AzTrials
AzTrials

COVID-19Phase 4NCT04756830

A Study to Assess the Safety and Immunogenicity of the Coronavac Vaccine Against COVID-19

A Phase 4 study testing Adsorbed COVID-19 (inactivated) Vaccine in people with COVID-19, run by D'Or Institute for Research and Education at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is an open-label uncontrolled study in which all participants will receive two doses of the inactivated adsorbed vaccine against COVID-19, and will be followed up for safety and immunogenicity analysis for 24 months. 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?
No, everyone receives an active treatment
How many people
1,200 participants
Where
2 sitesBrazil
Study dates
19 Feb 2021to Jun 2023
Phase
Phase 4
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;
  • Agree with study procedures after reading and signing the Informed Consent Form

Who cannot join

  • Pregnancy (confirmed by positive β-hCG test), breastfeeding and / or expressing intention to have sexual practices with reproductive potential without using contraceptive 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 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
  • Any alcohol or drug abuse in the last 12 months prior to inclusion in the study that has caused medical, professional or family problems, as indicated by clinical history;
  • History of severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine;
Show all 17Show fewer
  • History of asplenia;
  • Participation in another clinical trial with product administration under investigation during the six months prior to 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;
  • Use of immunosuppressive therapies six months prior to 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 prior to 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;
  • Have received blood products (transfusions or immunoglobulins) in the last three months before inclusion in the study, or scheduled administration of blood products or immunoglobulin in the two years following inclusion in the study;
  • Suspected or confirmed fever within 72 hours prior to vaccination or axillary temperature greater than 37.8 ° C * on the day of vaccination (inclusion may be postponed until the participant completes 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);
  • Have received vaccine with live attenuated virus in the last 28 days or inactivated vaccine in the last 14 days prior to their inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study;
  • History of bleeding disorders (for example, deficiency of clotting factors, coagulopathy, platelet dysfunction), or previous history of bleeding or significant bruising after IM injection or venipuncture.
  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Hospital Gloria D'Or - Hospitais Integrados da Gavea S/A

    Rio de Janeiro, 22211-230

  • D'Or Institute for Research and Education

    Rio de Janeiro, 22281100

Other trials in Brazil

About this study

Official title: An Open-label Uncontrolled Study to Assess the Safety and Immunogenicity of the Inactivated Adsorbed Vaccine Against COVID-19 (Coronavac) in Individuals Over 18 Years of Age During 24 Months of Follow-up

This is an open-label uncontrolled study in which all participants will receive two doses of the inactivated adsorbed vaccine against COVID-19, and will be followed up for safety and immunogenicity analysis for 24 months.

Read the detailed description

This is an open-label uncontrolled study in which all participants will receive two doses of the inactivated adsorbed vaccine against COVID-19, and will be followed up for safety and immunogenicity analysis for 24 months. This study will assess safety and immunogenicity of the inactivated vaccine adsorbed against COVID-19 (CoronaVac) in a population of healthy individuals older than 18 years of age.

The estimated number of participants is 1200. Participants will be recruited within 3-4 months. The total duration of the study is estimated to be 30 months after recruitment begins.

The participants will remain in the study for approximately 24 months. The study will be carried out at the clinical research center of the D'Or Institute for Research and Education (IDOR) located at the Hospital Glória D'Or, in the city of Rio de Janeiro, RJ, Brazil

Conditions
COVID-19
Being tested
Adsorbed COVID-19 (inactivated) Vaccine
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

    Participants will receive two doses with 14-days interval of adsorbed COVID-19 (inactivated) vaccine

Study groups in NCT04756830
Study groupRoleWhat they receive
VaccinationOtherAll participants will receive two doses of the inactivated adsorbed vaccine against COVID-19.
Receives: Biological: Adsorbed COVID-19 (inactivated) Vaccine

What is being measured

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

  1. Frequency of local and systemic adverse reactions in the first 7 days after immunization

    Frequency of solicited and unsolicited local and systemic adverse reactions in the first 7 days after vaccination per age group (18-59 years old and 60 years old or older), attributed to the vaccine after causality assessment

    Measured: Seven days after each immunization

  2. Seroconversion rates

    Seroconversion rates in the second week after the second dose of the vaccine per age group (18-59 years and 60 years old or older).

    Measured: Two weeks after the second immunization

Secondary outcomes (6)

  1. Frequency of adverse reactions up to 28 days after immunization

    Frequency of unsolicited local and systemic adverse reactions up to 28 days after the second dose of the vaccine per age group (18-59 years old and 60 years old or older), attributed to the vaccine after causality assessment

    Measured: 28 days after the second immunization

  2. Frequency of severe adverse events

    Frequency of severe adverse events after vaccination, attributed to the vaccine after causality assessment

    Measured: Up to 12 months after first immunization

  3. Frequency of adverse events of special interest

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

    Measured: Up to 12 months after first immunization

  4. Cell-mediated immune response

    Cell-mediated immune response at inclusion and four weeks after the second vaccination per age group (18-59 years old and 60 years old or older).

    Measured: At inclusion and 4 weeks after the second vaccination

  5. Frequency of detection of antibodies against SARS-CoV-2

    Frequency of detection of antibodies against SARS-CoV-2 at inclusion, and two weeks, 6 months, 12 months, 18 months and 24 months after the second dose of the vaccine against COVID-19.

    Measured: At inclusion, and two weeks, 6 months, 12 months, 18 months and 24 months after the second vaccination

  6. Geometric mean titer of neutralizing antibodies

    Geometric mean titer of neutralizing antibodies against SARS-CoV-2 at inclusion, and two weeks, 6 months, 12 months, 18 months and 24 months after the second dose of the vaccine against COVID-19.

    Measured: At inclusion, and two weeks, 6 months, 12 months, 18 months and 24 months after the 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 posted16 Feb 2021
  2. Study start19 Feb 2021
  3. Primary completionSep 2021 (estimated)
  4. Study completionJun 2023 (estimated)

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 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04756830
Sponsor's protocol ID
IDOR_VAC_01
Status last verified
Jul 2021
First submitted
15 Feb 2021
Last updated
9 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adsorbed COVID-19 (inactivated) Vaccine in people with COVID-19, run by D'Or Institute for Research and Education at 2 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 2 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: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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?

Frequency of local and systemic adverse reactions in the first 7 days after immunization (time frame: Seven days after each immunization). 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 NCT04756830.

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 9 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in