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BMC medicine · 2025

A booster dose of an inactivated SARS-CoV-2 vaccine targeting virus variants sustains protective humoral and cellular immunity.

СтатьяРандомизированное исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Méndez Constanza, Rodríguez-Guilarte Linmar, Palacios Pablo A, Gutierrez-Vera Cristian, Román Francisca, Moreno-Tapia Daniela, Ríos Mariana, Reyes Antonia, Cancino Felipe A, Otero Francisco F, Zurita Constanza, Rivera Daniela, Cabrera Alex, Duarte Luisa F, Urzúa Marcela, Iturriaga Carolina, Rojas Álvaro, Perez Carlos M, Redlich Andrea Schilling, Fasce Rodrigo A, Fernández Jorge, Mora Judith, Ramírez Eugenio, Domínguez Angélica, Weiskopf Daniela, Grifoni Alba, Sette Alessandro, Zeng Gang, Meng Weining, Goldbatt David, Johnson Marina, CoronaVarCL study group, González-Aramundiz José V, Álvarez-Figueroa María J, Abarca Katia, Carreño Leandro J, González Pablo A, Kalergis Alexis M, Peñaloza Hernán F, Bueno Susan M

Аннотация

BACKGROUND: The Omicron lineage of SARS-CoV-2 showed a remarkable ability to escape vaccine-induced immunity. In a Phase 2 clinical trial, we investigated whether a third booster/fifth dose of one of three inactivated SARS-CoV-2 vaccine candidates, based on the Delta and Omicron BA.1 variants, enhanced humoral and cellular immune responses against SARS-CoV-2.

METHODS: Volunteers who received either four doses of CoronaVac® (homologous group, n = 228) or two doses of CoronaVac® followed by two mRNA vaccine doses (heterologous group, n = 298) were randomly assigned to receive an Omicron BA.1-based, trivalent (ancestral, Delta, Omicron BA.1) inactivated vaccine or an additional dose of CoronaVac® (heterologous group only). Local and systemic adverse events were recorded for 7 days after immunization with the fifth dose. Blood samples were collected at the time of immunization (day 0), 28 days post-immunization, and 180 days post-immunization. The immune response induced by vaccination was evaluated by quantifying total IgG against SARS-CoV-2 and neutralizing antibodies, IgG-producing B cells, relative antibody avidity, SARS-CoV-2-specific CD4+ and CD8+ T cells, and IFN-γ-producing cells.

RESULTS: The most common local adverse event was pain at the site of inoculation (deltoid area), reported in 43.2% of the participants. No severe adverse events related to vaccination were recorded. Increased SARS-CoV-2-specific IgGs were observed exclusively in the homologous group at 28 days post-vaccination compared to the pre-immune status. Reduced neutralizing antibodies against the Omicron BA.1 variant were detected in both groups when compared to the ancestral (WT) virus, and no changes in IgG-producing B cells or relative antibody avidity were observed after vaccination. Furthermore, we observed sustained IFN-γ production and the frequency of SARS-CoV-2-specific CD4+ and CD8+ T cells before and after vaccination.

CONCLUSIONS: Previous immunizations targeting the WT SARS-CoV-2 virus have induced a robust humoral and cellular response in the population, which is sustained by a fifth dose targeting either the Omicron BA.1, Delta, or WT virus.

TRIAL REGISTRATION: No. NCT05593042.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты