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

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ClinicalTrials.gov Identifier: NCT04560881
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
Beijing Institute of Biological Products Co., Ltd
China National Biotec Group Company Limited
The Huesped Foundation
Information provided by (Responsible Party):
Laboratorio Elea Phoenix S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Virus Infection Biological: Inactivated SARS-CoV-2 vaccine (Vero cell) Biological: Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical trial conducted in randomized, double-blinded, placebo-controlled design.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : September 16, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: Inactivated SARS-CoV-2 vaccine, manufactured by BIBP
Intramuscular injection
Biological: Inactivated SARS-CoV-2 vaccine (Vero cell)
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 Comparator: Placeboof Inactivated SARS-CoV-2 vaccine, manufactured by BIBP
Intramuscular injection
Biological: Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine
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.




Primary Outcome Measures :
  1. Incidence of COVID-19 cases after two-doses of vaccination [ Time Frame: 14 days after the full course 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.


Secondary Outcome Measures :
  1. The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 14 days after 2-dose of immunization and 28 days after full course of immunization ]
  4. Incidence of any adverse reactions/events [ Time Frame: Within 30 minutes after each dose of vaccine ]
  5. Incidence of adverse reactions/events [ Time Frame: 0 ~ 21/28 days after each dose of vaccine ]
  6. Incidence of serious adverse events (SAE) [ Time Frame: From the beginning of the first dose to 12 months after the whole course of immunization ]

Other Outcome Measures:
  1. Anti-SARS-CoV-2 neutralizing antobody (NtAb) (immunological surrogate endpoint) [ Time Frame: 14 days after 2-dose of immunization. ]
    The protective level of Anti-SARS-CoV-2 NtAbs



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 to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

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): NCT04560881


Contacts
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Contact: Pedro Cahn, MD +54 11 49817777 pedro.cahn@huesped.org.ar
Contact: Eduardo Spitzer, B.Sc. +54 11 44898300 trials@elea.com

Locations
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Argentina
Fundación Huésped Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1202ABB
Contact: Maria I Figueroa, MD    +5411 4981 7777    maria.figueroa@huesped.org.ar   
Principal Investigator: Pedro Cahn, MD         
Vacunar Liniers Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1408FVD
Contact: Gabriela Aguirre, MSc    08004448228    gabyaguirre@vacunar.com.ar   
Principal Investigator: Ricardo Ruttimann, MD         
Vacunar Cañitas Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426BOF
Contact: Gabriela Aguirre, MSc    08004448228    gabyaguirre@vacunar.com.ar   
Principal Investigator: Florencia Cahn, MD         
Vacunar Coghlan Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1430BKB
Contact: Gabriela Aguirre, MSc    08104448228    gabyaguirre@vacunar.com.ar   
Principal Investigator: Pablo Bonvehi, MD         
Sponsors and Collaborators
Laboratorio Elea Phoenix S.A.
Beijing Institute of Biological Products Co., Ltd
China National Biotec Group Company Limited
The Huesped Foundation
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Responsible Party: Laboratorio Elea Phoenix S.A.
ClinicalTrials.gov Identifier: NCT04560881    
Other Study ID Numbers: BIBP2020003AR
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorio Elea Phoenix S.A.:
COVID-19
SARS-CoV-2 infection
Inactivated SARS-CoV-2 Vaccine
Additional relevant MeSH terms:
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Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs