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

NCT04612972 | Completed Phase 3 DMC

• 1 other identifier: UPeruanaCH
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Proportion of confirmed Covid-19 cases in the two vaccine groups and the placebo group.

  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.

  One year beginning on day 14 after the second dose of immunization

Secondary Outcomes (2)

• Proportion of severe cases of SARS CoV 2 pneumonia and deaths in the two vaccine groups and the placebo group.

  One year beginning on day 14 after the second dose of immunization

• Incidence of any adverse reactions/events

  12 months

Other Outcomes (4)

• Comparison of levels of neutralizing antibodies in infected versus non infected participants

  After 14 days after 2 doses of immunization

• Number of ADE/VED cases

  28days after full course of immunization.

• 4-fold growth rate, GMT and GMI of anti-SARS-CoV-2 neutralizing antibody at day 28

  28days after full course of immunization.

Study Arms (3)

Investigational vaccine 1. Wuhan

EXPERIMENTAL

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

Investigational vaccine 2. Beijing

EXPERIMENTAL

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

Placebo/Aluminum Adjuvant of Inactivated SARS CoV

PLACEBO COMPARATOR

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

Interventions

Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan/Beijing/Placebo BIOLOGICAL

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.

Investigational vaccine 1. Wuhan; Investigational vaccine 2. Beijing; Placebo/Aluminum Adjuvant of Inactivated SARS CoV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• National University of San Marcos, Peru: collaborator

Study Sites (1)

Av. Honorio Delgado 430, Urb. Ingeniería

San Martín de Porres, Lima region, L-031, Peru

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Coralith Garcia, MD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers and participants are masked to Intervention group. Individual syringes are coded with a consecutive number only
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: November 3, 2020
• Study Start: September 9, 2020
• Primary Completion: February 19, 2021
• Study Completion: April 3, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

PE (1)