A Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell)

NCT05293548
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Unknown
clinicaltrials.gov
Participants
516
clinicaltrials.gov
Lead sponsor
National Vaccine and Serum Institute, China
clinicaltrials.gov
Start date
2022-05-25
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Summary
A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group.
clinicaltrials.gov
Short title
A Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell)
clinicaltrials.gov
Official title
A Randomized, Controlled Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell) in Population Aged 18 Years and Above
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Unknown
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2023-08-01
clinicaltrials.gov
First posted
2022-03-24
clinicaltrials.gov
Registry last updated
2023-02-02
clinicaltrials.gov
Primary completion date
2023-05-01
clinicaltrials.gov
Start date
2022-05-25
clinicaltrials.gov

Actual participants
516
clinicaltrials.gov
Participants
516
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
2
clinicaltrials.gov
Randomisation ratio
1:1
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
National Vaccine and Serum Institute, China
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05293548
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05293548
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age

    Timeframe: 14 days after sequential immunization of one booster dose

  2. the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age

    Timeframe: 14 days after a single dose of the booster vaccine

  3. The incidence rate of any adverse reactions/events

    Timeframe: within 30 minutes after vaccination

  4. The incidence severity of any adverse reactions/events

    Timeframe: within 30 minutes after vaccination

  5. The incidence rate of solicited adverse reactions/events

    Timeframe: within 0-7 days after vaccination

  6. The incidence severity of solicited adverse reactions/events

    Timeframe: within 0-7 days after vaccination

  7. The incidence rate of solicited adverse reactions/events

    Timeframe: within 8-30 days after vaccination

  8. The incidence severity of solicited adverse reactions/events

    Timeframe: within 8-30 days after immunization

  9. The incidence of SAE observed

    Timeframe: up to 12 months after full course of immunization

  10. The incidence of AESI observed

    Timeframe: up to 12 months after full course of immunization

  1. 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age

    Timeframe: 28 days after sequential immunization of one booster dose

  2. GMT of anti-omicron neutralizing antibody in adults ≥18 years of age

    Timeframe: 28 days after sequential immunization of one booster dose

  3. 4-fold rise rate of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age

    Timeframe: 28 days after sequential immunization of one booster dose

  4. GMT of anti-omicron IgG antibody in adults ≥18 years of age

    Timeframe: before booster vaccination and 28 days after a single dose of the booster vaccine

  5. 4-fold rise rate of anti-omicron IgG antibody in adults ≥18 years of age

    Timeframe: before booster vaccination and 28 days after a single dose of the booster vaccine

  6. proportions of neutralizing antibody tittered 1: 16, 1: 32 and 1: 64 of anti-SARS-CoV-2 IgG antibody in adults ≥18 years of age

    Timeframe: before booster vaccination and 28 days after a single dose of the booster vaccine

  7. GMI of anti-omicron IgG antibody in adults ≥18 years of age

    Timeframe: before booster vaccination and 28 days after a single dose of the booster vaccine

  8. GMTs of anti-omicron neutralizing antibody

    Timeframe: 3 months, 6 months, 9 months and 12 months after sequential immunization

  9. IgG antibody of anti-omicron neutralizing antibody

    Timeframe: 3 months, 6 months, 9 months and 12 months after sequential immunization

  10. the proportions of neutralizing antibody titered 1: 16, 1: 32 and 1: 64

    Timeframe: 3 months, 6 months, 9 months and 12 months after sequential immunization

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • Age: population aged 18 years and above;
  • Judged by the investigator that the health condition is well after inquiry and physical examination;
  • Vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine (Vero Cell vaccine) 6 months prior to study screening and according to product insert;
  • Female participants who are not pregnant or nursing or at the time of enrolment (confirmed via negative urine pregnancy test), and do not have plans to become pregnant within the first 6 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before study inclusion and initiation;
  • Be able and willing to provide written informed consent to participate in the study and complete all study requirements according to the study protocol;

  • COVID-19 infection positive patients (including suspected or asymptomatic cases);
  • Have a history of SARS and MERS infection;
  • Have been vaccinated by any COVID-19 Vaccines other than Vero Cell vaccine；
  • Have an axillary temperature 37.3 (forehead temperature 37.8℃℃);
  • Have had previous allergic reactions to vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic oedema or abdominal pain) or allergy to known components of COVID-19 vaccine;
  • History of thrombocytopenia or other coagulation disorders;
  • Patients with known immunological impairment or immunocompromised.
  • Received whole blood, blood products, plasma and/or immunoglobulin therapy within 3 months before study enrollment
  • Have known or suspected severe illness such as respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumour, infectious or allergic skin disease, human immunodeficiency virus (HIV) infection (test report available);
  • Diagnosed with serious cardiovascular diseases such as cardiopulmonary failure, drug-uncontrolled hypertension (Systolic blood pressure 160 mmHg and/or diastolic blood pressure 95 mmHg).
  • Received live attenuated vaccines within 1 month before study enrollment;
  • Received inactivated vaccines within 14 days before study enrollment;
  • Received other investigational drugs within 6 months before study enrollment;
  • Other vaccination-related contraindications considered by investigators.
Sources for eligibility
clinicaltrials.gov

  • Sheikh Khalifa Medical CitySEHA, United Arab Emirates
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (3)

Lead sponsors (1)

Conditions (1)

Targets (1)