Status unknownNCT05033847Updated Feb 2, 2023

Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above

A Phase 2 interventional study of Recombinant COVID-19 Vaccine (CHO cell) and COVID-19 vaccine (Vero cells) in COVID-19 Pneumonia and Coronavirus Infections, sponsored by National Vaccine and Serum Institute, China. Status unknown at 1 site in United Arab Emirates. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.

Sponsored by National Vaccine and Serum Institute, China · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 1,800
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is randomized, blinded and controlled design. Among the randomly selected subjects who have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell), based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19 vaccine sequentially at different shedules of 1-3 months, 3-6 months and ≥ 6 months after two doses of vaccination, and the subjects vaccinated at different schedules will be randomly assigned to different sequential immunization groups. At the same time, each sequential immunization group will be matched with a control group with the inactivated COVID-19 vaccine (vero cells) as the booster dose.

Conditions studied

COVID-19 Pneumonia
Coronavirus Infections

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Keywords

COVID-19

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,800 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

National Vaccine and Serum Institute, China is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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 of CNBG inactivated COVID-19 vaccine according to the product insert;
Female subjects who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 6 months after enrolment. 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; Self has 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

Exclusion Criteria:

Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
With a history of SARS and MERS infection (self-report, on-site inquiry);
Has vaccinated with any vaccine other than one or more doses of CNBG inactivated COVID-19 vaccine;
Axillary temperature ≥ 37.3 ℃ (forehead temperature ≥ 37.8 ℃);
Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of recombinant COVID-19 vaccine;
Allergic to any component of the study vaccine (e.g. aluminum, histidine, etc.)
Known or suspected diseases include：Severe respiratory diseases, severe liver and kidney diseases, hypertension (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attacks of chronic diseases;
Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
Has a history of convulsions, epilepsy, encephalopathy，long term history of alcohol and drug abuse, history of thyroidectomy, infectious diseasesor mental illness or family history（lineal）;
With Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.;
Has a history of coagulation dysfunction (e.g. coagulation factors deficiency and coagulation diseases);
Absence of spleen or splenectomy, functional absence of spleen caused by any condition
Anti -TB (TB) treatment is under way.
Patients receiving immunoenhancement or inhibitor therapy within 3 months (continuous oral or IV administration for more than 14 days);
Received other vaccines within 14 days before vaccination；
Received blood products before within 3 months before vaccination;
Received other investigational drugs within 6 months before vaccination;
Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit
Other circumstances judged by investigators that are not suitable for this clinical trial

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 1,800 participants (actual)

Study arms

Experimental
Subject last vaccination time is within 30-90 days
Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 30-90 days
Biological: Recombinant COVID-19 Vaccine (CHO cell) · Biological: COVID-19 vaccine (Vero cells)
Experimental
Subject last vaccination time is within 91-180 days
Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 91-180 days
Biological: Recombinant COVID-19 Vaccine (CHO cell) · Biological: COVID-19 vaccine (Vero cells)
Experimental
Subject last vaccination time more than 181 days
Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time more than 181 days
Biological: Recombinant COVID-19 Vaccine (CHO cell) · Biological: COVID-19 vaccine (Vero cells)

Interventions

BiologicalRecombinant COVID-19 Vaccine (CHO cell)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm
BiologicalCOVID-19 vaccine (Vero cells)
Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm

What researchers measure

Primary outcomes

GMT of anti- SARS-CoV-2 neutralizing antibody
Time frame: 14th day after vaccination
GMT of anti- SARS-CoV-2 neutralizing antibody
Time frame: 28th day after vaccination
4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: 14th day after vaccination
4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: 28th day after vaccination

Secondary outcomes

GMT of anti- SARS-CoV-2 neutralizing antibody
Time frame: before vaccination
GMT of anti-SARS-CoV-2 IgG antibody
Time frame: 28th day after vaccination
4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: before vaccination
4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: 28th day after vaccination
GMI of anti-SARS-CoV-2 IgG antibody
Time frame: before vaccination
GMI of anti-SARS-CoV-2 IgG antibody
Time frame: 28th day after vaccination
Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time frame: before vaccination
Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time frame: 28th day after vaccination
The incidence and serverity of any adverse reactions
Time frame: within 30 minutes after vaccination
The incidence and serverity of solicited adverse events
Time frame: within 30 minutes after vaccination
The incidence and severity of adverse reactions
Time frame: within 0-7 days after vaccination
The incidence and serverity of solicited adverse events
Time frame: within 0-7 days after vaccination
The incidence and severity of unsolicited adverse reactions
Time frame: within 8-30 days after vaccination
The incidence and serverity of solicited adverse events
Time frame: within 8-30 days after vaccination
The incidence of SAE observed
Time frame: after vaccination and up to 6 months after full course of immunization
The incidence of AESI observed
Time frame: after vaccination and up to 6 months after full course of immunization

Other outcomes

The vaccine efficay of recombinant COVID-19 vaccine (CHO cells) against COVID-19, severe cases and deaths
Time frame: 14th day after vaccination
Anti-SARS-CoV-2 neutralizing antibody
Time frame: 3th month, 6th month, 9th month and 12th month after full course of immunization
Anti-SARS-CoV-2 GMT of IgG antibody
Time frame: 3th month, 6th month, 9th month and 12th month after full course of immunization
Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time frame: 3th month, 6th month, 9th month and 12th month after full course of immunization

Study locations

1 site

Sheikh Khalifa Medical City
Seha, Abu Dhab 519000, United Arab Emirates

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05033847
Lead sponsor: National Vaccine and Serum Institute, China
Collaborators: China National Biotec Group Company Limited, Lanzhou Institute of Biological Products Co., Ltd
Responsible party: Sponsor
First posted: Sep 5, 2021
Start date: Sep 12, 2021
Primary completion: Nov 2023 (estimated)
Completion: Jan 2024 (estimated)
Last update: Feb 2, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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