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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 : October 20, 2020
Sponsor:
Collaborator:
Sinovac Life Sciences Co., Ltd.
Information provided by (Responsible Party):
Butantan Institute

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

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Adsorbed COVID-19 (inactivated) Vaccine Biological: Placebo Phase 3

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 150 cases.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13060 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adult - Vaccine
Participants aging 18-59 years receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine
Biological: Adsorbed COVID-19 (inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Other Name: CoronaVac

Experimental: Elderly - Vaccine
Participants aging 60 years or above receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine
Biological: Adsorbed COVID-19 (inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
Other Name: CoronaVac

Placebo Comparator: Adult - Placebo
Participants aging 18-59 years receiving two doses with 14-days interval of placebo
Biological: Placebo
Placebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac

Placebo Comparator: Elderly - Placebo
Participants aging 60 years or above receiving two doses with 14-days interval of placebo
Biological: Placebo
Placebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456595


Contacts
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Contact: Ricardo Palacios, MD, PhD 551137232121 ricardo.palacios@butantan.gov.br

Locations
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Brazil
Universidade de Brasília Recruiting
Brasilia, DF, Brazil, 71691-082
Contact: Gustavo Adolfo Sierra Romero, MD, PhD         
Principal Investigator: Gustavo Adolfo Sierra Romero, MD, PhD         
Universidade Federal de Minas Gerais Recruiting
Belo Horizonte, MG, Brazil, 30750-140
Contact: Mauro M Teixeira, MD, PhD         
Principal Investigator: Mauro M Teixeira, MD, PhD         
Hospital Universitário Júlio Müller Recruiting
Cuiabá, Mount, Brazil, 78048-902
Contact: Cor J Fontes, MD, PhD         
Hospital Universitário Maria Aparecida Pedrossian Recruiting
Campo Grande, MS, Brazil, 79080-190
Contact: Ana Lúcia Lyrio de Oliveira, MD, PhD         
Hospital das Clínicas da Universidade Federal do Paraná Recruiting
Curitiba, PR, Brazil, 80060-900
Contact: Sonia Raboni, MD, PhD         
Principal Investigator: Sonia Raboni, MD, PhD         
Hospital Escola da Universidade Federal de Pelotas Recruiting
Pelotas, RS, Brazil, 96020-360
Contact: Danise S Oliveira, MD, PhD         
Hospital São Lucas da Pontificia Universidade Catolica do Rio Grande do Sul Recruiting
Porto Alegre, RS, Brazil, 90619-900
Contact: Fabiano Ramos, MD         
Contact: PhD         
Principal Investigator: Fabiano Ramos, MD         
Hospital de Amor - Fundação Pio XII Recruiting
Barretos, SP, Brazil, 14780-070
Contact: Gecilmara Cristina S Pileggi, MD, PhD         
Hospital das Clínicas da UNICAMP Recruiting
Campinas, SP, Brazil, 13083-888
Contact: Francisco H Aoki, MD, PhD         
Principal Investigator: Francisco H Aoki, MD, PhD         
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo Recruiting
Ribeirao Preto, SP, Brazil, 14015-069
Contact: Eduardo B Coelho, MD,PhD         
Principal Investigator: Eduardo B Coelho, MD, PhD         
Instituto de Infectologia Emílio Ribas Recruiting
Sao Paulo, SP, Brazil, 01246-900
Contact: Luiz Carlos Pereira Júnior, MD, PhD         
Principal Investigator: Luiz Carlos Pereira Júnior, MD, PhD         
Centro de Pesquisas Clínicas do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
Sao Paulo, SP, Brazil, 05403 000
Contact: Esper Kallas, MD,PhD         
Principal Investigator: Esper Kallas, MD,PhD         
Instituto Israelita de Ensino e Pesquisa Albert Einstein Recruiting
Sao Paulo, SP, Brazil, 05652-900
Contact: Luis Fernando Aranha Camargo, MD, PhD         
Principal Investigator: Luis Fernando Aranha Camargo, MD, PhD         
Universidade Municipal de São Caetano do Sul Recruiting
São Caetano do Sul, SP, Brazil, 09521-160
Contact: Fábio E Leal, MD, PhD         
Principal Investigator: Fábio E Leal, MD, PhD         
Faculdade de Medicina de São José do Rio Preto - FAMERP Recruiting
São José Do Rio Preto, São Paulo, Brazil, 15090-000
Contact: Maurício L Nogueira, MD, PhD         
Principal Investigator: Maurício L Nogueira, MD, PhD         
Instituto de Infectologia Evandro Chagas - Fiocruz Recruiting
Rio De Janeiro, Brazil, 21710-232
Contact: André Siqueira, MD, PhD         
Principal Investigator: André Siqueira, MD, PhD         
Sponsors and Collaborators
Butantan Institute
Sinovac Life Sciences Co., Ltd.
Investigators
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Study Director: Ricardo Palacios, MD, PhD Butantan Institute
Publications:
Palacios, R., Patiño, E.G., de Oliveira Piorelli, R. et al. 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 21, 853 (2020). https://doi.org/10.1186/s13063-020-04775-4

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Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT04456595    
Other Study ID Numbers: COV-02-IB
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No