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

COVID-19 Clinical Trial

— COVID-19  

Official title:

A Randomized, Double-Blinded, Cohort Clinical Study on Evaluating the Safety and Immunogenicity of Sequential Immunization of Two Doses of BIBP Inactivated COVID-19 Vaccine (Omicron), WIBP Inactivated COVID-19 Vaccine (Omicron) or Inactivated COVID-19 Vaccine (Prototype) in Population Aged 18 Years and Above Who Have Completed Two or Three Doses of Inactivated or mRNA Vaccine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05382871
• Other study ID #: CNBG-O-2022002
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 27, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: China National Biotec Group Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1804
• Est. completion date: March 31, 2024
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.
• Female participants who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 7 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
intramuscular injection in the deltoid muscle
• WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
intramuscular injection in the deltoid muscle
• COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (4)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Beijing Institute of Biological Products Co Ltd., The University of Hong Kong, Wuhan Institute of Biological Products Co., Ltd

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of COVID-19 cases , including severe cases and deaths accompanied by COVID-19		From 14 day after vaccination
Primary	The Geometric Mean Titer (GMT) of anti-omicron neutralizing antibody		28 days after sequential vaccination of 2 doses
Primary	The 4-fold rise rate of anti-omicron neutralizing antibody		28 days after sequential vaccination of 2 doses
Secondary	The GMT of anti-omicron neutralizing antibody		14 days after sequential vaccination of 2 doses
Secondary	The 4-fold rise rate of anti-omicron neutralizing antibody		14 days after sequential vaccination of 2 doses
Secondary	Specific cellular immune response		within 28 days after vaccination
Secondary	The GMT of anti-omicron Immunoglobulin G (IgG) antibody		28 days after sequential vaccination of 2 doses
Secondary	The proportions of neutralizing antibody titer = 1: 16, = 1: 32 and = 1: 64		28 days after sequential vaccination of 2 doses
Secondary	The proportion of subjects with neutralizing antibody GMT =1:16,=1:32 and =1:64		on 3rd month, 6th month, 9th month, and 12th month after vaccination
Secondary	The incidence of any adverse reactions/events		28 days after each immunization
Secondary	The incidence of serious adverse events (SAE) and adverse events special interest (AESI)		from 1st booster dose and up to 6 months following 2nd booster dose