COVID-19 trials registries data warehouse

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=051-20

German Javier Malaga

german.malaga@upch.pe

2020-08-18

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

- 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.

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 &#8451,), 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 &#8451, 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 &#8805, 140 mmHg, diastolic blood pressure &#8805, 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 &#8805, 39.0 &#8451,) 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.

3

UNIVERSIDAD PERUANA CAYETANO HEREDIA;

18

100

Peru

Healthy volunteers

N/A

12000

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.

Phase 3

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