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An open-label phase 1 clinical trial aimed to investigate the safety and immune responses following a single intramuscular injection of the FINLAY-FR-1A vaccine in people (aged 22-57 years) having documented pre-existing coronavirus natural immunity.
In COVID-19 convalescents, a single
intramuscular dose of FINLAY-FR-1A vaccine against coronavirus was an effective
booster of the pre-existing natural immunity, with a very good safety profile.
An open-label phase 1 clinical
trial aimed to investigate the safety and immune responses following a single
intramuscular injection of the FINLAY-FR-1A vaccine in people (aged 22-57
years) having documented pre-existing coronavirus natural immunity.
This monocentric study recruited 30 SARS-CoV-2 convalescents and segregated them into 3 arms: Convalescents of mild coronavirus disease (N=11), asymptomatic convalescents (N=10), both with polymerase chain reaction (PCR)-positive at the time of diagnosis; and people having subclinical infection identified by viral-specific IgG (N=9). A single dose of FINLAY-FR-1A vaccine (50 µg of recombinant dimeric receptor-binding domain [RBD]) was given.
Reactogenicity and safety,
evaluated over twenty-eight days after vaccination were the major endpoints.
Vaccine immunogenicity was the secondary endpoint. Using enzyme-linked
immunosorbent assay and live-virus neutralization test, the humoral response
was determined at baseline and post-vaccination. The effector T cellular
response was also examined.
No severe noxious events were noted. Minor
side effects were noted, the most common, redness: 2 (6·7%) and local pain: 3
(10%). The FINLAY-FR-1A vaccine induced a >21 fold rise in IgG anti-RBD
antibodies twenty-eight days following vaccination. Compared to the COVID-19
convalescent panel, the median of inhibitory antibody titres (94%) was reported
to be 3 times higher. In 24 (80%) of people, the virus neutralization titres
greater than 1:160 was noted. A rise in RBD-specific T cells producing
interferon-gamma and tumor necrosis factor-alpha was also witnessed.
Immunization with the FINLAY-FR-1A
vaccine elicited high humoral and cellular responses, thus implying a
protective immunity against SARS-CoV-2. This must be confirmed in larger phase
II trials.
The Lancet Regional Health
A single dose of SARS-CoV-2 FINLAY-FR-1A vaccine enhances neutralization response in COVID-19 convalescents, with a very good safety profile: An open-label phase 1 clinical trial
Arturo Chang-Monteagudo et al.
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