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Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru (Covid-Peru)

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ClinicalTrials.gov Identifier: NCT04612972
Recruitment Status : Active, not recruiting
First Posted : November 3, 2020
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
National University of San Marcos, Peru
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Brief Summary:
This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan/Beijing/Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Arm 1:Investigational vaccine 1:

Inactivated SARS-CoV-2 vaccine (Vero cell) Manufacturer: Wuhan Institute of Biological Products Co., Ltd. Wuhan Institute of Virology, Chinese Academy of Sciences Specification: 200WU/dose for per human use, 0.5 mL/ dose

Arm 2: Investigational vaccine 2:

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

Arm 3: Placebo 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

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Researchers and participants are masked to Intervention group. Individual syringes are coded with a consecutive number only
Primary Purpose: Prevention
Official Title: Ensayo Clínico de Fase III, Aleatorio, Doble Ciego y Controlado Con Placebo Paralelo, Para Evaluar la Seguridad y la Eficacia Protectora de la Vacuna Inactivada Contra el SARS-CoV-2 en la Población Sana de 18 años o más, en Perú
Actual Study Start Date : September 9, 2020
Actual Primary Completion Date : February 19, 2021
Estimated Study Completion Date : December 19, 2021

Arm Intervention/treatment
Experimental: Investigational vaccine 1. Wuhan
Inactivated SARS-CoV-2 vaccine (Vero cell); 200WU/dose for per human use, 0.5 mL/ dose; Intramuscular injection; Two doses: one dose/21-28 days; 4000 participants per arm
Biological: Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan/Beijing/Placebo
This clinical trial is conducted in randomized, blind, placebo controlled design Total sample size is 12 000, which are randomly allocated into investigational vaccine 1, investigational vaccine 2 and placebo control group.

Experimental: Investigational vaccine 2. Beijing
Inactivated SARS-CoV-2 vaccine (Vero cell); 4μg/dose for per human use, 0.5 mL/ dose; Intramuscular injection; Two doses: one dose/21-28 days; 4000 participants per arm
Biological: Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan/Beijing/Placebo
This clinical trial is conducted in randomized, blind, placebo controlled design Total sample size is 12 000, which are randomly allocated into investigational vaccine 1, investigational vaccine 2 and placebo control group.

Placebo Comparator: Placebo/Aluminum Adjuvant of Inactivated SARS CoV
Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine; Active Ingredient: None; Virus Contents: None; Adjuvant: aluminum hydroxide; Specification: 0.5 mL/ dose, 0.5mL for per human use; Intramuscular injection; Two doses: one dose/21-28 days; 4000 participants per arm
Biological: Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan/Beijing/Placebo
This clinical trial is conducted in randomized, blind, placebo controlled design Total sample size is 12 000, which are randomly allocated into investigational vaccine 1, investigational vaccine 2 and placebo control group.




Primary Outcome Measures :
  1. Proportion of confirmed Covid-19 cases in the two vaccine groups and the placebo group. [ Time Frame: One year beginning on day 14 after the second dose of immunization ]
    Protective effect against COVID 19, after 14 days following the full course of vaccination among healthy population aged 18 years old and above. Comparison of the proportions of confirmed Covid-19 cases in the two vaccine groups and the placebo group. All confirmed cases are all confirmed by DSMB blind examination.


Secondary Outcome Measures :
  1. Proportion of severe cases of SARS CoV 2 pneumonia and deaths in the two vaccine groups and the placebo group. [ Time Frame: One year beginning on day 14 after the second dose of immunization ]
    To evaluate the protective effect after 14 days following 2 doses of immunization of preventing severe cases of SARS CoV 2 pneumonia and deaths caused by COVID 19, among healthy population aged 18 years old and above. Comparison of the proportions of severe cases of SARS CoV 2 pneumonia and deaths in the two vaccine groups and the placebo group.

  2. Incidence of any adverse reactions/events [ Time Frame: 12 months ]
    Observe the incidence of any adverse reactions/events within 30 minutes after each dose of vaccine Observe the incidence of adverse reactions/events at 0 ~ 7 days and 8 ~ 21/30 days after each dose of vaccine. Observe the incidence of serious adverse events (SAE) from the beginning of the first dose to 12 months after the whole course of immunization.


Other Outcome Measures:
  1. Comparison of levels of neutralizing antibodies in infected versus non infected participants [ Time Frame: After 14 days after 2 doses of immunization ]
    To explore the protective level of anti-SARS-CoV-2 neutralizing antibody against diseases caused by SARS-CoV-2 infection.

  2. Number of ADE/VED cases [ Time Frame: 28days after full course of immunization. ]
    The occurrence of ADE/VED after immunization.

  3. 4-fold growth rate, GMT and GMI of anti-SARS-CoV-2 neutralizing antibody at day 28 [ Time Frame: 28days after full course of immunization. ]
    To evaluate the 4-fold growth rate, GMT and GMI of anti-SARS-CoV-2 neutralizing antibody 28days after full course of immunization.

  4. GMT of anti-SARS-CoV-2 neutralizing antibody at 6 and 12 months [ Time Frame: 6th month and 12th month after 2 doses of immunization. ]
    The GMT of anti-SARS-CoV-2 neutralizing antibody in 6th month and 12th month after 2 doses of immunization.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 month s 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:

  • 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. - Hist ory 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
  • Live attenuated va ccine 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 vacc ination
  • Investigator judged other circumstances 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): NCT04612972


Locations
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Peru
Av. Honorio Delgado 430, Urb. Ingeniería
San Martin De Porres, Lima, Peru, L-031
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
National University of San Marcos, Peru
Investigators
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Principal Investigator: Coralith Garcia, MD Universidad Peruana Cayetano Heredia
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Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT04612972    
Other Study ID Numbers: UPeruanaCH
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases