COVID-19Phase 3NCT05599516
Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial
A Phase 3 study testing LIBP-Rec-Vaccine and BIBP-Rec-Vaccine in people with COVID-19 and Coronavirus Infections, run by National Vaccine and Serum Institute, China at 1 site in United Arab Emirates.
Trial summary
This clinical trial adopts a randomized, double-blind and placebo-controlled design. A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of… 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, Coronavirus Infections
- What is being tested?
- LIBP-Rec-Vaccine and BIBP-Rec-Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16,000 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 4 Nov 2022to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range: healthy population aged ≥18;
- Judged by the investigator that the health condition is well after inquiry and physical examination;
- Cohort 1: participants vaccinated with ≥2 doses of inactivated COVID-19 vaccines for ≥6 months since the last dose of vaccination; Cohort 2: participants vaccinated with ≥2 doses of mRNA COVID-19 vaccines for ≥6 months since the last dose of vaccination;
- Be able and willing to complete all prescribed study schedules during the whole study period;
- The participant himself/herself is able and willing to understand study procedures, sign the informed consent form voluntarily after informed consent and comply to requirements of the study protocol.
Who cannot join
- Symptomatic and suspected COVID 19 infection positive ;
- Urine pregnancy test is positive; Women of childbearing age who have positive urine pregnancy test, who are pregnant, lactating, or women who have planned pregnancy within 6 months;
- Auxiliary temperature before vaccination is ≥37.3℃ (tympanic/forehead temperature ≥37.8℃);
- Previous allergy history of vaccine vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain, etc.) or allergy to known components of COVID-19 vaccine;
- Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
- With known immunological impairment or compromised immunological function diagnosed by the hospital;
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- Received whole blood, plasma and immunoglobulin therapy within 1 month;
- Known or suspected of suffering from the following diseases: acute or chronic active respiratory diseases, severe cardiovascular diseases [cardiopulmonary failure, hypertension uncontrollable by drugs (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg)], acute infection, active phase of chronic disease, liver and kidney diseases, severe diabetes, malignant tumor, infectious skin diseases or severe skin allergy, HIV infection, etc. (Examination report can be provided)
- Received live attenuated vaccine within one month before vaccination;
- Received inactivated vaccine within 14 days before vaccination;
- Other contraindications related to vaccination that investigators believe.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Sheikh Khalifa Medical City
SEHA, Abu Dhab, 519000
Yunkai Yang, Prof., +8613601126881, yangyunkai@sinopharm.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of LIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and BIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) in Healthy Population Aged 18 and Above
This clinical trial adopts a randomized, double-blind and placebo-controlled design.
A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine, BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm.
Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine or BIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.
- Conditions
- COVID-19, Coronavirus Infections
- Being tested
- LIBP-Rec-Vaccine, BIBP-Rec-Vaccine, placebo
- Keywords
- COVID-19
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIBP-Rec-VaccineBiological
Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
BIBP-Rec-VaccineBiological
Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm
placeboBiological
Intramuscular injection of placebo in the deltoid muscle of the upper arm
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 LIBP-Rec-Vaccine Group | Experimental | Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months Receives: Biological: LIBP-Rec-Vaccine |
| Cohort 1 BIBP-Rec-Vaccine Group | Experimental | Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months Receives: Biological: BIBP-Rec-Vaccine |
| Cohort 1 placebo control group | Placebo comparator | Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months Receives: Biological: placebo |
| Cohort 2 LIBP-Rec-Vaccine Group | Experimental | Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months Receives: Biological: LIBP-Rec-Vaccine |
| Cohort 2 BIBP-Rec-Vaccine Group | Experimental | Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months Receives: Biological: BIBP-Rec-Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above.
Rates of cohort 1 subjects not infected with COVID-19
Measured: 14th day after vaccination
Secondary outcomes (19)
Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 asymptomatic infection in healthy population aged 18 and above
Rates of cohort 1 subjects who are not asymptomatic infection with COVID-19
Measured: 14th day after vaccination
Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 severe cases in healthy population aged 18 and above
Rates of cohort 1 subjects who are not severe cases with COVID-19
Measured: 14th day after vaccination
Cohort 1: Efficacy of LIBP-Rec-Vaccine / BIBP-Rec-Vaccine against COVID-19 related deaths in healthy population aged 18 and above.
Rates of cohort 1 subjects who are not related deaths with COVID-19
Measured: 14th day after vaccination
GMT of subject's anti-SARS-CoV-2 neutralizing antibody is non-inferior to that of Cohort 1（ LIBP-Rec-Vaccine / BIBP-Rec-Vaccine）
Cohort 2 Immunogenicity subgroup only
Measured: 14th day after vaccination
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
Measured: 14th day、28th day after vaccination
GMI of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
Measured: 14th day、28th day after vaccination
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
Measured: 14th day、28th day after vaccination
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
Measured: 3th month、6th month after vaccination
GMI of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
Measured: 3th month、6th month after vaccination
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
Measured: 3th month、6th month after vaccination
The incidence and severity of any adverse reactions
Measured: within 30 minutes after vaccination
The incidence and severity of solicited adverse events
Measured: within 30 minutes after vaccination
The incidence and severity of solicited adverse reactions
Measured: within 0-7 days after vaccination
The incidence and severity of unsolicited adverse reactions
Measured: within 0-7 days after vaccination
The incidence and severity of solicited adverse reactions
Measured: within 8-30 days after vaccination
The incidence and severity of solicited adverse events
Measured: within 8-30 days after vaccination
The incidence of SAE observed
Measured: Within 6 months of vaccination
The incidence of AESI observed
Measured: Within 6 months of vaccination
Cross-neutralizing effect of recombinant COVID-19 vaccine against different variants (prototype strain, Delta, Omicron and other potential emerging dominant circulating variants)
Immunogenicity subgroup only
Measured: 14th day after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start4 Nov 2022
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Vaccine and Serum Institute, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China National Biotec Group Company Limited, Lanzhou Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599516
- Sponsor's protocol ID
- CNBG-REC-2022006
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of LIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and BIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) in Healthy Population Aged 18 and Above
- ClinicalTrials.gov ID
- NCT05599516
- Acronym / sponsor ID
- CNBG-REC-2022006
- Conditions
- COVID-19, Coronavirus Infections
- Keywords
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- National Vaccine and Serum Institute, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- China National Biotec Group Company Limited, Lanzhou Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd.
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial adopts a randomized, double-blind and placebo-controlled design.
A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine, BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm.
Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine or BIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 LIBP-Rec-Vaccine Group | Experimental | Biological: LIBP-Rec-VaccineSubject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months |
| Cohort 1 BIBP-Rec-Vaccine Group | Experimental | Biological: BIBP-Rec-VaccineSubject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months |
| Cohort 1 placebo control group | Placebo comparator | Biological: placeboSubject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months |
| Cohort 2 LIBP-Rec-Vaccine Group | Experimental | Biological: LIBP-Rec-VaccineSubject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months |
| Cohort 2 BIBP-Rec-Vaccine Group | Experimental | Biological: BIBP-Rec-VaccineSubject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range: healthy population aged ≥18;
- Judged by the investigator that the health condition is well after inquiry and physical examination;
- Cohort 1: participants vaccinated with ≥2 doses of inactivated COVID-19 vaccines for ≥6 months since the last dose of vaccination; Cohort 2: participants vaccinated with ≥2 doses of mRNA COVID-19 vaccines for ≥6 months since the last dose of vaccination;
- Be able and willing to complete all prescribed study schedules during the whole study period;
- The participant himself/herself is able and willing to understand study procedures, sign the informed consent form voluntarily after informed consent and comply to requirements of the study protocol.
Key exclusion criteria (11 listed)
- Symptomatic and suspected COVID 19 infection positive ;
- Urine pregnancy test is positive; Women of childbearing age who have positive urine pregnancy test, who are pregnant, lactating, or women who have planned pregnancy within 6 months;
- Auxiliary temperature before vaccination is ≥37.3℃ (tympanic/forehead temperature ≥37.8℃);
- Previous allergy history of vaccine vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain, etc.) or allergy to known components of COVID-19 vaccine;
- Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIBP-Rec-VaccineIntramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm | Biological | Cohort 1 LIBP-Rec-Vaccine Group, Cohort 2 LIBP-Rec-Vaccine Group |
| BIBP-Rec-VaccineIntramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm | Biological | Cohort 1 BIBP-Rec-Vaccine Group, Cohort 2 BIBP-Rec-Vaccine Group |
| placeboIntramuscular injection of placebo in the deltoid muscle of the upper arm | Biological | Cohort 1 placebo control group |
Primary outcome
Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above.
Time frame: 14th day after vaccination
Rates of cohort 1 subjects not infected with COVID-19
19 secondary outcomes
Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 asymptomatic infection in healthy population aged 18 and above
Time frame: 14th day after vaccination
Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 severe cases in healthy population aged 18 and above
Time frame: 14th day after vaccination
Cohort 1: Efficacy of LIBP-Rec-Vaccine / BIBP-Rec-Vaccine against COVID-19 related deaths in healthy population aged 18 and above.
Time frame: 14th day after vaccination
GMT of subject's anti-SARS-CoV-2 neutralizing antibody is non-inferior to that of Cohort 1（ LIBP-Rec-Vaccine / BIBP-Rec-Vaccine）
Time frame: 14th day after vaccination
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Time frame: 14th day、28th day after vaccination
GMI of subject's anti- SARS-CoV-2 neutralizing antibody
Time frame: 14th day、28th day after vaccination
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody
Time frame: 14th day、28th day after vaccination
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Time frame: 3th month、6th month after vaccination
GMI of subject's anti- SARS-CoV-2 neutralizing antibody
Time frame: 3th month、6th month after vaccination
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody
Time frame: 3th month、6th month after vaccination
The incidence and severity of any adverse reactions
Time frame: within 30 minutes after vaccination
The incidence and severity of solicited adverse events
Time frame: within 30 minutes after vaccination
The incidence and severity of solicited adverse reactions
Time frame: within 0-7 days after vaccination
The incidence and severity of unsolicited adverse reactions
Time frame: within 0-7 days after vaccination
The incidence and severity of solicited adverse reactions
Time frame: within 8-30 days after vaccination
The incidence and severity of solicited adverse events
Time frame: within 8-30 days after vaccination
The incidence of SAE observed
Time frame: Within 6 months of vaccination
The incidence of AESI observed
Time frame: Within 6 months of vaccination
Cross-neutralizing effect of recombinant COVID-19 vaccine against different variants (prototype strain, Delta, Omicron and other potential emerging dominant circulating variants)
Time frame: 14th day after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LIBP-Rec-Vaccine and BIBP-Rec-Vaccine in people with COVID-19 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 5 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 10 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 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. Some participants in this study may receive a placebo. 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?
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?
Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above. (time frame: 14th day after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2022.