Efficacy, Safety, and Immunogenicity of Two Vaccination Schedules of an Inactivated Vaccine Against COVID-19 in Adults

Summary

The study will evaluate the efficacy, safety, and immunogenicity of two vaccination schedules of an inactivated vaccine against SARS-CoV-2 infection in adults. Two doses of the vaccine will be administered in a 0,14 and a 0,28-day schedule. Follow-up of safety and efficacy will be assessed for 12 months after the first dose. Immunogenicity will be studied in a subgroup of participants.

Timeline

Start

2020-11-27

Primary completion

2022-08-01

Completion

2022-11-01

Publications

• Galvez NMS, Pacheco GA, Schultz BM, Melo-Gonzalez F, Soto JA, Duarte LF, Gonzalez LA, Rivera-Perez D, Rios M, Berrios RV, Vazquez Y, Moreno-Tapia D, Vallejos OP, Andrade CA, Hoppe-Elsholz G, Iturriaga C, Urzua M, Navarrete MS, Rojas A, Fasce R, Fernandez J, Mora J, Ramirez E, Gaete-Argel A, Acevedo ML, Valiente-Echeverria F, Soto-Rifo R, Weiskopf D, Grifoni A, Sette A, Zeng G, Meng W; CoronaVacCL03 Study Group; Gonzalez-Aramundiz JV, Johnson M, Goldblatt D, Gonzalez PA, Abarca K, Bueno SM, Kalergis AM. Differences in the immune response elicited by two immunization schedules with an inactivated SARS-CoV-2 vaccine in a randomized phase 3 clinical trial. Elife. 2022 Oct 13;11:e81477. doi: 10.7554/eLife.81477.
• Luan N, Li T, Wang Y, Cao H, Yin X, Lin K, Liu C. Th2-Oriented Immune Serum After SARS-CoV-2 Vaccination Does Not Enhance Infection In Vitro. Front Immunol. 2022 Apr 8;13:882856. doi: 10.3389/fimmu.2022.882856. eCollection 2022.
• Bueno SM, Abarca K, Gonzalez PA, Galvez NM, Soto JA, Duarte LF, Schultz BM, Pacheco GA, Gonzalez LA, Vazquez Y, Rios M, Melo-Gonzalez F, Rivera-Perez D, Iturriaga C, Urzua M, Dominguez A, Andrade CA, Berrios RV, Canedo-Marroquin G, Covian C, Moreno-Tapia D, Saavedra F, Vallejos OP, Donato P, Espinoza P, Fuentes D, Gonzalez M, Guzman P, Munoz-Venturelli P, Perez CM, Potin M, Rojas A, Fasce R, Fernandez J, Mora J, Ramirez E, Gaete-Argel A, Oyarzun-Arrau A, Valiente-Echeverria F, Soto-Rifo R, Weiskopf D, Sette A, Zeng G, Meng W, Gonzalez-Aramundiz JV, Kalergis AM. Interim report: Safety and immunogenicity of an inactivated vaccine against SARS-CoV-2 in healthy chilean adults in a phase 3 clinical trial. medRxiv [Preprint]. 2021 Apr 1:2021.03.31.21254494. doi: 10.1101/2021.03.31.21254494.
• Duarte LF, Galvez NMS, Iturriaga C, Melo-Gonzalez F, Soto JA, Schultz BM, Urzua M, Gonzalez LA, Vazquez Y, Rios M, Berrios-Rojas RV, Rivera-Perez D, Moreno-Tapia D, Pacheco GA, Vallejos OP, Hoppe-Elsholz G, Navarrete MS, Rojas A, Fasce RA, Fernandez J, Mora J, Ramirez E, Zeng G, Meng W, Gonzalez-Aramundiz JV, Gonzalez PA, Abarca K, Bueno SM, Kalergis AM. Immune Profile and Clinical Outcome of Breakthrough Cases After Vaccination With an Inactivated SARS-CoV-2 Vaccine. Front Immunol. 2021 Sep 29;12:742914. doi: 10.3389/fimmu.2021.742914. eCollection 2021.

Drugs

Indications