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AzTrials

COVID-19 Virus InfectionPhase 3NCT04560881

Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (COVID-19)

A Phase 3 study testing Inactivated SARS-CoV-2 vaccine (Vero cell) in people with COVID-19 Virus Infection, run by Laboratorio Elea Phoenix S.A. at 4 sites in Argentina.

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 randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 Virus Infection
What is being tested?
Inactivated SARS-CoV-2 vaccine (Vero cell)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,000 participants
Where
4 sitesArgentina
Study dates
16 Sep 2020to 13 Dec 2021
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 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy subjects aged between 18 and 85 years old.
  • By asking for medical history and physical examination, the investigator judged that the health condition is well.
  • Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
  • During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
  • With self-ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

Who cannot join

  • Active Sars-Cov-2 Infection measured by RT-qPCR
  • Has a history of SARS, MERS infection (self-report, on-site inquiry)
  • Has clinical manifestation of fever (axillary temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
  • Body temperature > 37.0 ℃ before vaccination
  • Urine pregnancy test positive;
  • Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
Show all 18Show fewer
  • Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
  • With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • With severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
  • Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
  • With known or suspected diseases include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors.
  • Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease)
  • Receiving anti-TB therapy.
  • Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days)
  • Inoculated live attenuated vaccines within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
  • Received blood products within 3 months before this vaccination
  • Received other research drugs within 6 months before this vaccination.
  • Other circumstances judged by investigators that are not suitable for this clinical trial.

Trial locations and contacts

4 sites in 1 country.

Argentina4 sites

  • Fundación Huésped

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1202ABB

  • Vacunar Liniers

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1408FVD

  • Vacunar Cañitas

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426BOF

  • Vacunar Coghlan

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1430BKB

Other trials in Argentina

About this study

Official title: Randomized, Double Blind, Placebo Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Argentine Healthy Population Aged Between 18 and 85 Years

This is a randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old.

Read the detailed description

SARS-CoV-2 belongs to β Coronavirus family and is a pathogen that can spread across races and is easy to cause respiratory diseases.

In December 2019, patients with pneumonia of unknown causes showed fever, cough, dyspnea, accompanied by medical imaging change of patchy diffuse infiltration of the lungs [2]. Through genome sequencing and analysis of lower respiratory tract alveolar lavage fluid samples from patients with pneumonia of unknown cause, a novel coronavirus different from any known virus was found. The World Health Organization WHO named the virus 2019 novel coronavirus, or 2019-nCoV for short, and the disease caused by the virus was named COVID-19. WHO listed the epidemic as a public health emergency of international concern.

With the spread of the SARS-CoV-2 epidemic in the world, vaccines have become the best weapon for epidemic prevention and control. At present, no vaccine to prevent coronavirus disease (COVID-19) in 2019 has been approved for listing. Based on the experience accumulated in the research and development of coronavirus vaccines in the past, the target of vaccines is also mainly focused on S protein.

Inactivated Virus Vaccine inactivates the virus obtained by culture by heating or chemical methods. The inactivated virus loses its pathogenicity and retains the main antigenic characteristics of the virus capsid, which can stimulate the specific immune response of human body. The inactivated SARS-CoV-2 vaccine (Vero cell) is prepared by inoculating African green monkey kidney cells (Vero cell) with the SARS-CoV-2 HB02 strain, culturing, harvesting, inactivating, clarifying, concentrating, purifying, and adding aluminum hydroxide adjuvant. After inoculating the vaccine, the recipients can produce immune response to prevent diseases caused by SARS-CoV-2. The inactivated SARS-CoV-2 vaccine (Vero cell) is prepared by inoculating African green monkey kidney cells (Vero cell) with the SARS-CoV-2 HB02 strain, culturing, harvesting, inactivating, clarifying, concentrating, purifying, and adding aluminum hydroxide adjuvant. After inoculating the vaccine, the recipients can produce immune response to prevent diseases caused by SARS-CoV-2.

Being tested
Inactivated SARS-CoV-2 vaccine (Vero cell), Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine
Keywords
COVID-19, SARS-CoV-2 infection, Inactivated SARS-CoV-2 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.

  • Inactivated SARS-CoV-2 vaccine (Vero cell)Biological

    Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the immunization schedule of Day 0, 21.

  • Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccineBiological

    Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the immunization schedule of Day 0, 21.

Study groups in NCT04560881
Study groupRoleWhat they receive
Inactivated SARS-CoV-2 vaccine, manufactured by BIBPExperimentalIntramuscular injection
Receives: Biological: Inactivated SARS-CoV-2 vaccine (Vero cell)
Placeboof Inactivated SARS-CoV-2 vaccine, manufactured by BIBPPlacebo comparatorIntramuscular injection
Receives: Biological: Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine

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 of vaccination

    All confirmed COVID -19 cases 14 days after the full course of vaccination among healthy population aged between 18 and 85 years old.

    Measured: 14 days after the full course of vaccination

Secondary outcomes (6)

  1. The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    Measured: 14 days after 2-dose of immunization and 28 days after full course of immunization

  2. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    Measured: 14 days after 2-dose of immunization and 28 days after full course of immunization

  3. The Geometric Mean Increase (GMI) of anti-SARS-CoV-2 neutralizing antibody

    Measured: 14 days after 2-dose of immunization and 28 days after full course of immunization

  4. Incidence of any adverse reactions/events

    Measured: Within 30 minutes after each dose of vaccine

  5. Incidence of adverse reactions/events

    Measured: 0 ~ 21/28 days after each dose of vaccine

  6. Incidence of serious adverse events (SAE)

    Measured: From the beginning of the first dose to 12 months after the whole course of immunization

Timeline

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

  1. First posted23 Sep 2020
  2. Study start16 Sep 2020
  3. Primary completion13 Dec 2021
  4. Study completion13 Dec 2021

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
Model description
Clinical trial conducted in randomized, double-blinded, placebo-controlled design.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04560881
Sponsor's protocol ID
BIBP2020003AR
Status last verified
Jan 2022
First submitted
16 Sep 2020
Last updated
12 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inactivated SARS-CoV-2 vaccine (Vero cell) in people with COVID-19 Virus Infection, run by Laboratorio Elea Phoenix S.A. at 4 sites in Argentina.

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 5 inclusion and 18 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 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Argentina. 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 of vaccination (time frame: 14 days after the full course of vaccination). 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 NCT04560881.

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 12 Jan 2022.

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