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COVID-19 PneumoniaPhase 1/2NCT05069129

Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above

A Phase 1/2 study testing Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08), Inactivated COVID-19 vaccine (Vero cells) and 3 doses Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) in people with COVID-19 Pneumonia and Coronavirus Infections, run by National Vaccine and Serum Institute, China at 1 site in United Arab Emirates.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 4-6… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Pneumonia, Coronavirus Infections
What is being tested?
Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08), Inactivated COVID-19 vaccine (Vero cells) and 3 doses Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,848 participants
Where
1 siteUnited Arab Emirates
Study dates
14 Oct 2021to Feb 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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（sequential clinical trial group）
  • Never vaccinated COVID-19 vaccine（safety observation group）;
  • 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 3 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.

Who cannot join

  • 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.)
Show all 18Show fewer
  • 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 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

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site, 1 recruiting

  • Sheikh Khalifa Medical City

    SEHA, Abu Dhab, 519000

    Yunkai Yang, Prof., +8613601126881, yangyunkai@sinopharm.com

    Recruiting

Other trials in United Arab Emirates

About this study

Official title: A Randomized, Controlled Phase I and Sequential Study to Evaluate the Safety and Immunogenicity Following Immunization of GEN2-Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above

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 4-6 months, 7-9 months and >9 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.

Being tested
Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08), Inactivated COVID-19 vaccine (Vero cells), 3 doses Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)
Keywords
COVID-19
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)Biological

    Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) in the deltoid muscle of the upper arm

  • Inactivated COVID-19 vaccine (Vero cells)Biological

    Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm

  • 3 doses Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)Biological

    Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) in the deltoid muscle of the upper arm on 0，30，60 days

Study groups in NCT05069129
Study groupRoleWhat they receive
Subject last vaccination time is within 4-6 months（sequential clinical trial group）ExperimentalSubject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 4-6 months
Receives: Biological: Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08); Biological: Inactivated COVID-19 vaccine (Vero cells)
Subject last vaccination time is within 7-9 months（sequential clinical trial group）ExperimentalSubject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 91-180 days 7-9 months
Receives: Biological: Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08); Biological: Inactivated COVID-19 vaccine (Vero cells)
Subject last vaccination time more than 9 months（sequential clinical trial group）ExperimentalSubject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time more than 9 months
Receives: Biological: Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08); Biological: Inactivated COVID-19 vaccine (Vero cells)
Safety Observation GroupExperimentalSubject have been vaccinated with three doses of Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) on 0，30，60 days
Receives: Biological: 3 doses Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence and serverity of any adverse reactions

    Measured: within 30 minutes after vaccination

  2. The incidence and serverity of solicited adverse events

    Measured: within 30 minutes after vaccination

  3. The incidence and serverity of solicited adverse reactions

    Measured: within 0-7 days after vaccination

  4. The incidence and severity of unsolicited adverse reactions

    Measured: within 0-7 days after vaccination

  5. The incidence and serverity of solicited adverse reactions

    Measured: within 8-30 days after vaccination

  6. The incidence and serverity of solicited adverse events

    Measured: within 8-30 days after vaccination

  7. The incidence of SAE observed

    Measured: after vaccination and up to 6 months after full course of immunization.

  8. The incidence of AESI observed

    Measured: after vaccination and up to 6 months after full course of immunization

  9. GMT of subject's anti- SARS-CoV-2 neutralizing antibody

    Measured: 15th day after vaccination

  10. GMT of subject's anti- SARS-CoV-2 neutralizing antibody

    Measured: 30th day after vaccination

  11. Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    Measured: 15th day after vaccination

  12. Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    Measured: 30th day after vaccination

Secondary outcomes (14)

  1. Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody

    Measured: before vaccination

  2. Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody

    Measured: 30th day after the full course of vaccination

  3. Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    Measured: before vaccination

  4. Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    Measured: 30th day after the full course of vaccination

  5. GMI of subject's anti-SARS-CoV-2 IgG antibody

    Measured: before vaccination

  6. GMI of subject's anti-SARS-CoV-2 IgG antibody

    Measured: 30th day after the full course of vaccination

  7. Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64

    Measured: before vaccination

  8. Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64

    Measured: 30th day after the full course of vaccination

  9. Rate of Anti-SAR-CoR-2 neutralizing antibody

    only sequential clinical trial group

    Measured: the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination

  10. Rate of GMT of IgG antibody

    only sequential clinical trial group

    Measured: the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination

  11. Rate of the titer of neutralizing antibody ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64

    only sequential clinical trial group

    Measured: the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination

  12. Rate of Anti-SAR-CoR-2 neutralizing antibody

    only Safety Observation Group

    Measured: the 6th month, 12th month after the full course of vaccination

  13. Rate of GMT of IgG antibody

    only Safety Observation Group

    Measured: the 6th month, 12th month after the full course of vaccination

  14. Rate of the titer of neutralizing antibody ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64

    only Safety Observation Group

    Measured: the 6th month, 12th month after the full course of vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2021
  2. Study start14 Oct 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionFeb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,848 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05069129
Sponsor's protocol ID
CNBG-REC-2021003
Status last verified
Jan 2023
First submitted
3 Oct 2021
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kaabi NA, Yang YK, Du LF, Xu K, Shao S, Liang Y, Kang Y, Su JG, Zhang J, Yang T, Hussein S, ElDein MS, Yang SS, Lei W, Gao XJ, Jiang Z, Cong X, Tan Y, Wang H, Li M, Mekki HM, Zaher W, Mahmoud S, Zhang X, Qu C, Liu DY, Zhang J, Yang M, Eltantawy I, Hou JW, Lei ZH, Xiao P, Wang ZN, Yin JL, Mao XY, Zhang J, Qu L, Zhang YT, Yang XM, Wu G, Li QM. Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial. Nat Commun. 2022 Jun 27;13(1):3654. doi: 10.1038/s41467-022-31379-0.

    PubMed 35760812

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08), Inactivated COVID-19 vaccine (Vero cells) and 3 doses Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) in people with COVID-19 Pneumonia and Coronavirus Infections, run by National Vaccine and Serum Institute, China at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and serverity of any adverse reactions (time frame: within 30 minutes after vaccination). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05069129, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.

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