The Efficacy, Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19

NCT04659239 | Unknown Phase 3 DMC

• 1 other identifier: 20200404
• Study Type: interventional
• Target: 34,020
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a randomized, double-blinded, placebo controlled phase III clinical trial to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after 2-dose schedule.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• The incidence of COVID-19 cases after two-doses of vaccination

  The incidence of the symptomatic and laboratory-confirmed COVID-19 cases starting from Day 14 after the second dose.

  From 14 days after the second dose to 1 year after the second dose.

• The incidence of solicited AEs.

  The incidence of solicited AEs at the inoculation site (local) and solicited AEs at the non-inoculation site (systemic) within 7 days after each dose

  7 days after each dose

Secondary Outcomes (15)

• The incidence of COVID-19 cases after at least one dose of immunization.

  From the first dose to 1 year after the second dose.

• The Geometric Mean Titer (GMT) of neutralizing antibody

  14 days after the whole-course immunization

• The Geometric Mean Titer (GMT) of IgG antibody

  14 days after the whole-course immunization

• The positive rates of neutralizing antibody

  14 days after the whole-course immunization

• The positive rates of IgG antibody

  14 days after the whole-course immunization

Other Outcomes (1)

• The surrogate endpoint of immunogenicity

  From 14 days after the second dose to 1 year after the second dose.

Study Arms (2)

Investigational Vaccine

EXPERIMENTAL

Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) according to the immunization schedule of D0, D14.

Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)

Placebo

PLACEBO COMPARATOR

Participants will receive 2 doses of the placebo according to the immunization schedule of D0, D14.

Biological: Placebo

Interventions

Inactivated SARS-CoV-2 Vaccine (Vero cell) BIOLOGICAL

The inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.

Investigational Vaccine

Placebo BIOLOGICAL

The placebo was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.

Placebo

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years and above (including boundary values), both female and male.
• Legal identification of the participants shall be provided.
• Participants shall understand the content in the Informed Consent Form (ICF) and the vaccine for administration, sign the ICF voluntarily and are capable of using thermometers and rulers, and filling in diary cards and contact cards as per the requirements.
• Subject shall be able to communicate well with investigators, understand and comply with the requirements of this study.
• Participants with oral temperature ≤ 37.9 ℃.
• Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile \[i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months\]) must agree to be heterosexually inactive OR consistently use any of the following methods of contraception:
• Condoms (male or female)
• Diaphragm with spermicide
• Cervical cap with spermicide
• Intrauterine device
• Oral or patch contraceptives
• Any country regulatory-approved contraceptive method that is designed to protect against pregnancy
• Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle (other approaches to abstinence are not acceptable).

You may not qualify if:

• Contraindications to commonly used vaccines;
• History of allergy to any vaccines or drug;
• Received any vaccine within 1 month before the first dose of vaccination；
• Serious diseases required to be excluded, including but not limited to history of diseases in nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other systems, and a history of malignant tumors;
• Before immunizing the first dose of investigational vaccine, those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days;
• Those who have a hereditary bleeding tendency or blood coagulation dysfunction, or a history of thrombosis or hemorrhagic disease；
• Surgical removal of whole or part of spleen for any reason；
• Those who have undergone surgery within 3 months before signing the ICF or those who plan to undergo surgery during or within 3 months after completion of the trial (including plastic surgery, dental and oral surgery);
• Those who donated or lost blood (≥400 mL) in the past 3 months, who received blood transfusion or use of blood products, or who plan blood donation during the trial;
• Those who received other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months before signing the ICF, or plan to use them during the study.
• Those who received immunosuppressant therapy within 6 months before signing the ICF, such as long-term systemic glucocorticoid treatment (with systemic glucocorticoid therapy for more than 2 consecutive weeks within 6 months, such as prednisone or similar drugs), but local administration is permitted (such as ointment, eye drops, inhalants, or nasal spray). The local administration should not exceed the recommended dose in the package insert or have any signs of systemic exposure;
• Participants cannot meet the criteria through the comprehensive physical examination, mainly including:
• Abnormal vital signs with clinical significance (awakening heart rate \<55 beats/min or \>100 beats/min, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
• Those who tested positive for type 1 or type 2 human immunodeficiency virus (HIV-1/2) antibody, or SARS-CoV-2 nucleic acid;
• History of COVID-19;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (2)

CEMEC Pesquisa Clinica

São Bernardo do Campo, São Paulo, Brazil

Location

Hospital Sungai Buloh

Sungai Buloh, Selangor, 47000, Malaysia

Location

MeSH Terms

Conditions

COVID-19

Interventions

SARS-CoV-2 inactivated vaccines

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

• Yasmin binti Mohamed Gani, PhD

  Hospital Sungai Buloh

  PRINCIPAL INVESTIGATOR

• Adilson JW Cavalcante, PhD

  CEMEC Pesquisa Clinica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 9, 2020
• Study Start: January 28, 2021
• Primary Completion: September 1, 2021
• Study Completion: July 1, 2022
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

BR (1); MY (1)