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COVID-19Phase 3COVID-19NCT05382871

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

A Phase 3 study testing BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell), WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell) and COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19, run by China National Biotec Group Company Limited at 1 site in Hong Kong.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 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. 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
What is being tested?
BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell), WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell) and COVID-19 Vaccine (Vero Cell), Inactivated
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,804 participants
Where
1 siteHong Kong
Study dates
27 May 2022to 31 Mar 2024
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 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/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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Conditions
COVID-19
Being tested
BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell), WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell), COVID-19 Vaccine (Vero Cell), Inactivated
Medical subject headings
COVID-19

What participants receive

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

  • BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)Biological

    intramuscular injection in the deltoid muscle

  • WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)Biological

    intramuscular injection in the deltoid muscle

  • COVID-19 Vaccine (Vero Cell), InactivatedBiological

    intramuscular injection in the deltoid muscle

Study groups in NCT05382871
Study groupRoleWhat they receive
1: BIBP Inactivated COVID-19 vaccine (Omicron)Experimentalsubjects will be blinded and receive two doses of BIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine
Receives: Biological: BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
2: WIBP Inactivated COVID-19 vaccine (Omicron)Experimentalsubjects will be blinded and receive two doses of WIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine
Receives: Biological: WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
3：BIBP Inactivated COVID-19 vaccine (Omicron)Experimentalsubjects will be blinded and receive two doses of BIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine
Receives: Biological: BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
4: WIBP Inactivated COVID-19 vaccine (Omicron)Experimentalsubjects will be blinded and receive two doses of WIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine
Receives: Biological: WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
5：Inactivated COVID-19 Vaccine (prototype)Active comparatorsubjects will be blinded and receive two doses of Inactivated COVID-19 Vaccine (prototype) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine
Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
6：Inactivated COVID-19 Vaccine (prototype)Active comparatorsubjects will be blinded and receive two doses of Inactivated COVID-19 Vaccine (prototype) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine
Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated

What is being measured

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

  1. The Geometric Mean Titer （GMT） of anti-omicron neutralizing antibody

    Measured: 28 days after sequential vaccination of 2 doses

  2. The 4-fold rise rate of anti-omicron neutralizing antibody

    Measured: 28 days after sequential vaccination of 2 doses

Secondary outcomes (8)

  1. The GMT of anti-omicron neutralizing antibody

    Measured: 14 days after sequential vaccination of 2 doses

  2. The 4-fold rise rate of anti-omicron neutralizing antibody

    Measured: 14 days after sequential vaccination of 2 doses

  3. Specific cellular immune response

    Measured: within 28 days after vaccination

  4. The GMT of anti-omicron Immunoglobulin G (IgG) antibody

    Measured: 28 days after sequential vaccination of 2 doses

  5. The proportions of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64

    Measured: 28 days after sequential vaccination of 2 doses

  6. The proportion of subjects with neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64

    Measured: on 3rd month, 6th month, 9th month, and 12th month after vaccination

  7. The incidence of any adverse reactions/events

    Measured: 28 days after each immunization

  8. The incidence of serious adverse events (SAE) and adverse events special interest (AESI)

    Measured: from 1st booster dose and up to 6 months following 2nd booster dose

Timeline

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

  1. First posted19 May 2022
  2. Study start27 May 2022
  3. Primary completion27 Jul 2023 (estimated)
  4. Study completion31 Mar 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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,804 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382871
Sponsor's protocol ID
CNBG-O-2022002
Acronym
COVID-19
Status last verified
May 2023
First submitted
17 May 2022
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell), WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell) and COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19, run by China National Biotec Group Company Limited at 1 site in Hong Kong.

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 15 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 18 Jun 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 Hong Kong. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Geometric Mean Titer （GMT） of anti-omicron neutralizing antibody (time frame: 28 days after sequential vaccination of 2 doses). The study lists 2 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 NCT05382871.

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 18 Jun 2023.

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