SARS-CoV-2Phase 3NCT05812014
Clinical Trail of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) in Participants Aged 18 Years and Older
A Phase 3 study testing SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021) and 0.9% sodium chloride solution in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. at 1 site in Pakistan.
Trial summary
This is a multi-center, randomized, blinded, placebo-controlled, phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) as booster in participants aged 18 years and older who completed primary/1 booster dose(s) of SARS-CoV-2 vaccination. 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 (LVRNA021) and 0.9% sodium chloride solution
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,800 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Mar 2023to Jun 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
- Adults aged 18 years and older;
- Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to illiteracy, an impartial witness is needed);
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures;
- Female participants of childbearing potential or partners of male participants: voluntarily agree to use effective contraception with their partners prior to the first vaccination and must agree to continue such precautions during the study until 3 months after booster vaccination [Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for male), diaphragms, cervical caps, etc.);
- For female participants: without childbearing potential (amenorrhea for at least 1 year or documented surgical sterilization) or have used effective contraception with a negative pregnancy test before booster vaccination in this study；
- On the day of vaccination and 24 hours prior to vaccination, axillary temperatures<37.3°C/99.1°F;
- Healthy participants or participants with mild underlying disease [in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study];
- Participants who have received primary/1 booster dose(s) of SARS-CoV-2 vaccination (including primary series of inactivated vaccine, mRNA vaccine, adenovirus vaccine or 1 homologous/heterologous booster), with the last dose received at least 6 months before enrolment. Documented confirmation of prior SARS-CoV-2 vaccination receipt must be obtained prior to randomization;
Who cannot join
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections at any time;
- History of hepatitis A, hepatitis B, hepatitis C, syphilis infection based on medical inquiry.;
- History of severe adverse reaction associated with a vaccine or drug and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s);
- Receipt of medications intended to treat COVID-19 within 6 months;
- Virologically confirmed SARS-CoV-2 diagnosis within 6 months before screening visit;
- Positive nasopharyngeal/oropharyngeal swab SARS-CoV-2 RT-PCR test result at screening;
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- Positive HIV test result at screening;
- A history or family history of convulsions, epilepsy, encephalopathy and psychosis;
- Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period;
- Asplenia or functional asplenia, complete or partial splenectomy from any cause;
- Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, epidural, or topical (skin or eyes) corticosteroids are permitted;
- Any other licensed vaccines given within 28 days prior to vaccination, planned administration of any other vaccines within 28 days after vaccination, or planned administration of other COVID-19 vaccines during the entire study duration;
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before vaccine administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before vaccine administration, or planned receipt throughout the study;
- Blood donation or blood loss ≥ 450 mL within 1 month prior to enrollment or planned to donate blood during the study period;
- Participation in other studies involving study intervention within 28 days prior to study entry, and/or during the study;
- Women who are pregnant or breastfeeding;
- Participants deemed unsuitable for participation in this study based on the investigator's assessment.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Sindh Infectious Diseases Hospital & Research Center Dow University of Health Sciences
Islamabad, 9216793
Muneeba Ahsan Sayeed, PHD
About this study
Official title: A Multi-center, Randomized, Blinded, Placebo-controlled, Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) as Booster in Participants Aged 18 Years and Older Who Completed Primary/1 Booster Dose(s) of SARS-CoV-2 Vaccination
This is a multi-center, randomized, blinded, placebo-controlled, phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) as booster in participants aged 18 years and older who completed primary/1 booster dose(s) of SARS-CoV-2 vaccination.
- Conditions
- SARS-CoV-2
- Being tested
- SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021), 0.9% sodium chloride solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021)Biological
One dose was administered by intramuscular injection, 100μg，1.0ml/dose
0.9% sodium chloride solutionDrug
One dose was administered by intramuscular injection, 1.0ml/dose
| Study group | Role | What they receive |
|---|---|---|
| Study Vaccine Group | Experimental | Not described Receives: Biological: SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021) |
| Control Group | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis occurring from 14 days after booster vaccination.
Measured: 14 days after vaccination or placebo
Secondary outcomes (23)
Person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19
The person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19 from 14 days after booster vaccination meeting the case definition for the primary efficacy analysis.
Measured: 14 days after vaccination or placebo
Person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 from 14 days after booster vaccination meeting the case definition for the primary efficacy analysis.
Measured: 14 days after vaccination or placebo
Person-year incidence density of first episodes of virologically-confirmed cases of COVID-19
The person-year incidence density of first episodes of virologically-confirmed cases of COVID-19 leading to death from 14 days after booster vaccination meeting the case definition for the primary efficacy analysis.
Measured: 14 days after vaccination or placebo
Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 for participants in different age strata (18-59 years, ≥ 60 years)
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring from 14 days after booster vaccination for participants in different age strata (18-59 years, ≥ 60 years).
Measured: 14 days after vaccination or placebo
Incidence of each solicited (local and systemic) AE in all participants.
Incidence of each solicited (local and systemic) AE within 14 days after booster vaccination in all participants.
Measured: within 14 days after vaccination or placebo
Severity of each solicited (local and systemic) AE in all participants.
Severity of each solicited (local and systemic) AE within 14 days after booster vaccination in all participants.
Measured: within 14 days after vaccination or placebo
Duration of each solicited (local and systemic) AE in all participants.
Duration of each solicited (local and systemic) AE within 14 days after booster vaccination in all participants.
Measured: within 14 days after vaccination or placebo
Incidence of unsolicited AEs in all participants.
Incidence of unsolicited AEs occurring 0-28 days after booster vaccination in all participants.
Measured: 0-28 days after vaccination or placebo
Severity of unsolicited AEs in all participants.
Severity of unsolicited AEs occurring 0-28 days after booster vaccination in all participants.
Measured: 0-28 days after vaccination or placebo
Causality of unsolicited AEs in all participants.
Causality of unsolicited AEs occurring 0-28 days after booster vaccination in all participants.
Measured: 0-28 days after vaccination or placebo
Incidence of SAEs in all participants.
Incidence of SAEs from the day of booster vaccination to 12 months after booster vaccination in all participants.
Measured: within 12 months after vaccination or placebo
Severity of SAEs in all participants.
Severity of SAEs from the day of booster vaccination to 12 months after booster vaccination in all participants.
Measured: within 12 months after vaccination or placebo
Incidence of AESIs in all participants.
Incidence of AESIs from the day of booster vaccination to 12 months after booster vaccination in all participants.
Measured: within 12 months after vaccination or placebo
Severity of AESIs in all participants.
Severity of AESIs from the day of booster vaccination to 12 months after booster vaccination in all participants.
Measured: within 12 months after vaccination or placebo
Incidence of pregnancy events in all participants.
Incidence of pregnancy events from the day of booster vaccination to 12 months after booster vaccination in all participants.
Measured: within 12 months after vaccination or placebo
Severity of pregnancy events in all participants.
Severity of pregnancy events from the day of booster vaccination to 12 months after booster vaccination in all participants.
Measured: within 12 months after vaccination or placebo
Causality of SAEs, AESIs, and pregnancy events in all participants.
Causality of SAEs, AESIs, and pregnancy events from the day of booster vaccination to 12 months after booster vaccination in all participants.
Measured: within 12 months after vaccination or placebo
Geometric mean titer (GMT)of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.
Measured: 14 days,28 days,3 months and 6 months after vaccination or placebo
Seroconversion rate (SCR) of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.
Measured: 14 days,28 days,3 months and 6 months after vaccination or placebo
Geometric mean Increase (GMI) of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.
Measured: 14 days,28 days,3 months and 6 months after vaccination or placebo
GMT of S-protein IgG antibodies in subjects in the immunization subgroup.
Measured: 14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo
GMI of S-protein IgG antibodies in subjects in the immunization subgroup.
Measured: 14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo
SCR of S-protein IgG antibodies in subjects in the immunization subgroup.
Measured: 14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start25 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionJun 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIM Vaccine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LiveRNA Therapeutics Inc., 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
- NCT05812014
- Sponsor's protocol ID
- LVRNA021-III-01
- Status last verified
- Jan 2023
- First submitted
- 10 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Blinded, Placebo-controlled, Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) as Booster in Participants Aged 18 Years and Older Who Completed Primary/1 Booster Dose(s) of SARS-CoV-2 Vaccination
- ClinicalTrials.gov ID
- NCT05812014
- Acronym / sponsor ID
- LVRNA021-III-01
- Conditions
- SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9,800 participants (estimated)
- Lead sponsor
- AIM Vaccine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- LiveRNA Therapeutics Inc., Ningbo Rongan Biological Pharmaceutical Co., Ltd.
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 Apr 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 is a multi-center, randomized, blinded, placebo-controlled, phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) as booster in participants aged 18 years and older who completed primary/1 booster dose(s) of SARS-CoV-2 vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Vaccine Group | Experimental | Biological: SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021) |
| Control Group | Placebo comparator | Drug: 0.9% sodium chloride solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years and older;
- Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to illiteracy, an impartial witness is needed);
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures;
- Female participants of childbearing potential or partners of male participants: voluntarily agree to use effective contraception with their partners prior to the first vaccination and must agree to continue such precautions during the study until 3 months after booster vaccination [Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for male), diaphragms, cervical caps, etc.);
- For female participants: without childbearing potential (amenorrhea for at least 1 year or documented surgical sterilization) or have used effective contraception with a negative pregnancy test before booster vaccination in this study；
Key exclusion criteria (17 listed)
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections at any time;
- History of hepatitis A, hepatitis B, hepatitis C, syphilis infection based on medical inquiry.;
- History of severe adverse reaction associated with a vaccine or drug and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s);
- Receipt of medications intended to treat COVID-19 within 6 months;
- Virologically confirmed SARS-CoV-2 diagnosis within 6 months before screening visit;
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 vaccine (LVRNA021)One dose was administered by intramuscular injection, 100μg，1.0ml/dose | Biological | Study Vaccine Group |
| 0.9% sodium chloride solutionOne dose was administered by intramuscular injection, 1.0ml/dose | Drug | Control Group |
Primary outcome
Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19
Time frame: 14 days after vaccination or placebo
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis occurring from 14 days after booster vaccination.
23 secondary outcomes
Person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19
Time frame: 14 days after vaccination or placebo
Person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19
Time frame: 14 days after vaccination or placebo
Person-year incidence density of first episodes of virologically-confirmed cases of COVID-19
Time frame: 14 days after vaccination or placebo
Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 for participants in different age strata (18-59 years, ≥ 60 years)
Time frame: 14 days after vaccination or placebo
Incidence of each solicited (local and systemic) AE in all participants.
Time frame: within 14 days after vaccination or placebo
Severity of each solicited (local and systemic) AE in all participants.
Time frame: within 14 days after vaccination or placebo
Duration of each solicited (local and systemic) AE in all participants.
Time frame: within 14 days after vaccination or placebo
Incidence of unsolicited AEs in all participants.
Time frame: 0-28 days after vaccination or placebo
Severity of unsolicited AEs in all participants.
Time frame: 0-28 days after vaccination or placebo
Causality of unsolicited AEs in all participants.
Time frame: 0-28 days after vaccination or placebo
Incidence of SAEs in all participants.
Time frame: within 12 months after vaccination or placebo
Severity of SAEs in all participants.
Time frame: within 12 months after vaccination or placebo
Incidence of AESIs in all participants.
Time frame: within 12 months after vaccination or placebo
Severity of AESIs in all participants.
Time frame: within 12 months after vaccination or placebo
Incidence of pregnancy events in all participants.
Time frame: within 12 months after vaccination or placebo
Severity of pregnancy events in all participants.
Time frame: within 12 months after vaccination or placebo
Causality of SAEs, AESIs, and pregnancy events in all participants.
Time frame: within 12 months after vaccination or placebo
Geometric mean titer (GMT)of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.
Time frame: 14 days,28 days,3 months and 6 months after vaccination or placebo
Seroconversion rate (SCR) of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.
Time frame: 14 days,28 days,3 months and 6 months after vaccination or placebo
Geometric mean Increase (GMI) of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.
Time frame: 14 days,28 days,3 months and 6 months after vaccination or placebo
GMT of S-protein IgG antibodies in subjects in the immunization subgroup.
Time frame: 14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo
GMI of S-protein IgG antibodies in subjects in the immunization subgroup.
Time frame: 14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo
SCR of S-protein IgG antibodies in subjects in the immunization subgroup.
Time frame: 14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 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 3 study testing SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021) and 0.9% sodium chloride solution in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. at 1 site in Pakistan.
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 8 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 19 Apr 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 Pakistan. 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?
Contact Xinhui Chen (021-3336 ext. 0772, xinhui.chen@aimbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 (time frame: 14 days after vaccination or placebo). 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 19 Apr 2023.