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COVID-19Phase 3PROFISCOVNCT04456595

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

A Phase 3 study testing Adsorbed COVID-19 (inactivated) Vaccine in people with COVID-19, run by Butantan Institute at 16 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Adsorbed COVID-19 (inactivated) Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12,688 participants
Where
16 sitesBrazil
Study dates
21 Jul 2020to 17 Feb 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
  • 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 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;
  • 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;
  • 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;
  • History of severe allergic reactions or anaphylaxis to the study vaccine or to components thereof;
Show all 17Show fewer
  • History of asplenia;
  • 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;
  • Previous participation in a study to evaluate a COVID-19 vaccine or prior exposure to a COVID-19 vaccine;
  • 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.
  • 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;
  • 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;
  • 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);
  • 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);
  • 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;
  • 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
  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Brazil16 sites

  • Hospital de Amor - Fundação Pio XII

    Barretos, São Paulo, 14780-070

  • Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30750-140

  • Universidade de Brasília

    Brasília, Federal District, 71691-082

  • Hospital das Clínicas da UNICAMP

    Campinas, São Paulo, 13083-888

  • Hospital Universitário Maria Aparecida Pedrossian

    Campo Grande, Mato Grosso do Sul, 79080-190

  • Hospital Universitário Júlio Müller

    Cuiabá, Mount, 78048-902

  • Hospital das Clínicas da Universidade Federal do Paraná

    Curitiba, Paraná, 80060-900

  • Hospital Escola da Universidade Federal de Pelotas

    Pelotas, Rio Grande do Sul, 96020-360

  • Hospital São Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90619-900

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

    Ribeirão Preto, São Paulo, 14015-069

  • Instituto de Infectologia Evandro Chagas - Fiocruz

    Rio de Janeiro, 21710-232

  • Universidade Municipal de São Caetano do Sul

    São Caetano do Sul, São Paulo, 09521-160

  • Faculdade de Medicina de São José do Rio Preto - FAMERP

    São José do Rio Preto, São Paulo, 15090-000

  • Instituto de Infectologia Emílio Ribas

    São Paulo, São Paulo, 01246-900

  • Centro de Pesquisas Clínicas do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, São Paulo, 05403 000

  • Instituto Israelita de Ensino e Pesquisa Albert Einstein

    São Paulo, São Paulo, 05652-900

Other trials in Brazil

About this study

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

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

Read the 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.

Conditions
COVID-19
Being tested
Adsorbed COVID-19 (inactivated) Vaccine, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adsorbed COVID-19 (inactivated) VaccineBiological

    Also called CoronaVac

    Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac

  • PlaceboBiological

    Placebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac

Study groups in NCT04456595
Study groupRoleWhat they receive
Adult - VaccineExperimentalParticipants aging 18-59 years receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine
Receives: Biological: Adsorbed COVID-19 (inactivated) Vaccine
Elderly - VaccineExperimentalParticipants aging 60 years or above receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine
Receives: Biological: Adsorbed COVID-19 (inactivated) Vaccine
Adult - PlaceboPlacebo comparatorParticipants aging 18-59 years receiving two doses with 14-days interval of placebo
Receives: Biological: Placebo
Elderly - PlaceboPlacebo comparatorParticipants aging 60 years or above receiving two doses with 14-days interval of placebo
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of COVID-19 cases after two-doses immunization schedule

    Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine

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

  2. Frequency of adverse events up to seven days after immunization

    Frequency of adverse reaction in the seven days following each immunization per age group

    Measured: Seven days after each immunization

Secondary outcomes (10)

  1. Incidence of COVID-19 cases after two-doses immunization schedule according to previous exposure

    Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine according to previous exposure to SARS-CoV-2

    Measured: Two weeks after first dose up to one year after first dose

  2. Incidence of COVID-19 cases after 14-days of first immunization

    Number of virologically-confirmed symptomatic COVID-19 two weeks after first dose of vaccine, regardless the vaccination schedule was completed

    Measured: Two weeks after last dose uup to one year after first dose

  3. Combined incidence of SARS-CoV-2 infection

    Number of virologically-confirmed and or serologically-confirmed SARS-CoV-2 infections two weeks after first dose of vaccine

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

  4. Incidence of severe COVID-19 cases after two-doses immunization schedule

    Number of virologically-confirmed severe COVID-19 two weeks after second dose of vaccine

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

  5. Frequency of adverse events up to 28 days after immunization

    Frequency of adverse reaction in the 28 days following each immunization per age group

    Measured: 28 days after each immunization

  6. Frequency of severe COVID-19 cases

    Frequency of virologically-confirmed severe COVID-19 cases after receiving, at least, one dose of the vaccine

    Measured: From first vaccination up to one year after first dose

  7. Frequency of adverse events of special interest after immunization

    Frequency of adverse events of special interest after receiving, at least, one dose of the vaccine

    Measured: From first vaccination up to one year after first dose

  8. Seroconversion rate

    Number of seroconversion responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants

    Measured: Two weeks after each vaccination

  9. Cell-mediated immune profile

    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

    Measured: Two and four weeks afer each vaccination

  10. Seropositivity rate

    Number of seropositive responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants

    Measured: Two weeks after second vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2020
  2. Study start21 Jul 2020
  3. Primary completion17 Dec 2020
  4. Study completion17 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12,688 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04456595
Sponsor's protocol ID
COV-02-IB
Acronym
PROFISCOV
Status last verified
Feb 2024
First submitted
30 Jun 2020
Last updated
15 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Palacios R, Patino 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.

    PubMed 33059771

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adsorbed COVID-19 (inactivated) Vaccine in people with COVID-19, run by Butantan Institute at 16 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of COVID-19 cases after two-doses immunization schedule (time frame: Two weeks after second dose up to one year after first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04456595, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.

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