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DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-051-20
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: UNIVERSIDAD PERUANA CAYETANO HEREDIA   Type of Organization / Institution : Universidad 
Legal Domicile : Av. Honorio Delgado 430 
District: San Martin de Porres  Province: Lima 
Departament: Lima 
Single Taxpayer No : 20110768151 
Telephone: 3190000   Fax:  
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
RANDOMIZED, DOUBLE BLIND, PARALLEL PLACEBO CONTROLLED, PHASE III CLINICAL TRIAL TO EVALUATE THE SAFETY AND PROTECTIVE EFFICACY OF INACTIVATED SARS-COV-2 VACCINE IN HEALTHY POPULATION AGED 18 YEARS AND ABOVE


Public Title
INACTIVATED SARS-COV-2 VACCINE (VERO CELL) PHASE III CLINICAL STUDY PROTOCOL


Clinical Trial Registration Date Most recent Clinical Trial Update
18/08/2020  
Principal Sponsor :
1.- UNIVERSIDAD PERUANA CAYETANO HEREDIA  
Secondary Sponsor :
 
Funding Source
1.-  CHINA NATIONAL BIOTEC GROUP COMPANY LIMITED
Executing Company / Institution / Other
- UNIVERSIDAD PERUANA CAYETANO HEREDIA Authorized with   306-2020-OGITT-INS Date 18/08/2020
Responsabilities
 
  Others
UNIVERSIDAD PERUANA CAYETANO HEREDIA  
  Inform to the OGITT of the NIH when the first subject is enrolled in Peru, and the end date of enrollment in the country.
  Submit progress reports to the National Health Institute during the execution of the Clinical Trial.
  Submit to the OGITT of the NIH the final reports as well as the results, conclusions, and publication of the clinical trial
  Notify to the OGITT of the NIH the adverse events and deviations as established in the Clinical Trials Regulation.
  Inform and describe the reasons for a suspension and cancellation of the clinical trial.
  Provide the facilities for the inspection of the execution of the clinical trial by the staff of the General Office of Research and Technology Transfer (OGITT) of the National Institute of Health.
Study clinical phase: III  Protocol Code SIDIDI203150 
Secondary ID(s) :  
WHO UTN: NA
CLINICALTRIALS.GOV: NA
EUDRACT N°:NA
Study Design
This clinical trial is conducted in randomized, blind, placebo-controlled design. Total sample size is 6,000, which are randomly allocated into investigational vaccine 1, investigational vaccine 2 and placebo control group.  
Insurance policy due date 31/08/2021  Assignation method Randomized 
Non randomized 
Type of blinding Assignation
Simple  Double  Triple 
Open
Single arm        Parallel
Crossed                 Factorial
Others:
Purpose
To evaluate the protective efficacy of inactivated SARS-CoV-2 Vaccine (Vero Cell) after full course of immunization in preventing diseases caused by the SARS-CoV-2 in healthy subjects aged 18 years old and above.  
Research Product Information
Name of the product Generic Name Type of product ATC
INACTIVATED SARS-COV-2 VACCINE (VERO CELL) BEIJING INSTITUTE OF BIOLOGICAL PRODUCTS Inactivated SARS-CoV-2 Vaccine (Vero Cell)       J07
INACTIVATED SARS-COV-2 VACCINE (VERO CELL) WUHAN INSTITUTE OF BIOLOGICAL PRODUCTS Inactivated SARS-CoV-2 Vaccine (Vero Cell)       J07
Name of the compare Generic Name Type of product ATC
PLACEBO/ALUMINUM ADJUVANT OF INACTIVATED SARS-COV-2 VACCINE Hidróxido de aluminio      A02
Intervention(s) description:
Group name Type of group N° of participants Intervention(s) description
Investigational vaccine 1: Experimental
Control
4000   Inactivated SARS-CoV-2 vaccine (Vero cell) Manufacturer: Wuhan Institute of Biological Products Co., Ltd. Specification: 200WU/dose for per human use, 0.5 mL/ dose solution for parenteral injection, intramuscular, 0.5 ml/dose, two doses (Day 0, day 21-28)
Investigational vaccine 2: Experimental
Control
4000   Inactivated SARS-CoV-2 vaccine (Vero cell) Manufacturer: Beijing Institute of Biological Products Co., Ltd. Specification: 4μg/dose for per human use, 0.5 mL/ dose solution for parenteral injection, intramuscular, 0.5 ml/dose, two doses (Day 0, day 21-28)
Placebo Experimental
Control
4000   Product name: Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine Active Ingredient: None; Virus Contents: None Adjuvant: aluminum hydroxide Manufacturer: Wuhan Institute of Biological Products Co., Ltd. Specification: 0.5 mL/ dose, 0.5mL for per human use, two doses (day 0, day 21-28) Solution for parenteral injection (intramuscular)
Inclusion Criteria
- Age range: Healthy subjects aged 18 years old and above - 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 do not plan to become pregnant within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion and continued for at least three months after last dose. - 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 research procedures, with informed consent, voluntarily sign an informed consent form, and be able to comply with the requirements of the clinical study protocol.  
Exclusion Criteria
First dose exclusion criteria - SARS-CoV-2 Infection Confirmed Cases, Suspected Cases or Asymptomatic Infection - SARS-CoV-2 Nucleic acid test positive - Have a history of SARS, MERS infection (self-report, on-site inquiry) - 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. - Axillary body temperature > 37.0 ℃ before vaccination - 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. - Have a history of convulsion, epilepsy, encephalopathy or mental illness or family history. - Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. - 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. - Diseases known or suspected include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors. - 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) - Live attenuated vaccine is inoculated 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. - Investigator judged other circumstances that are not suitable for this clinical trial. Second dose exclusion criteria - Patients with high fever (axillary temperature ≥ 39.0 ℃) lasting for 3 days after the previous dose of vaccine and severe allergic reaction; - Serious adverse reactions with causal relationship with the previous dose of vaccine; - Reach the endpoint of a study; - for the subjects newly identified or newly co-curred which does not meet the inclusion criteria for the first dose or meets the exclusion criteria for the first dose after the previous dose of vaccine is vaccinated, the investigator shall determine whether they should continue to participate in the trial; - Other reasons for exclusion that investigator believes. If any of the following occurs during the trial, the relevant subjects are not required to stop the trial. - Non-specific immunoglobulins were used during the study. - Continuous oral or IV administration of steroid hormones for 14 days.  
Worldwide enrolment start date 15/09/2020 
Enrolment start date in Peru (Initial) 15/09/2020  Enrolment start date in Peru 09/09/2020 
Peru enrolment status Without starting enrollment
Enrollment stopped
  In enrollment
  Enrollment closed 
Clinical Trial Total Duration 16  months Medical Speciality INTERNAL MEDICINE 
Studied Condition (CIE-10 code) -B342 Coronavirus infection, unspecified site  
Number of subjects to be included in all the countries 6000 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
12000 12000
Countries where the enrolment is conducted :
- Peru
Number of participants per gender (Initial) Female: 0 
Male : 0 
Number of participants per gender (Posterior) Female: 0 
Male : 0
Range of age of subjects to be included : - Adults (18-64 years) Yes   No
- Elderly (>= 65 years) Yes   No
- Under 18 years Yes   No
  If yes, specify:
  - In Utero Yes  No
  - Preterm newborn infants (up to gestational age < 37 weeks) Yes  No
  - Newborns (0-27 días) Yes  No
  - Infants and toddlers (28 days-23 months) Yes  No
  - Children (2 - 11 years) Yes  No
  - Adolescents (12 - 17 years) Yes  No
Subjects' treatment time 28  day(s) Subjects' follow up time 12  month(s)
Primary Outcome  
Name of the outcome Metric or method of measurement Time point for the outcome
Protective effect of the inactivated SARS-CoV-2 vaccine (Vero cell) Incidence of COVID-19 cases after two doses of vaccination through active follow-up of subjects. From 14 days after the second dose to 12 months after the second dose. 
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
Safety of immunization of 2 doses of the inactivated SARSCoV- 2 vaccine Incidence of adverse events From the start of the first dose until 12 months after the second immunization 
Protective effect of immunization after 2 doses of the inactivated SARS-CoV-2 vaccine against severe COVID- 19 and deaths associated with COVID-19. Incidence of reports of severe SARS-CoV-2 pneumonia cases and deaths. From 14 days after the second dose to 12 months after the second dose 
Immunogenicity of the 2-dose immunization of the inactivated SARS-CoV-2 vaccine The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody, GMT and GMI from anti-SARSCoV- 2. 14 days after the complete immunization cycle 
3. RESEARCH SITE, PRINCIPAL INVESTIGATOR, ETHICS COMMITTEE
Research site where the clinical trial will be conducted Principal Investigator Institutional Research Ethics Committee (CIEI) that approved the trial for the site Observations
Research Institution RCI Research site Full name RCEI Ethics Committe Name Status Approval date End approval date Term Telephone number Email addrees
UNIVERSIDAD PERUANA CAYETANO HEREDIA RCI 33 CENTRO DE ESTUDIOS CLÍNICOS - UPCH
El registro esta inactivo para nuevos EC
GERMAN JAVIER MALAGA RODRÌGUEZ

Cambio de Investigador por :
- CORALITH MARLINDA GARCIA APAC (Resolución Directoral 145-2021-OGITT-INS del 03/03/2021)
- SERGIO ELI RECUENCO CABRERA (Resolución Directoral 175-2021-OGITT-INS del 09/04/2021)
RCEI-305 COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 - CNTEIApproved 31/08/2020 31/08/2021127126450  
Co-Investigator
- Javier Arturo Bustos Palomino
- Hector Hugo Garcia Lescano
 
SERVICIOS MÉDICOS UNMSM RCI-34 UNIDAD DE ENSAYOS CLÍNICOS DE LA UNIVERSIDAD NACIONAL MAYOR DE SAN MARCOS
El registro esta inactivo para nuevos EC
EDUARDO ROMULO TICONA CHAVEZ


RCEI-305  COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 - CNTEI Approved 25/09/2020  18/08/2021    - Research Site Extension R.D. 407-2020-OGITT-INS with date 26/09/2020  
Co-Investigator
 
COMPLETION DATE:
4. IPD SHARING STATEMENT
Is there a plan for sharing of deidentified individual clinical trial participant-level data (IPD) to other researchers (including data dictionaries)?
Yes   No Non decided
In case the answer is affirmative, describe the Plan.
 
Additional information that will be shared. Study protocol
Statistical Analysis Plan
Informed Consent Form
Clinical Study report
Others: ________________
Describe briefly when this information will be available and how it can be obtained
 
URL www.cayetano.edu.pe
5. CLINICAL TRIAL CONTACT PERSONS INFORMATION
Full Name E-mail Telephone Type of queries to be resolved
Information to general public Administrative Consultations Scientific Consultations
Germán Javier Málaga Rodriguez german.malaga@upch.pe 992768300 Yes Yes
Juan Manuel Miyahira Arakaki juan.miyahira@upch.pe 3190000 Yes
Mónica Cecilia Vera Cabanillas monica.vera.c@upch.pe 990352994 Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  306-2020-OGITT-INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 18/08/2020  (Validity date from:18/08/2020)
SUMMARY EVALUATION REPORT
APPROVED PROCEDURES
TYPE OF PROCEDURE TYPE AND NUMBER OF RESOLUTION / OFFICIAL LETTER DATE OF RESOLUTION / OFFICIAL LETTER VALIDITY DATE ANNULATION
FROM

TO

 

Extension / Modification of Supply List
R.D. 332-2020-OGITT-INS
26/08/2020

Clinical Trial Amendment Report
 946-2020-OGITT-INS
08/09/2020

Research Site Extension
R.D. 407-2020-OGITT-INS
26/09/2020

Clinical Trial Amendment Report
 1192-2020-OGITT-INS
09/10/2020

Clinical Trial Amendment Report
 1218-2020-OGITT-INS
16/10/2020

Clinical Trial Amendment Report
 1343-2020-OGITT-INS
03/11/2020

Clinical Trial Amendment Report
 1373-2020-OGITT-INS
07/11/2020

Clinical Trial Progress Report
 
27/11/2020 11:04:40 a.m.

Clinical Trial Progress Report
 
27/11/2020 11:05:06 a.m.

Clinical Trial Amendment Report
 1598-2020-OGITT/INS
16/12/2020

Clinical Trial Amendment Report
 140-2021-OGITT/INS
26/01/2021

Change of Clinical Trial Principal Investigator
R.D. 145-2021-OGITT-INS
03/03/2021

Clinical Trial Progress Report
R.D. 
16/03/2021 11:36:23 a.m.

Clinical Trial Progress Report
R.D. 
16/03/2021 11:42:50 a.m.

Change of Clinical Trial Principal Investigator
R.D. 175-2021-OGITT-INS
09/04/2021

Clinical Trial Amendment Report
 1013-2021-OGITT-INS
03/05/2021
03/05/2021

Extension / Modification of Supply List
R.D. 203-2021-OGITT-INS
04/05/2021

Extension / Modification of Supply List
R.D. 208-2021-OGITT/INS
12/05/2021

Clinical Trial Progress Report
R.D. 
07/06/2021 12:57:36 p.m.

Clinical Trial Progress Report
R.D. 
07/06/2021 12:57:49 p.m.

Clinical Trial Amendment Report
 1299-2021-OGITT-INS
14/06/2021

Clinical Trial Amendment Report
 1297-2021-OGITT/INS
14/06/2021

Clinical Trial Progress Report
 
06/09/2021 11:51:49 p.m.

Clinical Trial Progress Report
 
06/09/2021 11:54:17 p.m.