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CompletedNCT04651790CoronaVac3CLUpdated Feb 2, 2023

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

A Phase 3 interventional study of SARS-CoV-2 inactivated vaccine in Covid19 and Vaccines, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.

Sponsored by Pontificia Universidad Catolica de Chile · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study will evaluate the efficacy, safety, and immunogenicity of two vaccination schedules of an inactivated vaccine against SARS-CoV-2 infection in adults. This study will be performed in 8 centers. Two schedules will be compared: 0,14 and 0,28-day, at a 1:1 rate. 40% of participants will be 60 or more years-old. Follow-up of safety and efficacy will be assessed for 12 months after administering the first dose. The collection of the data will be through an electronic Case Report Form. Immunogenicity will be studied in a subgroup of participants. Initially, 2,300 volunteers will be recruited.

02

Conditions studied

  • Covid19
  • Vaccines

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Keywords

  • Clinical trials
  • Covid19
  • Inactivated vaccine
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 2,300 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 222 studies on the registry; 57 are open to participants now.

Browse Pontificia Universidad Catolica de Chile studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Use of immunosuppressive therapies six months before inclusion in the study or its scheduled use within two years of inclusion. Immunosuppressive therapies will be considered: antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, among others.
  • Have received an immunosuppressive dose of corticosteroids in the last three months before inclusion in the study or scheduled administration of an immunosuppressive dose of corticosteroids for the three months following inclusion in the study. The dose of corticosteroids considered immunosuppressive is equivalent to prednisone at a dose of 20 mg/day for adults for more than a week. The continuous use of topical or nasal corticosteroids is not considered immunosuppressive.
  • 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.
  • Any alcohol or drug abuse in the last 12 months before inclusion in the study that has caused medical, professional, or family problems, as indicated by clinical history.
  • Have received blood products (transfusions or immunoglobulins) in the last three months before inclusion in the study.
  • Have received any vaccine with a live attenuated virus in the last 28 days or inactivated vaccine in the last 14 days before their inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study.
  • Participation in another clinical trial with product administration under investigation during the six months before its inclusion in the study or scheduled participation in another clinical trial in the two years following inclusion.
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,300 participants (actual)

Study arms

  • Active comparator
    Vaccine 0-14

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

    Biological: SARS-CoV-2 inactivated vaccine

  • Experimental
    Vaccine 0-28

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

    Biological: SARS-CoV-2 inactivated vaccine

Interventions

  • BiologicalSARS-CoV-2 inactivated vaccine

    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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: During the first 7 days after each dose of vaccine

  2. 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

    Time frame: Two weeks after second dose up to one year after first dose

Secondary outcomes

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

    The incidence of hospitalized cases of COVID-19 two weeks after the second vaccination of two vaccination schedules will be determined.

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

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

    The incidence of severe cases of COVID-19 and deaths, confirmed through PCR, two weeks after the second vaccination of two vaccination schedules, will be determined.

    Time frame: Since two weeks after the second dose up 12 month after first dose

  3. 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)

    The incidence of adverse reactions to the vaccine, both local and systemic, solicited and unsolicited will be determined. These adverse reactions will be measured within the period of four weeks after each dose of vaccination of two vaccination schedules. These adverse reactions will be registered according to the age group in adult (18-59 years old) and elder (60 years of age or older) subjects

    Time frame: Four weeks after each dose of vaccine in two vaccination schedules

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

    The frequency of severe COVID-19 cases in participants who received at least one dose of vaccine in two vaccination schedules will be determined.

    Time frame: Since first dose up to 12 month after

  5. 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

    The occurrence of serious adverse events (SAE) and adverse events of special interest in participants who have received at least one dose of the vaccine in two vaccination schedules, will be determined

    Time frame: Since first dose up to 12 month after

  6. Percentage of participants that show a significant increase in SARS-CoV-2 specific T cells after vaccination, in two vaccination schedules, determined by flow Cytometry and ELISPOT

    The cellular immune response in a subgroup of participants, before and two and four weeks after the administration of each dose of the vaccine, in two vaccination schedules will be evaluated

    Time frame: Since first dose up to 4 weeks after second dose

  7. Percentage of participants with a significant increase of anti-SARS-CoV-2 antibodies, determined by ELISA

    The presence of anti-SARS-CoV-2 antibodies in a subgroup of participants, before and two weeks after the administration of each dose of the vaccine, in two vaccination schedules, will be evaluated.

    Time frame: Since first dose up to 2 weeks after second dose

  8. Percentage of participants that show a significant increase in SARS-CoV-2 specific T cells after vaccination, determined by flow Cytometry and ELISPOT

    The cellular immune response in a subgroup of participants, before and two and four weeks after the administration of each dose of the vaccine, will be evaluated.

    Time frame: Since first dose up to 4 weeks after second dose

07

Study locations

1 site
  • Centro de Especialidades Médicas, Red de Salud UC Christus
    Santiago, RM 7770228, Chile
08

References and documents

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. PubMed 36226829 ↗
  • 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. PubMed 35464483 ↗
  • 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. PubMed 35441164 ↗
  • 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. PubMed 34659237 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2020 to primary completion in Aug 2022, 20 months.

Of 279 non-industry phase 3 interventional studies under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 20 months is above that.

Counting every sponsor, half of 436 studies reached it within 9 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2020
First posted
Dec 3, 2020
StartActual
Nov 27, 2020
Primary completionActual
Aug 1, 2022
CompletionActual
Nov 1, 2022
Last update
Feb 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04651790
Lead sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Ministry of Health, Chile, Sinovac Biotech Co., Ltd
Responsible party
Sponsor
First posted
Dec 3, 2020
Start date
Nov 27, 2020
Primary completion
Aug 1, 2022
Completion
Nov 1, 2022
Last update
Feb 2, 2023

Study contacts

Katia Abarca, MD
study director · Pontificia Universidad Catolica de Chile
Alexis M Kalergis, PhD
study director · Pontificia Universidad Catolica de Chile
Susan M Bueno, PhD
study director · Pontificia Universidad Catolica de Chile
Pablo A González, PhD
study director · Pontificia Universidad Catolica de Chile

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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