Sequential Immunization of Two Doses of Inactivated COVID-19 Vaccine (Omicron) in Vaccinated Population Aged 18 Years and Above

NCT05382871 | Unknown Phase 3

• 1 other identifier: CNBG-O-2022002
• Study Type: interventional
• Target: 1,804
• Locations: 1 country
• Sites: 1

Brief Summary

This trial adopts a randomized, double-blind and positive control design, it is planned to recruit 1800 healthy participants who have been vaccinated with 2/3 doses of COVID-19 inactivated vaccine or mRNA vaccine for 3 months. The participants will be divided into two strata according to the types of vaccines administered, including 900 participants of COVID-19 inactivated vaccine and 900 participants of mRNA vaccine. According to the ratio of 1:1:1, each stratum was randomly assigned to three groups: sequential BIBP- COVID-19 inactivated vaccine (Omicron), WIBP-COVID-19 inactivated vaccine (Omicron) or COVID-19 inactivated vaccine (prototype strain). And according to D0, D28 immunization schedule, two doses of corresponding group vaccines are sequentially administered.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• The Geometric Mean Titer （GMT） of anti-omicron neutralizing antibody

  28 days after sequential vaccination of 2 doses

• The 4-fold rise rate of anti-omicron neutralizing antibody

  28 days after sequential vaccination of 2 doses

Secondary Outcomes (8)

• The GMT of anti-omicron neutralizing antibody

  14 days after sequential vaccination of 2 doses

• The 4-fold rise rate of anti-omicron neutralizing antibody

  14 days after sequential vaccination of 2 doses

• Specific cellular immune response

  within 28 days after vaccination

• The GMT of anti-omicron Immunoglobulin G (IgG) antibody

  28 days after sequential vaccination of 2 doses

• The proportions of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64

  28 days after sequential vaccination of 2 doses

Other Outcomes (1)

• The incidence of COVID-19 cases , including severe cases and deaths accompanied by COVID-19

  From 14 day after vaccination

Study Arms (6)

1: BIBP Inactivated COVID-19 vaccine (Omicron)

EXPERIMENTAL

subjects will be blinded and receive two doses of BIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine

Biological: BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)

2: WIBP Inactivated COVID-19 vaccine (Omicron)

EXPERIMENTAL

subjects will be blinded and receive two doses of WIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine

Biological: WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)

3：BIBP Inactivated COVID-19 vaccine (Omicron)

EXPERIMENTAL

subjects will be blinded and receive two doses of BIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine

Biological: BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)

4: WIBP Inactivated COVID-19 vaccine (Omicron)

EXPERIMENTAL

subjects will be blinded and receive two doses of WIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine

Biological: WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)

5：Inactivated COVID-19 Vaccine (prototype)

ACTIVE COMPARATOR

subjects will be blinded and receive two doses of Inactivated COVID-19 Vaccine (prototype) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

6：Inactivated COVID-19 Vaccine (prototype)

ACTIVE COMPARATOR

subjects will be blinded and receive two doses of Inactivated COVID-19 Vaccine (prototype) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

Interventions

BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell) BIOLOGICAL

intramuscular injection in the deltoid muscle

1: BIBP Inactivated COVID-19 vaccine (Omicron); 3：BIBP Inactivated COVID-19 vaccine (Omicron)

WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell) BIOLOGICAL

intramuscular injection in the deltoid muscle

2: WIBP Inactivated COVID-19 vaccine (Omicron); 4: WIBP Inactivated COVID-19 vaccine (Omicron)

COVID-19 Vaccine (Vero Cell), Inactivated BIOLOGICAL

intramuscular injection in the deltoid muscle

5：Inactivated COVID-19 Vaccine (prototype); 6：Inactivated COVID-19 Vaccine (prototype)

Eligibility Criteria

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

You may qualify if:

• Age range: populations aged 18 years and above.
• Judged by the investigator that the health condition is well after inquiry and physical examination.
• Vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine or mRNA vaccine for ≥ 3 months.
• 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 study procedures, the informed consent \& voluntarily sign an informed consent form and is able to comply with the requirements of the clinical study protocol.

You may not qualify if:

• Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
• With a history of Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) (self-report, on-site inquiry);
• Has vaccinated with one or four doses and above COVID-19 vaccine;
• Axillary temperature ≥37.3℃ (Tympanic temperature ≥ 37.6 ℃);
• Previous allergic reactions to drug or vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of COVID-19 vaccine (self-report, onsite enquiry);
• Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders (self-report, onsite enquiry);
• With known immunological impairment or immunocompromised diagnosed by the hospital (self-report, onsite enquiry);
• Have an uncontrolled epilepsy and other progressive neurological diseases or a history of Guillain-Barre syndrome (self-report, onsite enquiry);
• Received whole blood, plasma and immunoglobulin therapy within 1 month (self-report, onsite enquiry);
• Known or suspected severe illness includes: respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumor, infectious or allergic skin disease, Human Immunodeficiency Virus (HIV) infection (self-report, onsite enquiry, provide test report if available);
• With hospital-diagnosed serious cardiovascular diseases (cardiopulmonary failure, drug-uncontrolled hypertension (physical examination of systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg), acute attacks of chronic respiratory illness (self-report, onsite enquiry);
• Received live attenuated vaccines within 1 month before vaccination (self-report, onsite enquiry);
• Received inactivated vaccines within 14 days before vaccination (self-report, onsite enquiry);
• Participating or planning to participate in other interventional vaccine clinical trials during this study
• Other vaccination-related contraindications considered by investigators.

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Beijing Institute of Biological Products Co Ltd.: collaborator
• Wuhan Institute of Biological Products Co., Ltd: collaborator
• The University of Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ivan Hung, Clinical Professor

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 19, 2022
• Study Start: May 27, 2022
• Primary Completion: July 27, 2023
• Study Completion: March 31, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)