SARS-CoV-2Phase 3NCT05428592
Clinical Trial of SARS-CoV-2 mRNA Vaccine(LVRNA009) as Heterologous Booster in Islamabad
A Phase 3 study testing LVRNA009 and CoronaVac® in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. at 1 site in Pakistan.
Trial summary
This study is a randomized, blinded, parallel-controlled phase 3 clinical trial. The study intent to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (LVRNA009) as heterologous booster in participants aged 18 years and older vaccinated 2 doses Inactivated 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?
- LVRNA009 and CoronaVac®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2023to Oct 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 contents of the ICF and voluntarily sign it (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 study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
- Female participants of childbearing potential or partners of male participants: voluntarily agree to use effective contraception with their partners 14 days prior to the vaccination and must agree to continue such precautions during the study until 3 months after vaccination. [Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for males), 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 vaccination in this study.
- Axillary temperature <37.3°C/99.1°F at screening visit and 72 hours prior to vaccination.
- 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 vaccinated 2 doses of CoronaVac® (with an interval of 3-8 weeks between 2 doses), for 6-12 months prior to enrollment.
Who cannot join
- Previous medications intervention for the prophylaxis or prevention of COVID-19 (Including vaccination with any licensed SARS-CoV-2 vaccines other than 2 doses of CoronaVac® ).
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infections.
- History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
- History of allergy to any component of the study vaccine or history of severe allergic reaction to the vaccine or drug (including but not limited to anaphylaxis, allergic laryngeal oedema, anaphylactic purpura, thrombocytopenic purpura, or localized allergic necrosis (Arthus reaction)).
- Positive nucleic acid for SARS-CoV-2 in nasopharyngeal/oropharyngeal swab specimens.
- Positive HIV test result.
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- 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.
- Congenital or functional splenic deficiency, complete or partial splenectomy for any reason.
- Prolonged (defined as more than 14 days) use of immunosuppressive or other immunomodulatory drugs (e.g., corticosteroids, ≥20 mg/d prednisone or equivalent; however, inhaled and topical steroids are permitted) within 6 months prior to the vaccine.
- Any other licensed vaccines given within 28 days prior to the study vaccination, or planned administration of vaccine(s) within 28 days after vaccination.
- Have received immunoglobulin or other blood products within 3 months prior to enrollment or plan to receive them during the study period.
- Blood donation or blood loss ≥ 450 mL within 1 month prior to enrolment, or planned donation during the study period.
- Participants who have received any other investigational product within 1 month prior to enrollment or intent to participate in another clinical study at any time during the conduct of this study.
- Female participants 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
Clinical Trial Unit, National Institute of Health
Islamabad, 45500
Omera Naseer, Dr, 03005302095, omerashuaib@hotmail.com
Aamer Ikram, Dr
About this study
Official title: A Randomized, Blinded, Parallel-controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of SARS-CoV-2 mRNA Vaccine (LVRNA009) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated 2 Doses Inactivated SARS-CoV-2 Vaccine
This study is a randomized, blinded, parallel-controlled phase 3 clinical trial. The study intent to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (LVRNA009) as heterologous booster in participants aged 18 years and older vaccinated 2 doses Inactivated SARS-CoV-2 Vaccine.
- Conditions
- SARS-CoV-2
- Being tested
- LVRNA009, CoronaVac®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVRNA009Biological
50μg /0.5 mL/Vial/person
CoronaVac®Biological
0.5 mL/Vial, 0.5mL per human dose containing 600SU of inactivated SARS-CoV-2 antigen
| Study group | Role | What they receive |
|---|---|---|
| LVRNA009 study group | Experimental | Not described Receives: Biological: LVRNA009 |
| CoronaVac® control group | Active comparator | Not described Receives: Biological: CoronaVac® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Measured: 14 days after vaccination for all participants
Seroconversion Rate (SCR) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Seroconversion is defined as: GMT post vaccination≥ 4-fold rise from baseline GMT value
Measured: 14 days after vaccination for all participants
Incidence of each solicited (local and systemic) AE and each unsolicited AE
Measured: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants
Intensity of each solicited (local and systemic) AE and each unsolicited AE
Measured: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants
Duration of each solicited (local and systemic) AE and each unsolicited AE
Measured: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants
Secondary outcomes (13)
Geometric mean increase (GMI) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Measured: 14 days after vaccination for all participants
GMT of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Measured: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
SCR of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Measured: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMI of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Measured: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMT of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay)
Measured: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
SCR of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay)
Measured: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMI of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay)
Measured: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMT of S-protein specific IgG antibodies (ELISA)
Measured: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
SCR of S-protein specific IgG antibodies (ELISA)
Measured: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMI of S-protein specific IgG antibodies (ELISA)
Measured: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
Incidence of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events
Measured: within 12 months after vaccination for all participants
Intensity of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events
Measured: within 12 months after vaccination for all participants
Causality of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events
Measured: within 12 months after vaccination for all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study startApr 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 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
- Model description
- A randomized, blinded, parallel-controlled design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIM Vaccine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aamer Ikram, Principal investigator, National Institute of Health, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428592
- Sponsor's protocol ID
- LVRNA009-Ⅲ-02
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Parallel-controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of SARS-CoV-2 mRNA Vaccine (LVRNA009) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated 2 Doses Inactivated SARS-CoV-2 Vaccine
- ClinicalTrials.gov ID
- NCT05428592
- Acronym / sponsor ID
- LVRNA009-Ⅲ-02
- Conditions
- SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- AIM Vaccine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 23 Jun 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 study is a randomized, blinded, parallel-controlled phase 3 clinical trial. The study intent to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (LVRNA009) as heterologous booster in participants aged 18 years and older vaccinated 2 doses Inactivated SARS-CoV-2 Vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, blinded, parallel-controlled design
| Arm | Type | Receives |
|---|---|---|
| LVRNA009 study group | Experimental | Biological: LVRNA009 |
| CoronaVac® control group | Active comparator | Biological: CoronaVac® |
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 contents of the ICF and voluntarily sign it (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 study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
- Female participants of childbearing potential or partners of male participants: voluntarily agree to use effective contraception with their partners 14 days prior to the vaccination and must agree to continue such precautions during the study until 3 months after vaccination. [Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for males), 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 vaccination in this study.
Key exclusion criteria (16 listed)
- Previous medications intervention for the prophylaxis or prevention of COVID-19 (Including vaccination with any licensed SARS-CoV-2 vaccines other than 2 doses of CoronaVac® ).
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infections.
- History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
- History of allergy to any component of the study vaccine or history of severe allergic reaction to the vaccine or drug (including but not limited to anaphylaxis, allergic laryngeal oedema, anaphylactic purpura, thrombocytopenic purpura, or localized allergic necrosis (Arthus reaction)).
- Positive nucleic acid for SARS-CoV-2 in nasopharyngeal/oropharyngeal swab specimens.
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 |
|---|---|---|
| LVRNA00950μg /0.5 mL/Vial/person | Biological | LVRNA009 study group |
| CoronaVac®0.5 mL/Vial, 0.5mL per human dose containing 600SU of inactivated SARS-CoV-2 antigen | Biological | CoronaVac® control group |
Primary outcome
Geometric mean titer (GMT) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 14 days after vaccination for all participants
Seroconversion Rate (SCR) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 14 days after vaccination for all participants
Seroconversion is defined as: GMT post vaccination≥ 4-fold rise from baseline GMT value
Incidence of each solicited (local and systemic) AE and each unsolicited AE
Time frame: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants
Intensity of each solicited (local and systemic) AE and each unsolicited AE
Time frame: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants
Duration of each solicited (local and systemic) AE and each unsolicited AE
Time frame: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants
13 secondary outcomes
Geometric mean increase (GMI) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 14 days after vaccination for all participants
GMT of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
SCR of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMI of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMT of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
SCR of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMI of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMT of S-protein specific IgG antibodies (ELISA)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
SCR of S-protein specific IgG antibodies (ELISA)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMI of S-protein specific IgG antibodies (ELISA)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
Incidence of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events
Time frame: within 12 months after vaccination for all participants
Intensity of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events
Time frame: within 12 months after vaccination for all participants
Causality of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events
Time frame: within 12 months after vaccination for all participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
Aamer Ikram principal investigator
National Institute of Health, Islamabad
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 LVRNA009 and CoronaVac® 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 16 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 2 Feb 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. 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 Fan Zhang (021-33360772 ext. 8066, fan.zhang@aimbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer (GMT) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) (time frame: 14 days after vaccination for all participants). The study lists 5 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 2 Feb 2023.