Immunogenicity and Safety of a 3-Dose Regimen of a SARS-CoV-2 Inactivated Vaccine in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial.
J Infect Dis
; 225(10): 1701-1709, 2022 05 16.
Article
in English
| MEDLINE | ID: covidwho-1704225
ABSTRACT
BACKGROUND:
Control of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic needs effective vaccines.METHODS:
In a phase 2 randomized, double-blind, placebo-controlled trial, 500 adults aged 18-59 years or ≥60 years were randomized in 221 ratio to receive 3 doses of 5 µg or 10 µg of a SARS-CoV-2 inactivated vaccine, or placebo separated by 28 days. Adverse events (AEs) were recorded through day 28 after each dosing. Live virus or pseudovirus neutralizing antibodies, and receptor binding domain immunoglobulin G (RBD-IgG) antibody were tested after the second and third doses.RESULTS:
Two doses of the vaccine elicited geometric mean titers (GMTs) of 102-119, 170-176, and 1449-1617 for the 3 antibodies in younger adults. Pseudovirus neutralizing and RBD-IgG GMTs were similar between older and younger adults. The third dose slightly (<1.5 fold) increased GMTs. Seroconversion percentages were 94% or more after 2 doses, which were generally similar after 3 doses. The predominant AEs were injection-site pain. All the AEs were grade 1 or 2 in intensity. No serious AE was deemed related to study vaccination.CONCLUSIONS:
Two doses of this vaccine induced robust immune response and had good safety profile. A third dose given 28 days after the second dose elicited limited boosting antibody response.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Immunogenicity, Vaccine
/
COVID-19 Vaccines
/
COVID-19
Type of study:
Experimental Studies
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Adolescent
/
Adult
/
Humans
/
Middle aged
/
Young adult
Language:
English
Journal:
J Infect Dis
Year:
2022
Document Type:
Article
Affiliation country:
Infdis
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