COVID-19Early Phase 1NCT05928455
The Immunogenicity and Safety Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine LYB001
A Early Phase 1 study testing LYB001 and CoronaVac in people with COVID-19 and Vaccine Reaction, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to assess the immunogenicity and safety following a heterologous booster dose of recombinant SARS-CoV-2 vaccine (CHO cell) LYB001 in adults 18-59 years of age completed two- or three-dose inactivated COVID-19 vaccine. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Vaccine Reaction
- What is being tested?
- LYB001 and CoronaVac
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2022to 30 Jun 2023
- Phase
- Early Phase 1
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 18-59 years, including both males and females;
- Subjects who agree to participate in this clinical trial voluntarily and sign the informed consent form, are capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
- Subjects who have completed two- or three-dose inactivated COVID-19 vaccine at 6-12 months earlier.
- For female participants of childbearing potential, effective contraception measures should be used within 2 weeks prior to participation in this study and the results of pregnancy test is required to be negative. Participants should voluntarily agree to use effective contraceptive measures from the time of signing the informed consent form to the end of the study (effective contraceptive measures including oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).
Who cannot join
- Receipt of any COVID-19 prophylactic medication (e.g., receipt history of any approved or under developing COVID-19 vaccines other than inactivated vaccine), or previous vaccination history other than other than two or three doses of inactivated vaccination;
- Abnormal vital signs with clinical significance prior to enrolment, with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or axillary body temperature ≥ 37.3°C prior to enrolment; abnormal results of laboratory screening tests which was clinically significant judged by clinicians prior to enrolment.
- Known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients;
- History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
- History of COVID-19, or history of close contact with confirmed/suspected COVID-19 patients, or positive results for SARS-CoV-2 nucleic acid tests at screening;
- Administration of antipyretics, painkillers or anti-allergy drugs within 24 hours prior to enrolment;
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- Receipt of any live attenuated vaccine within 28 days prior to vaccination and other vaccines, such as subunit and inactivated vaccine within 14 days prior to vaccination;
- Receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned use during the study period.
- Subjects with the following diseases:
- Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment；
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.；
- Congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids；
- Currently suffering from or diagnosed with infectious diseases, positive screening results for hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, human immunodeficiency virus antibody；
- History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders；
- Asplenia, or functional asplenia；
- Presence of severe, uncontrollable or hospitalized cardiovascular diseases, diabetes, blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors;
- Contraindications to IM injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage.
- Drug or alcohol abuse (alcohol intake ≥ 14 units per week) which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures;
- Pregnant or lactating females;
- Having participated or participating in COVID-19 related clinical trials, and those participating or planning to participate in other clinical trials during the study period;
- Presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College
Chengdu, Sichuan, 610055
About this study
Official title: A Clinical Trial to Assess the Immunogenicity and Safety Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Adults 18-59 Years of Age Completed Two- or Three-dose Inactivated COVID-19 Vaccine
The goal of this clinical trial is to assess the immunogenicity and safety following a heterologous booster dose of recombinant SARS-CoV-2 vaccine (CHO cell) LYB001 in adults 18-59 years of age completed two- or three-dose inactivated COVID-19 vaccine. The main questions it aims to answer are:
- whether LYB001 group is better on immunogenicity than the control group of inactivated vaccine?
- whether LYB001 group has better performance on safety than the control group of inactivated vaccine, such as the lower adverse reaction rate?
Read the detailed description
Primary Objectives
- To assess the immunogenicity profile following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine.
- To assess the safety profile following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine.
Secondary Objectives 1) To assess the immune durability following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine.
Exploratory objectives
- To assess the cellular immune response following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine.
- Conditions
- COVID-19, Vaccine Reaction
- Being tested
- LYB001, CoronaVac
- Keywords
- Safety, immunogenicity, heterologous booster, inactivated COVID-19 vaccine, recombinant SARS-CoV-2 vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYB001Biological
Experimental: The LYB001 vaccine was administered through intramuscular injection at doses of 30ug or 60ug in a 0.5mL volume.
CoronaVacBiological
Active Comparator: The CoronaVac vaccine was administered through intramuscular injection in a 0.5mL volume.
| Study group | Role | What they receive |
|---|---|---|
| LYB001 | Experimental | Participants receiving a boost with 30ug or 60ug LYB001 after a two-or three-dose primary series of inactivated COVID-19 vaccine. Receives: Biological: LYB001 |
| CoronaVac | Active comparator | Participants receiving a boost with vaccine CoronaVac after a two-or three-dose primary series of inactivated COVID-19 vaccine. Receives: Biological: CoronaVac |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after the booster immunization
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 14 days after the booster immunization will be calculated for each group, respectively.
Measured: 14 days after booster vaccination
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after the booster immunization
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 28 days after the booster immunization will be calculated for each group, respectively.
Measured: 28 days after booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 14 days after the booster immunization will be calculated for each group, respectively.
Measured: 14 days after booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 28 days after the booster immunization will be calculated for each group, respectively.
Measured: 28 days after booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after the booster immunization compared with the baseline
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 14 days after the booster immunization will be calculated for each group, compared with the baseline, respectively.
Measured: 14 days after booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after the booster immunization compared with the baseline
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 28 days after the booster immunization will be calculated for each group, compared with the baseline, respectively.
Measured: 28 days after booster vaccination
The frequencies and percentages of adverse events within 30 minutes after booster vaccination
Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups.
Solicited and unsolicited AEs within 30 mins after vaccination will be collected.
Measured: within 30 minutes after booster vaccination
The frequencies and percentages of adverse events within 7 days after booster vaccination
Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups.
Solicited and unsolicited AEs within 7 days after vaccination will be collected.
Measured: within 7 days after booster vaccination
The frequencies and percentages of unsolicitedadverse events within 8-28 days after booster vaccination
Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups.
Unsolicited AEs within 8-28 days after vaccination will be collected.
Measured: within 8-28 days after booster vaccination
Secondary outcomes (9)
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding at 3 months after booster vaccination
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of NAbs against prototype SARS-CoV-2 and circulating VOCs, S protein-binding antibodies, at 3 months after booster vaccination will be calculated for each group, respectively.
Measured: 3 months after booster vaccination
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding at 6 months after booster vaccination
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of NAbs against prototype SARS-CoV-2 and circulating VOCs, S protein-binding antibodies, at 6 months after booster vaccination will be calculated for each group, respectively.
Measured: 6 months after booster vaccination
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding at 12 months after booster vaccination
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of NAbs against prototype SARS-CoV-2 and circulating VOCs, S protein-binding antibodies, at 12 months after booster vaccination will be calculated for each group, respectively.
Measured: 12 months after booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 3 months after booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs of NAbs against prototype SARS-CoV-2 and circulating VOCs, S protein-binding antibodies, at 3 months after booster vaccination will be calculated for each group, respectively.
Measured: 3 months after booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 6 months after booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs of NAbs against prototype SARS-CoV-2 and circulating VOCs, S protein-binding antibodies, at 6 months after booster vaccination will be calculated for each group, respectively.
Measured: 6 months after booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 12 months after booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs of NAbs against prototype SARS-CoV-2 and circulating VOCs, S protein-binding antibodies, at 12 months after booster vaccination will be calculated for each group, respectively.
Measured: 12 months after booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 3 months after booster vaccination compared with the baseline
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of NAbs against prototype SARS-CoV-2 and circulating VOCs, S protein-binding antibodies, at 3 months after booster vaccination will be calculated for each group, compared with the baseline, respectively.
Measured: 3 months after booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 6 months after booster vaccination compared with the baseline
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of NAbs against prototype SARS-CoV-2 and circulating VOCs, S protein-binding antibodies, at 6 months after booster vaccination will be calculated for each group, compared with the baseline, respectively.
Measured: 6 months after booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 12 months after booster vaccination compared with the baseline
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of NAbs against prototype SARS-CoV-2 and circulating VOCs, S protein-binding antibodies, at 12 months after booster vaccination will be calculated for each group, compared with the baseline, respectively.
Measured: 12 months after booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start14 May 2022
- Primary completion10 Oct 2022
- Study completion30 Jun 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open label, positive control (Stage Ⅰ); Single-arm, open-label (Stage Ⅱ)
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yantai Patronus Biotech Co., Ltd., Affiliated Hospital of North Sichuan Medical College
- Responsible party
- Sponsor
- Investigators
- Xiaolan Yong, Bachelor, Principal investigator, Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College, Chengdu, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928455
- Sponsor's protocol ID
- MLD-C-22001
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Immunogenicity and Safety Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Adults 18-59 Years of Age Completed Two- or Three-dose Inactivated COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05928455
- Acronym / sponsor ID
- MLD-C-22001
- Conditions
- COVID-19, Vaccine Reaction
- Keywords
- Safety, immunogenicity, heterologous booster, inactivated COVID-19 vaccine, recombinant SARS-CoV-2 vaccine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Yantai Patronus Biotech Co., Ltd., Affiliated Hospital of North Sichuan Medical College
- Study start
- 14 May 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 3 Jul 2023 (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.
The goal of this clinical trial is to assess the immunogenicity and safety following a heterologous booster dose of recombinant SARS-CoV-2 vaccine (CHO cell) LYB001 in adults 18-59 years of age completed two- or three-dose inactivated COVID-19 vaccine. The main questions it aims to answer are:
- whether LYB001 group is better on immunogenicity than the control group of inactivated vaccine?
- whether LYB001 group has better performance on safety than the control group of inactivated vaccine, such as the lower adverse reaction rate?
Detailed description
Primary Objectives
- To assess the immunogenicity profile following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine.
- To assess the safety profile following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine.
Secondary Objectives 1) To assess the immune durability following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine.
Exploratory objectives
- To assess the cellular immune response following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open label, positive control (Stage Ⅰ); Single-arm, open-label (Stage Ⅱ)
| Arm | Type | Receives |
|---|---|---|
| LYB001 | Experimental | Biological: LYB001Participants receiving a boost with 30ug or 60ug LYB001 after a two-or three-dose primary series of inactivated COVID-19 vaccine. |
| CoronaVac | Active comparator | Biological: CoronaVacParticipants receiving a boost with vaccine CoronaVac after a two-or three-dose primary series of inactivated COVID-19 vaccine. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects aged 18-59 years, including both males and females;
- Subjects who agree to participate in this clinical trial voluntarily and sign the informed consent form, are capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
- Subjects who have completed two- or three-dose inactivated COVID-19 vaccine at 6-12 months earlier.
- For female participants of childbearing potential, effective contraception measures should be used within 2 weeks prior to participation in this study and the results of pregnancy test is required to be negative. Participants should voluntarily agree to use effective contraceptive measures from the time of signing the informed consent form to the end of the study (effective contraceptive measures including oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).
Key exclusion criteria (21 listed)
- Receipt of any COVID-19 prophylactic medication (e.g., receipt history of any approved or under developing COVID-19 vaccines other than inactivated vaccine), or previous vaccination history other than other than two or three doses of inactivated vaccination;
- Abnormal vital signs with clinical significance prior to enrolment, with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or axillary body temperature ≥ 37.3°C prior to enrolment; abnormal results of laboratory screening tests which was clinically significant judged by clinicians prior to enrolment.
- Known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients;
- History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
- History of COVID-19, or history of close contact with confirmed/suspected COVID-19 patients, or positive results for SARS-CoV-2 nucleic acid tests at screening;
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 |
|---|---|---|
| LYB001Experimental: The LYB001 vaccine was administered through intramuscular injection at doses of 30ug or 60ug in a 0.5mL volume. | Biological | LYB001 |
| CoronaVacActive Comparator: The CoronaVac vaccine was administered through intramuscular injection in a 0.5mL volume. | Biological | CoronaVac |
Primary outcome
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after the booster immunization
Time frame: 14 days after booster vaccination
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 14 days after the booster immunization will be calculated for each group, respectively.
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after the booster immunization
Time frame: 28 days after booster vaccination
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 28 days after the booster immunization will be calculated for each group, respectively.
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after booster vaccination
Time frame: 14 days after booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 14 days after the booster immunization will be calculated for each group, respectively.
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after booster vaccination
Time frame: 28 days after booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 28 days after the booster immunization will be calculated for each group, respectively.
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after the booster immunization compared with the baseline
Time frame: 14 days after booster vaccination
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 14 days after the booster immunization will be calculated for each group, compared with the baseline, respectively.
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after the booster immunization compared with the baseline
Time frame: 28 days after booster vaccination
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 28 days after the booster immunization will be calculated for each group, compared with the baseline, respectively.
The frequencies and percentages of adverse events within 30 minutes after booster vaccination
Time frame: within 30 minutes after booster vaccination
Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups. Solicited and unsolicited AEs within 30 mins after vaccination will be collected.
The frequencies and percentages of adverse events within 7 days after booster vaccination
Time frame: within 7 days after booster vaccination
Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups. Solicited and unsolicited AEs within 7 days after vaccination will be collected.
The frequencies and percentages of unsolicitedadverse events within 8-28 days after booster vaccination
Time frame: within 8-28 days after booster vaccination
Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups. Unsolicited AEs within 8-28 days after vaccination will be collected.
9 secondary outcomes
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding at 3 months after booster vaccination
Time frame: 3 months after booster vaccination
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding at 6 months after booster vaccination
Time frame: 6 months after booster vaccination
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding at 12 months after booster vaccination
Time frame: 12 months after booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 3 months after booster vaccination
Time frame: 3 months after booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 6 months after booster vaccination
Time frame: 6 months after booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 12 months after booster vaccination
Time frame: 12 months after booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 3 months after booster vaccination compared with the baseline
Time frame: 3 months after booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 6 months after booster vaccination compared with the baseline
Time frame: 6 months after booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 12 months after booster vaccination compared with the baseline
Time frame: 12 months after booster vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Xiaolan Yong, Bachelor principal investigator
Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College, Chengdu, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LYB001 and CoronaVac in people with COVID-19 and Vaccine Reaction, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.
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 21 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 3 Jul 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 China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after the booster immunization (time frame: 14 days after booster vaccination). The study lists 9 primary outcomes in all. 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 3 Jul 2023.