TY - JOUR
T1 - Differences in the immune response elicited by two immunization schedules with an inactivated SARS-CoV-2 vaccine in a randomized phase 3 clinical trial
AU - Gálvez, Nicolás M.S.
AU - Pacheco, Gaspar A.
AU - Schultz, Bárbara M.
AU - Melo-González, Felipe
AU - Soto, Jorge A.
AU - Duarte, Luisa F.
AU - González, Liliana A.
AU - Rivera-Pérez, Daniela
AU - Ríos, Mariana
AU - Berrios, Roslye V.
AU - Vázquez, Yaneisi
AU - Moreno-Tapia, Daniela
AU - Vallejos, Omar P.
AU - Andrade, Catalina A.
AU - Hoppe-Elsholz, Guillermo
AU - Iturriaga, Carolina
AU - Urzua, Marcela
AU - Navarrete, María S.
AU - Rojas, Álvaro
AU - Fasce, Rodrigo
AU - Fernández, Jorge
AU - Mora, Judith
AU - Ramírez, Eugenio
AU - Gaete-Argel, Aracelly
AU - Acevedo, Mónica L.
AU - Valiente-Echeverría, Fernando
AU - Soto-Rifo, Ricardo
AU - Weiskopf, Daniela
AU - Grifoni, Alba
AU - Sette, Alessandro
AU - Zeng, Gang
AU - Meng, Weining
AU - González-Aramundiz, José V.
AU - Johnson, Marina
AU - Goldblatt, David
AU - González, Pablo A.
AU - Abarca, Katia
AU - Bueno, Susan M.
AU - Kalergis, Alexis M.
N1 - Publisher Copyright:
© Gálvez, Pacheco, Schultz et al.
PY - 2022
Y1 - 2022
N2 - Background: The development of vaccines to control the coronavirus disease 2019 (COVID-19) pandemic progression is a worldwide priority. CoronaVac is an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine approved for emergency use with robust efficacy and immunogenicity data reported in trials in China, Brazil, Indonesia, Turkey, and Chile. Methods: This study is a randomized, multicenter, and controlled phase 3 trial in healthy Chilean adults aged ≥18 years. Volunteers received two doses of CoronaVac separated by 2 (0–14 schedule) or 4 weeks (0–28 schedule); 2302 volunteers were enrolled, 440 were part of the immunogenicity arm, and blood samples were obtained at different times. Samples from a single center are reported. Humoral immune responses were evaluated by measuring the neutralizing capacities of circulating antibodies. Cellular immune responses were assessed by ELISPOT and flow cytometry. Correlation matrixes were performed to evaluate correlations in the data measured. Results: Both schedules exhibited robust neutralizing capacities with the response induced by the 0–28 schedule being better. No differences were found in the concentration of antibodies against the virus and different variants of concern (VOCs) between schedules. Stimulation of peripheral blood mononuclear cells (PBMCs) with Mega pools of Peptides (MPs) induced the secretion of interferon (IFN)-γ and the expression of activation induced markers in CD4+ T cells for both schedules. Correlation matrixes showed strong correlations between neutralizing antibodies and IFN-γ secretion. Conclusions: Immunization with CoronaVac in Chilean adults promotes robust cellular and humoral immune responses. The 0–28 schedule induced a stronger humoral immune response than the 0–14 schedule.
AB - Background: The development of vaccines to control the coronavirus disease 2019 (COVID-19) pandemic progression is a worldwide priority. CoronaVac is an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine approved for emergency use with robust efficacy and immunogenicity data reported in trials in China, Brazil, Indonesia, Turkey, and Chile. Methods: This study is a randomized, multicenter, and controlled phase 3 trial in healthy Chilean adults aged ≥18 years. Volunteers received two doses of CoronaVac separated by 2 (0–14 schedule) or 4 weeks (0–28 schedule); 2302 volunteers were enrolled, 440 were part of the immunogenicity arm, and blood samples were obtained at different times. Samples from a single center are reported. Humoral immune responses were evaluated by measuring the neutralizing capacities of circulating antibodies. Cellular immune responses were assessed by ELISPOT and flow cytometry. Correlation matrixes were performed to evaluate correlations in the data measured. Results: Both schedules exhibited robust neutralizing capacities with the response induced by the 0–28 schedule being better. No differences were found in the concentration of antibodies against the virus and different variants of concern (VOCs) between schedules. Stimulation of peripheral blood mononuclear cells (PBMCs) with Mega pools of Peptides (MPs) induced the secretion of interferon (IFN)-γ and the expression of activation induced markers in CD4+ T cells for both schedules. Correlation matrixes showed strong correlations between neutralizing antibodies and IFN-γ secretion. Conclusions: Immunization with CoronaVac in Chilean adults promotes robust cellular and humoral immune responses. The 0–28 schedule induced a stronger humoral immune response than the 0–14 schedule.
UR - http://www.scopus.com/inward/record.url?scp=85141521094&partnerID=8YFLogxK
U2 - 10.7554/eLife.81477
DO - 10.7554/eLife.81477
M3 - Article
C2 - 36226829
AN - SCOPUS:85141521094
SN - 2050-084X
VL - 11
JO - eLife
JF - eLife
M1 - e81477
ER -