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COVID-19Phase 3NCT05616754

A Trial Evaluate the Immunogenicity and Safety of Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell)

A Phase 3 study testing Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells) and Recombinant Novel Coronavirus Protein Vaccine (CHO cells) in people with COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in Uzbekistan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The study was designed as a randomized, blind and controlled trial. A total of 300 patients aged 18 and above who were immunized with recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months (60 patients aged 60 and above) were randomly and blind divided into the experimental group and the… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells) and Recombinant Novel Coronavirus Protein Vaccine (CHO cells)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUzbekistan
Study dates
7 Nov 2022to 30 Sep 2023
Phase
Phase 3
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Age eligible for observation in this clinical trial: adults aged 18 years and above
  • Subjects voluntarily participate in this study, sign informed consent, provide legal identification, and understand and comply with the requirements of the test protocol
  • More than 4 months after the completion of the whole course of recombinant novel coronavirus protein vaccine (CHO cell) basic immunization or more than 4 months after the completion of the novel coronavirus mRNA vaccine basic immunization
  • Female and male participants of childbearing age took effective contraception during the study period

Who cannot join

  • Prior history of severe allergy to any vaccine or to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angineurotic edema, etc.;
  • Suspected or confirmed fever (axillary temperature ≥37.3℃/ mouth temperature ≥37.5℃) within 72 hours before enrollment, or armpit temperature ≥37.3℃/ mouth temperature ≥37.5℃ on the day of enrollment;
  • Confirmed cases of COVID-19 infection, asymptomatic infected persons or positive nucleic acid test history of COVID-19;
  • Uncontrolled lymphoproliferative disease, unremission stage of aplastic anemia, active stage of primary immune thrombocytopenia (ITP), uncontrolled stage of coagulation disease, etc.
  • a history of congenital or acquired immunodeficiency or autoimmune disease; Absence of spleen, or history of splenic surgery, trauma, or immunomodulator treatment within 6 months, such as immunosuppressive dose of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; But topical use (such as ointments, eye drops, inhalants or nasal sprays) is permitted;
  • Subunit vaccine and inactivated vaccine should be administered within 14 days before vaccination, and live attenuated vaccine should be administered within 30 days before vaccination;
Show all 11Show fewer
  • Patients with malignant tumors who are undergoing chemotherapy, radiotherapy or immunotherapy before and after surgery; Patients with organ transplant status;
  • People with uncontrolled epilepsy and other progressive neurological diseases (e.g. Transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.);
  • Patients with acute disease, or acute episodes of chronic disease, or uncontrolled severe chronic disease, such as medically uncontrolled hypertension (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg);
  • lactating or pregnant women;
  • The investigator believes that the subject has any disease or condition that could put the subject at risk; The subject is unable to complete the trial as required by the protocol, and there are circumstances that interfere with the assessment of vaccine response.

Trial locations and contacts

1 site in 1 country.

Akhmedova Guzal, Bachelor contact

998-935281313

abidovagoga@gmail.com

Uzbekistan1 site, 1 recruiting

  • Uzbekistan, Tashkent city, Said baraka street 10

    Tashkent, 100012

    Akhmedova Guzal, Bachelor, 998-935281313

    Recruiting

Other trials in Uzbekistan

About this study

Official title: Anhui Zhifei Longcom Biologic Pharmacy co. Ltd.

The study was designed as a randomized, blind and controlled trial. A total of 300 patients aged 18 and above who were immunized with recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months (60 patients aged 60 and above) were randomly and blind divided into the experimental group and the control group, and received the experimental vaccine and the control vaccine, respectively.

In addition, 100 patients over 4 months after the completion of basic immunization with COVID-19 mRNA vaccine were selected as the open observation group, all of whom received 1 dose of experimental vaccine.

Read the detailed description

The improved vaccine was developed against the Delta and Omicron COVID-19 variants. The overall design of this clinical trial was as follows: A total of 300 patients aged 18 and above who completed the basic immunization of recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months were randomly divided into the experimental group and the control group in a blind way, and were inoculated with the experimental vaccine and the control vaccine respectively. In addition, 100 patients over 4 months after the completion of basic immunization with COVID-19 mRNA vaccine were selected as the open observation group, all of whom received 1 dose of experimental vaccine. The main objective was to evaluate the immunogenicity and safety of Omicron-Delta recombinant novel coronavirus protein vaccine (CHO cells) against Omicron variants of novel coronavirus in people aged 18 years and above.

Conditions
COVID-19
Being tested
Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells), Recombinant Novel Coronavirus Protein Vaccine (CHO cells)
Keywords
IgG, GMC
Medical subject headings
COVID-19

What participants receive

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

  • Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells)Biological

    The antigen protein of this product is designed to be expressed in tandem with Delta variant R319-N356 and Omicron variant R319-N356. The antigen is called DO-RBD for short.

  • Recombinant Novel Coronavirus Protein Vaccine (CHO cells)Biological

    This strain was made from the NCP-RBD receptor binding region of the spike glycoprotein of novel coronavirus expressed in recombinant CHO cells, which was purified and added with aluminum hydroxide adjuvant

Study groups in NCT05616754
Study groupRoleWhat they receive
Test groupExperimentalPeople more than 4 months after completing basic immunization with recombinant novel coronavirus protein vaccine (CHO cells)
Receives: Biological: Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells)
control groupActive comparatorPeople more than 4 months after completing basic immunization with recombinant novel coronavirus protein vaccine (CHO cells)
Receives: Biological: Recombinant Novel Coronavirus Protein Vaccine (CHO cells)
Observation groupExperimentalPeople over 4 months after completing basic immunization with COVID-19 mRNA vaccine
Receives: Biological: Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells)

What is being measured

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

  1. Immunogenic end points

    Geometric mean concentration (GMC) of RBD protein-binding Antibody (IgG) against Omicron variant of novel coronavirus at 14 days after vaccination in experimental group and control group.

    Measured: 6 months

Secondary outcomes (5)

  1. Immunogenic end points 2

    RBD protein-bound antibody (IgG) growth ratio (GMI) and positive turnover rate for Omicron variant of novel coronavirus at 14 days after vaccination in experimental group and control group;

    Measured: 6 months

  2. Immunogenic end points 3

    RBD protein-binding antibody (IgG) GMC, GMI and positive turnover were detected against the primary COVID-19 strain and Delta variant 14 days after vaccination in experimental group.

    Measured: 6 months

  3. Immunogenic end points 4

    RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants 6 months after vaccination in the experimental group

    Measured: 6 months

  4. Immunogenic end points 5

    RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants were detected 14 days after vaccination in the observation group

    Measured: 6 months

  5. Immunogenic end points 6

    RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants in the observation group for 6 months

    Measured: 6 months

Timeline

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

  1. First posted15 Nov 2022
  2. Study start7 Nov 2022
  3. Primary completion30 Jul 2023 (estimated)
  4. Study completion30 Sep 2023 (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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05616754
Sponsor's protocol ID
LKM-2022-NCV-GJ01
Status last verified
Nov 2022
First submitted
11 Nov 2022
Last updated
15 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li D, Duan M, Wang X, Gao P, Zhao X, Xu K, Gao GF. Neutralization of BQ.1, BQ.1.1, and XBB with RBD-Dimer Vaccines. N Engl J Med. 2023 Mar 23;388(12):1142-1145. doi: 10.1056/NEJMc2216233. Epub 2023 Mar 1. No abstract available.

    PubMed 36856580

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells) and Recombinant Novel Coronavirus Protein Vaccine (CHO cells) in people with COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in Uzbekistan.

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 4 inclusion and 11 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 15 Nov 2022. 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 Uzbekistan. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Akhmedova Guzal, Bachelor (998-935281313, abidovagoga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenic end points (time frame: 6 months). 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 NCT05616754, 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 15 Nov 2022.

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