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

NCT04651790 | Completed Phase 3 DMC

• 1 other identifier: 200708006
• Study Type: interventional
• Target: 2,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Vaccines

Keywords

Clinical trials; Covid19; Inactivated vaccine

Outcome Measures

Primary Outcomes (2)

• Frequency of solicited and unsolicited adverse events that occur during the period of one week after each dose of the vaccine in two vaccination schedules: 0,14 and 0,28 days stratified by age group (18-59 years, and 60 or more years).

  The frequency of solicited and unsolicited local and systemic adverse reactions will be registered. This will be measured during the first 7 days after each vaccination. These adverse reactions will be registered according to the age group in adults (18-59 years old) and the elderly (60 years of age or older).

  During the first 7 days after each dose of vaccine

• Incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second dose of each vaccination schedule.

  Vaccine efficacy to prevent virologically confirmed COVID-19 two weeks after the second dose of each vaccination schedule will be determined

  Two weeks after second dose up to one year after first dose

Secondary Outcomes (8)

• Incidence of hospitalized cases of COVID-19 two weeks after the second vaccination of two vaccination schedules

  Since two weeks after the second dose of two vaccination schedules and up 12 month after first dose

• Incidence of severe cases or deaths of COVID-19 virologically confirmed two weeks after the second vaccination of two vaccination schedules

  Since two weeks after the second dose up 12 month after first dose

• Incidence of adverse reactions to the vaccine, local and systemic, solicited and unsolicited, within the period of four weeks after each vaccination of two vaccination schedules, according to the age, adults (18-59 years old) and elder (>60 years)

  Four weeks after each dose of vaccine in two vaccination schedules

• Frequency of severe COVID-19 cases in participants who received at least one dose of vaccine in two vaccination schedules

  Since first dose up to 12 month after

• Incidence of serious adverse events (SAE) and adverse events in participants who have received at least one dose of the vaccine, in two vaccination schedules

  Since first dose up to 12 month after

Study Arms (2)

Vaccine 0-14

ACTIVE COMPARATOR

Inactivated vaccine against SARS-CoV-2 2 doses on day 0 and 14

Biological: SARS-CoV-2 inactivated vaccine

Vaccine 0-28

EXPERIMENTAL

Inactivated vaccine against SARS-CoV-2 2 doses on day 0 and 28

Biological: SARS-CoV-2 inactivated vaccine

Interventions

SARS-CoV-2 inactivated vaccine BIOLOGICAL

The vaccine contains inactivated SARS-CoV-2 virus, aluminum hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate and sodium chloride.The final product will be supplied in a pre-filled syringe containing 0.5 ml of solution for injection that corresponds to a dose of the vaccine.

Also known as: Coronavac

Vaccine 0-14; Vaccine 0-28

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years of age.
• Demonstrate the capacity to understand and sign the Informed Consent document.
• Agree to comply with the study procedures and visits.

You may not qualify if:

• History of confirmed symptomatic SARS CoV-2 infection.
• Pregnant (confirmed by positive urine pregnancy test) or breastfeeding females, and/or expressing intention to have sexual practices with reproductive potential without using contraceptive methods in the three months following vaccination.
• History of an allergic reaction to the vaccine or components of the study vaccine or placebo.
• Evidence of uncontrolled neurological, cardiac, pulmonary, hepatic, or renal disease, according to anamnesis or physical examination; Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease.
• Diseases that impair the immune system including neoplasms (except basal cell carcinoma), congenital or acquired immunodeficiencies, and uncontrolled autoimmune diseases not controlled according to anamnesis or physical examination.
• Behavioral, cognitive, or psychiatric illness that, in the opinion of the principal investigator or his medical representative, affects the participant's ability to understand and collaborate with the requirements of the study protocol.
• History of asplenia, either anatomic or functional.
• History of bleeding disorders, as deficiency of clotting factors, coagulopathy, platelet dysfunction, or previous history of bleeding or significant bruising after IM injection or venipuncture.
• Previous participation in a COVID-19 vaccine evaluation study or previous exposure to a COVID-19 vaccine.
• Fever (\>37.8°C) within 72 hours before vaccination.
• Any other condition that, in the opinion of the principal investigator or his medical representative, could jeopardize the safety or rights of a potential participant or that would prevent him from complying with this protocol.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Ministry of Health, Chile: collaborator
• Sinovac Biotech Co., Ltd: collaborator

Study Sites (1)

Centro de Especialidades Médicas, Red de Salud UC Christus

Santiago, RM, 7770228, Chile

Location

Related Publications (4)

• 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.

  PMID: 36226829 DERIVED

• 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.

  PMID: 35464483 DERIVED

• 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.

  PMID: 35441164 DERIVED

• 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.

  PMID: 34659237 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Katia Abarca, MD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

• Alexis M Kalergis, PhD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

• Susan M Bueno, PhD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

• Pablo A González, PhD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 3, 2020
• Study Start: November 27, 2020
• Primary Completion: August 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 2, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)