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Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare Professionals (PROFISCOV)

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ClinicalTrials.gov Identifier: NCT04456595
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : December 11, 2020
Sponsor:
Collaborator:
Sinovac Life Sciences Co., Ltd.
Information provided by (Responsible Party):
Butantan Institute

Tracking Information
First Submitted Date  ICMJE June 30, 2020
First Posted Date  ICMJE July 2, 2020
Last Update Posted Date December 11, 2020
Actual Study Start Date  ICMJE July 21, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
  • Incidence of COVID-19 cases after two-doses immunization schedule [ Time Frame: Two weeks after second dose up to one year after first dose ]
    Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine
  • Frequency of adverse events up to seven days after immunization [ Time Frame: Seven days after each immunization ]
    Frequency of adverse reaction in the seven days following each immunization per age group
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2020)
  • Incidence of COVID-19 cases after two-doses immunization schedule according to previous exposure [ Time Frame: Two weeks after first dose up to one year after first dose ]
    Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine according to previous exposure to SARS-CoV-2
  • Incidence of COVID-19 cases after 14-days of first immunization [ Time Frame: Two weeks after last dose uup to one year after first dose ]
    Number of virologically-confirmed symptomatic COVID-19 two weeks after first dose of vaccine, regardless the vaccination schedule was completed
  • Combined incidence of SARS-CoV-2 infection [ Time Frame: Two weeks after second dose up to one year after first dose ]
    Number of virologically-confirmed and or serologically-confirmed SARS-CoV-2 infections two weeks after first dose of vaccine
  • Incidence of severe COVID-19 cases after two-doses immunization schedule [ Time Frame: Two weeks after second dose up to one year after first dose ]
    Number of virologically-confirmed severe COVID-19 two weeks after second dose of vaccine
  • Frequency of adverse events up to 28 days after immunization [ Time Frame: 28 days after each immunization ]
    Frequency of adverse reaction in the 28 days following each immunization per age group
  • Frequency of severe COVID-19 cases [ Time Frame: From first vaccination up to one year after first dose ]
    Frequency of virologically-confirmed severe COVID-19 cases after receiving, at least, one dose of the vaccine
  • Frequency of adverse events of special interest after immunization [ Time Frame: From first vaccination up to one year after first dose ]
    Frequency of adverse events of special interest after receiving, at least, one dose of the vaccine
  • Seroconversion rate [ Time Frame: Two weeks after each vaccination ]
    Number of seroconversion responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants
  • Cell-mediated immune profile [ Time Frame: Two and four weeks afer each vaccination ]
    Number of cell-mediated immune response against SARS-CoV-2 in the week two and four after the second vaccination per age group in a subset of participants
  • Seropositivity rate [ Time Frame: Two weeks after second vaccination ]
    Number of seropositive responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
  • Incidence of COVID-19 cases after 14-days of first immunization [ Time Frame: Two weeks after first dose up to one year after first dose ]
    Number of virologically-confirmed symptomatic COVID-19 two weeks after first dose of vaccine
  • Incidence of COVID-19 cases after 14-days of last immunization [ Time Frame: Two weeks after last dose uup to one year after first dose ]
    Number of virologically-confirmed symptomatic COVID-19 two weeks after last dose of vaccine, regardless the vaccination schedule was completed
  • Combined incidence of SARS-CoV-2 infection [ Time Frame: Two weeks after second dose up to one year after first dose ]
    Number of virologically-confirmed and or serologically-confirmed SARS-CoV-2 infections two weeks after first dose of vaccine
  • Frequency of adverse events up to 28 days after immunization [ Time Frame: 28 days after each immunization ]
    Frequency of adverse reaction in the 28 days following each immunization per age gropu
  • Incidence of severe COVID-19 cases [ Time Frame: From first vaccination up to one year after first dose ]
    Number of virologically-confirmed severe COVID-19 cases after receiving, at least, one dose of the vaccine
  • Seroconversion rate [ Time Frame: Two weeks afer each vaccination ]
    Number of seroconversion responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants
  • Cell-mediated immune profile [ Time Frame: Two and four weeks afer each vaccination ]
    Number of cell-mediated immune response against SARS-CoV-2 in the week two and four after the second vaccination per age group in a subset of participants
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare Professionals
Official Title  ICMJE Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate Efficacy and Safety in Healthcare Professionals of the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac
Brief Summary This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac in health care professionals
Detailed Description

This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac in health care professionals.

The study will be double-blind placebo-controlled trial with participants randomly allocated 1:1 to placebo and vaccine arms.

The immunization schedule is two doses intramuscular injections (deltoid) with a 14-days interval.

For efficacy, the study aims to detect COVID-19 cases, defined as symptomatic SARS-CoV-2 infections, after the second week post-immunization schedule.

For safety and immunogenicity, participants are categorized in two age groups, Adults (18-59 years) and Elderly (60 years and above). Safety database aims to detect adverse reactions with frequency of 1:1000 or higher in adults and 1:500 in elderly.

All participants will be followed up to 12 months. Interim preliminary efficacy analysis can be triggered by reaching the target number of 61 cases. Primary efficacy analysis requires 151 cases.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Adsorbed COVID-19 (inactivated) Vaccine
    Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
    Other Name: CoronaVac
  • Biological: Placebo
    Placebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Study Arms  ICMJE
  • Experimental: Adult - Vaccine
    Participants aging 18-59 years receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine
    Intervention: Biological: Adsorbed COVID-19 (inactivated) Vaccine
  • Experimental: Elderly - Vaccine
    Participants aging 60 years or above receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine
    Intervention: Biological: Adsorbed COVID-19 (inactivated) Vaccine
  • Placebo Comparator: Adult - Placebo
    Participants aging 18-59 years receiving two doses with 14-days interval of placebo
    Intervention: Biological: Placebo
  • Placebo Comparator: Elderly - Placebo
    Participants aging 60 years or above receiving two doses with 14-days interval of placebo
    Intervention: Biological: Placebo
Publications * Palacios R, Patiño EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 15;21(1):853. doi: 10.1186/s13063-020-04775-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2020)
13060
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2020)
8870
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults 18 years of age or older;
  2. Healthcare professionals who work in direct contact care of people with possible or confirmed COVID-19 cases;
  3. Agree with periodic contacts by phone or electronic means, and home visits;
  4. Show voluntary intention to participate in the study, documented by the informed consent form signed by participant.

Exclusion Criteria:

  1. For females: Pregnancy (confirmed by positive beta-hCG test), breastfeeding or intent to engage in sexual relations with reproductive intent without use of birth control methods in the three months following vaccination;
  2. 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;
  3. Diseases with impaired immune system including: neoplasms (except basal cell carcinoma), congenital or acquired immunodeficiencies and autoimmune diseases not controlled 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;
  4. Behavioral, cognitive or psychiatric disease that, in the opinion of the principal investigator or his or her representative physician, affects the participant's ability to understand and cooperate with all study protocol requirements;
  5. Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has caused medical, professional or family problems, indicated by clinical history;
  6. History of severe allergic reactions or anaphylaxis to the study vaccine or to components thereof;
  7. History of asplenia;
  8. Participation in another clinical trial with an investigational product in the six months prior to enrollment in the study or planned participation in another clinical trial within the two years following enrollment;
  9. Previous participation in a study to evaluate a COVID-19 vaccine or prior exposure to a COVID-19 vaccine;
  10. Use of immunosuppressant therapy regimens within the six months prior to enrollment in the study for planned use within the two years following enrollment. Immunosuppressant therapy regimens include: antineoplastic chemotherapy, radiation therapy and immunosuppressants to induce transplant tolerance, among others.
  11. Use of immunosuppressive doses of corticosteroids within the three months prior to the enrollment in the study and planned use of immunosuppressive doses of corticoids within the three months following enrollment in the study. Immunosuppressive doses of corticosteroids will be considered the equivalent prednisone 20 mg/day for adults, for longer than one week. Continued use of topical or nasal corticosteroids is not considered an immunosuppressant;
  12. Received blood products (transfusions or immunoglobulins) within the three months prior to enrollment in the study, or planned administration of blood products or immunoglobulins within the two years following enrollment in the study;
  13. Suspected or confirmed fever within the 72 hours prior to vaccination or axillary temperature greater than 37.8 °C* on the day of vaccination (enrollment may be postponed until participant has gone 72 hours without fever);
  14. Possible or confirmed case of COVID-19 on the day of vaccination (vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
  15. Received live attenuated virus vaccine or inactivated vaccine within the 28 days or 14 days, respectively, prior to enrollment in the study, or immunization planned within the 28 days after enrollment in the study;
  16. History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
  17. Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ricardo Palacios, MD, PhD 551137232121 ricardo.palacios@butantan.gov.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04456595
Other Study ID Numbers  ICMJE COV-02-IB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Butantan Institute
Study Sponsor  ICMJE Butantan Institute
Collaborators  ICMJE Sinovac Life Sciences Co., Ltd.
Investigators  ICMJE
Study Director: Ricardo Palacios, MD, PhD Butantan Institute
PRS Account Butantan Institute
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP