SARS-CoV-2Phase 2NCT05939648
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021)
A Phase 2 study testing SARS-CoV-2 Bivalent mRNA Vaccine and Saline in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. at 1 site in China.
Trial summary
This trial is a phase II clinical trial of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). The trial was randomized, blinded, placebo controlled. To evaluate the safety and immunogenicity of the study vaccine in participants aged 18 years and older who have received SARS-CoV-2 Vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- SARS-CoV-2 Bivalent mRNA Vaccine and Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2023to 30 Dec 2024
- Phase
- Phase 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
- Healthy adults aged 18 years and older, both male and female, who can provide legal identity certificate of participants;
- The subject understands the contents of the Informed Consent Form and the vaccination situation of this vaccination, voluntarily signs the Informed Consent Form, and has the ability to use the thermometer, scale and fill in the Diary Card and Contact Card as required (if the subject is unable to sign the Informed Consent Form by himself/herself due to limited reading and writing ability, the informed consent form and signature of the Informed Consent Form can be completed under the witness' s witness);
- Able to communicate well with investigators and understand and comply with the requirements of this trial;
- Completion of basic immunization with SARS-CoV-2 vaccine ≥ 6 months;
- Negative nucleic acid test for SARS-CoV-2 within 3 days prior to vaccination;
- Women who have used effective contraception within 2 weeks prior to inclusion in this trial, have a negative pregnancy test (pregnancy test can be exempted for those who have been amenorrheic for at least 1 year or have a documented history of surgical sterilization), and voluntarily agree to continue using at least 1 effective contraception within 6 months after vaccination [effective contraception includes: oral contraceptives, injected or implanted contraception, sustained-release local contraceptives, hormonal patches, intrauterine device (IUD), sterilization, abstinence, condoms (men), diaphragms, cervical caps, etc.];
- Healthy participants or participants with mild underlying disease [stable condition without worsening (requiring no hospitalization or major modification of treatment regimen, etc.) for at least 3 months prior to inclusion in this trial].
Who cannot join
- Participants with abnormal electrocardiogram during screening and who were judged unsuitable for vaccination by investigators; Blood pressure indicators during the screening period: systolic blood pressure ≥160 or diastolic blood pressure ≥100mmHgHg, or abnormal blood pressure, and the health status determined by the investigator is uncertain and requires further diagnosis, or the investigator determines that the vaccination is not suitable for participants with medical history and clinical manifestations ;
- Body mass index (BMI) <18 kg/m 2 or >30 kg/m 2;
- Individuals with any infectious disease, acute infection, acute phase of chronic infection (such as active untreated pulmonary tuberculosis, etc.) or any advanced immune disease (inquiry);
- Infected within last 6 months or likely infected with SARS-CoV-2;
- Positive HIV test result at screening;
- Fever on the day of investigational vaccination (axillary temperature ≥ 37.3℃) or within 3 days, or use of antipyretic and analgesic drugs within 3 days;
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- Women with a positive pregnancy test (surgical sterilizers who are menstruating or amenorrheic for at least 1 year or have medical records may be exempted from pregnancy testing), or breastfeeding women, or women planning to become pregnant from screening through 6 months after booster vaccination, men whose partners plan to become pregnant, or plan to donate sperm and eggs;
- Previous history of allergic or allergic reactions to vaccines or drugs, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.;
- Administration of any vaccine within 28 days prior to booster vaccination with investigational vaccine;
- Have participated within 28 days prior to booster vaccination with investigational vaccine or plan to participate in other drug clinical trials within 12 months after booster vaccination;
- Patients with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous blood sampling or injection, and patients with a history of thrombosis;
- Known history or diagnosis of diseases affecting immune system function, such as cancer (except basal cell carcinoma of the skin), congenital or acquired immunodeficiency, uncontrolled autoimmune diseases, etc. (such as systemic lupus erythematosus, autoimmune thyroid disease, multiple sclerosis);
- Absence of spleen or functional absence of spleen;
- Chronic use (≥14 consecutive days) of immunosuppressants or other immunomodulatory drugs (eg, corticosteroids: prednisone or drugs of the same class) within 6 months prior to booster vaccination with the investigational vaccine, but topical medications (eg, ointments, eye drops, inhalers, or nasal sprays) are allowed and should not exceed the dose recommended in the package insert;
- Immunoglobulins and/or blood products received within 3 months prior to the investigational booster vaccination;
- Suspected or known alcohol dependence or drug abuse that could compromise the safety evaluation or subject compliance;
- Other conditions that the investigator considers inappropriate for participation in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Blinded, Positive and Placebo-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) Booster Vaccination in People 18 Years of Age and Older Who Have Received SARS-CoV-2 Vaccine.
This trial is a phase II clinical trial of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). The trial was randomized, blinded, placebo controlled. To evaluate the safety and immunogenicity of the study vaccine in participants aged 18 years and older who have received SARS-CoV-2 Vaccine.
- Conditions
- SARS-CoV-2
- Being tested
- SARS-CoV-2 Bivalent mRNA Vaccine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Bivalent mRNA VaccineBiological
Also called LVRNA021
100 μg /1.0 mL/dose, slightly milky white and clear liquid, intramuscular injection into the lateral deltoid muscle of the upper arm.
SalineOther
100 μg /1.0 mL/dose, intramuscular injection into the lateral deltoid muscle of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Bivalent mRNA Vaccine | Experimental | 100 μg /1.0 mL/dose, One booster dose 1.0mL IM injection of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). Receives: Biological: SARS-CoV-2 Bivalent mRNA Vaccine |
| Saline | Placebo comparator | One booster dose 1.0mL IM injection of saline. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT and SCR of live virus neutralizing antibodys against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
GMT and SCR of live virus neutralizing antibodys against SARS-CoV-2 ( Delta strain, Omicron BA.5, XBB strains and current major circulating strains) on day 14 after vaccination.
Measured: 14 day after booster vaccination.
Incidence of solicited and unsolicited adverse events
Incidence of solicited and unsolicited adverse events within 0-28 days after booster vaccination.
Measured: 0-28 days after booster vaccination.
Secondary outcomes (6)
Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs).
Incidence of SAEs and AESIs through 12 months after booster vaccination in all subjects.
Measured: 12 months after booster vaccination
GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains) on day 14 after booster vaccination.
Measured: 14 day after booster vaccination.
GMT, SCR, GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
GMT, SCR, GMI of live virus neutralizing antibodies against SARS-CoV-2 ( Delta strain, Omicron BA.5, XBB strains and current major circulating strains) on days 7 and 28 after booster vaccination.
Measured: 7, 28 days after booster vaccination.
GMT of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
GMT of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains) at 3, 6, 12 months after booster vaccination.
Measured: 3, 6, 12 months after booster vaccination.
GMC, SCR, GMI of IgG antibodies against S proteins of SARS-CoV-2 ( Delta strain, Omicron BA.5)
GMC, SCR, GMI of IgG antibodies against S proteins of SARS-CoV-2 ( Delta strain, Omicron BA.5) on days 7, 14, and 28 after booster vaccination.
Measured: 7, 14, 28 days after booster vaccination.
GMC of antibodies against S proteins of SARS-CoV-2 (Delta strain, Omicron BA.5)
GMC of antibodies against S proteins of SARS-CoV-2 (Delta strain, Omicron BA.5) at 3 months, 6 months and 12 months after booster vaccination.
Measured: 3, 6, 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 posted11 Jul 2023
- Study start9 Oct 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIM Vaccine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ningbo Rongan Biological Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Fan Zhang, Study director, AIM Vaccine Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939648
- Sponsor's protocol ID
- LVRNA021-II-01
- Status last verified
- Nov 2023
- First submitted
- 7 Jul 2023
- Last updated
- 24 Nov 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Positive and Placebo-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) Booster Vaccination in People 18 Years of Age and Older Who Have Received SARS-CoV-2 Vaccine.
- ClinicalTrials.gov ID
- NCT05939648
- Acronym / sponsor ID
- LVRNA021-II-01
- Conditions
- SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (actual)
- Lead sponsor
- AIM Vaccine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ningbo Rongan Biological Pharmaceutical Co., Ltd.
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 11 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.
This trial is a phase II clinical trial of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). The trial was randomized, blinded, placebo controlled. To evaluate the safety and immunogenicity of the study vaccine in participants aged 18 years and older who have received SARS-CoV-2 Vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Bivalent mRNA Vaccine | Experimental | Biological: SARS-CoV-2 Bivalent mRNA Vaccine100 μg /1.0 mL/dose, One booster dose 1.0mL IM injection of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). |
| Saline | Placebo comparator | Other: SalineOne booster dose 1.0mL IM injection of saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy adults aged 18 years and older, both male and female, who can provide legal identity certificate of participants;
- The subject understands the contents of the Informed Consent Form and the vaccination situation of this vaccination, voluntarily signs the Informed Consent Form, and has the ability to use the thermometer, scale and fill in the Diary Card and Contact Card as required (if the subject is unable to sign the Informed Consent Form by himself/herself due to limited reading and writing ability, the informed consent form and signature of the Informed Consent Form can be completed under the witness' s witness);
- Able to communicate well with investigators and understand and comply with the requirements of this trial;
- Completion of basic immunization with SARS-CoV-2 vaccine ≥ 6 months;
- Negative nucleic acid test for SARS-CoV-2 within 3 days prior to vaccination;
Key exclusion criteria (17 listed)
- Participants with abnormal electrocardiogram during screening and who were judged unsuitable for vaccination by investigators; Blood pressure indicators during the screening period: systolic blood pressure ≥160 or diastolic blood pressure ≥100mmHgHg, or abnormal blood pressure, and the health status determined by the investigator is uncertain and requires further diagnosis, or the investigator determines that the vaccination is not suitable for participants with medical history and clinical manifestations ;
- Body mass index (BMI) <18 kg/m 2 or >30 kg/m 2;
- Individuals with any infectious disease, acute infection, acute phase of chronic infection (such as active untreated pulmonary tuberculosis, etc.) or any advanced immune disease (inquiry);
- Infected within last 6 months or likely infected with SARS-CoV-2;
- Positive HIV test result 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 |
|---|---|---|
| SARS-CoV-2 Bivalent mRNA VaccineAlso: LVRNA021100 μg /1.0 mL/dose, slightly milky white and clear liquid, intramuscular injection into the lateral deltoid muscle of the upper arm. | Biological | SARS-CoV-2 Bivalent mRNA Vaccine |
| Saline100 μg /1.0 mL/dose, intramuscular injection into the lateral deltoid muscle of the upper arm. | Other | Saline |
Primary outcome
GMT and SCR of live virus neutralizing antibodys against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
Time frame: 14 day after booster vaccination.
GMT and SCR of live virus neutralizing antibodys against SARS-CoV-2 ( Delta strain, Omicron BA.5, XBB strains and current major circulating strains) on day 14 after vaccination.
Incidence of solicited and unsolicited adverse events
Time frame: 0-28 days after booster vaccination.
Incidence of solicited and unsolicited adverse events within 0-28 days after booster vaccination.
6 secondary outcomes
Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs).
Time frame: 12 months after booster vaccination
GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
Time frame: 14 day after booster vaccination.
GMT, SCR, GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
Time frame: 7, 28 days after booster vaccination.
GMT of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
Time frame: 3, 6, 12 months after booster vaccination.
GMC, SCR, GMI of IgG antibodies against S proteins of SARS-CoV-2 ( Delta strain, Omicron BA.5)
Time frame: 7, 14, 28 days after booster vaccination.
GMC of antibodies against S proteins of SARS-CoV-2 (Delta strain, Omicron BA.5)
Time frame: 3, 6, 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 24 Nov 2023.
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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.
Fan Zhang study director
AIM Vaccine Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SARS-CoV-2 Bivalent mRNA Vaccine and Saline in people with SARS-CoV-2, run by AIM Vaccine 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 7 inclusion and 17 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 24 Nov 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. 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 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?
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?
GMT and SCR of live virus neutralizing antibodys against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains). (time frame: 14 day after booster vaccination.). 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?
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 24 Nov 2023.