 10, 25, and 50 g dose, MicroVNT-50 Geometric mean titer (GMT) against wild-type was 848, 736 and 1,140 IU/mL, respectively, versus 267 IU/mL for HCS. All dose levels elicited 100% seroconversion, with GMT ratio 4-8-fold higher than for HCS (p<0.01), and high IFN{gamma} spot-forming cells/million peripheral blood mononuclear cells. The 50 g dose induced better cross-neutralization against Alpha, Beta, Gamma, and Delta variants than lower doses. Conclusions ChulaCov19 at 50 g/dose is well tolerated and elicited higher neutralizing antibodies than HCS with strong T-cell responses. These antibodies cross neutralized four variants of concern and ChulaCov19 has therefore proceeded to phase 2 and 3 clinical trials.
Full text:
Available
Collection:
Preprints
Database:
medRxiv
Main subject:
Pain
/
Convalescence
/
Fatigue
/
Fever
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COVID-19
/
Headache
Language:
English
Year:
2022
Document Type:
Preprint
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