None listed
Conditions
Interventions
Investigational vaccine 1: Type of group
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)
Group name:Placebo Type of group
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
Sponsors
UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Eligibility
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Incidence of COVID-19 cases after two doses of vaccination through active follow-up of subjects. Measure:Protective effect of the inactivated SARS-CoV-2 vaccine (Vero cell) Timepoints:From 14 days after the second dose to 12 months after the second dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Incidence of adverse events Measure:Safety of immunization of 2 doses of the inactivated SARSCoV- 2 vaccine Timepoints:From the start of the first dose until 12 months after the second immunization ; Outcome name:Incidence of reports of severe SARS-CoV-2 pneumonia cases and deaths. Measure:Protective effect of immunization after 2 doses of the inactivated SARS-CoV-2 vaccine against severe COVID- 19 and deaths associated with COVID-19. Timepoints:From 14 days after the second dose to 12 months after the second dose ; Outcome name:The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody, GMT and GMI from anti-SARSCoV- 2. Measure:Immunogenicity of the 2-dose immunization of the inactivated SARS-CoV-2 vaccine Timepoints:14 days after the complete immunization cycle | — |
Countries
Peru
Contacts
Public ContactGerman Javier Malaga
UNIVERSIDAD PERUANA CAYETANO HEREDIA
Outcome results
None listed