ImmunogenicityPhase 3NCT05580159
New Generation mRNA Booster Vaccine Against Emerging VOCs
A Phase 3 study testing SW-BIC-213 and SARS-Cov-2 Vaccina(Vero Cell ) Inactivated in people with Immunogenicity and Efficacy, run by Stemirna Therapeutics at 1 site in Laos.
Trial summary
Primary：Objectives ：SafetyTo describe the safetyprofile of all participants in each group up to 6months post-dose.Immunogenicity：To demonstrate the superiorityof neutralizing antibodyresponse in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine28 days post dose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunogenicity, Efficacy, Safety
- What is being tested?
- SW-BIC-213 and SARS-Cov-2 Vaccina(Vero Cell ) Inactivated
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteLaos
- Study dates
- Oct 2022to 11 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give written informed consent for participation in the study.
- Male or Female, aged 18 years or above and in good health as determined by study clinician.
- Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunization continuously until 3 months after boost immunization.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Subjects had completed the 2-dose series vaccination of COVID-19 inactivated vaccine at least .
- 24 weeks with the completed the 2-dose Series as the primary vaccination according to the product label.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
- Self-reported history of SARS and MERS infection;
- Receipt of live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination;
- Receipt of any SARS-COV-2 vaccine after last dose of primary vaccination
- Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination.
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- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of study vaccines.
- Any history of anaphylaxis to any component of vaccine.
- Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or continuous use of anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Suspected or known current alcohol or drug dependency
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
- Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness (mild/moderate well controlled comorbidities are allowed).
- Scheduled elective surgery during the trial.
Trial locations and contacts
1 site in 1 country.
Laos1 site, 1 recruiting
- Recruiting
Savannakhét Provincial hospital
Savannakhet, Sava
bin luo, bachelor, +856 02095779465, bin.luo@stemirna.com
hengyu dai, bachelor, +856 02099984604, hengyu.dai@stemirna.com
About this study
Official title: A Multi-national, Randomized, Observer-blinded, Parallel Controlled Trial to Evaluate the Immunogenicity and Safety of New Generation COVID-19 mRNA Booster Vaccination Against Emerging Variants of Concern (VOC)
Primary：Objectives ：SafetyTo describe the safetyprofile of all participants in each group up to 6months post-dose.Immunogenicity：To demonstrate the superiorityof neutralizing antibodyresponse in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine28 days post dose. Secondary:Immunogenicity
- To describe binding antibodyprofile at D01,D08, D15, D29,D91 and D181 of eachstudy group.
- To describe the neutralizing antibody profile atD08,D15,D91 and D181of 600 participants for each studyintervention group. Exploratory:Cell-mediated immunity To describe the cellular immuneresponse profile at D01, D08, D15and D29, in a subset of 30 participants for each study group.
Efficacy:To describe the occurrence of virologically-confirmed COVID-19 like illness and serologically confirmed SARS-CoV-2 infection.
Read the detailed description
Endpoints:Safety Endpoints- Occurrence of unsolicited systemic AEs reported in the 30 minutes after each injection.
Occurrence of solicited injection site reactions and systemicreactions occurring up to 7 days post-dose.
Occurrence of unsolicited non-serious AEs reported up to 28 dayspost-dose. Occurrence of SAEs and AESIs up to 6 months throughout the study. Immunogenicity Endpoints:GMT of neutralizing antibody will be measured with the neutralization assayon D01,D29.
Binding antibody titers to full length SARS-CoV-2 Spike (S) protein will be measured for each study intervention group with the ELISA method
- Antibody titer on D01, D08, D15, D29, D91, D181
- Fold-rise in antibody titer at D08, D15, D29, D91 and D181 post vaccination relative to D01
- 4-fold-rise in antibody titer at D08, D15, D29, D91, and D181 relative to D01 Neutralizing antibody titers will be measured with the neutralization assay
- Antibody titer on D08, D15, D29, D91 and D181
- Fold-rise (fold rise in serum neutralization titer post vaccination relative to D01) at D08, D15, D29, D91 and D181
- 4-fold rise in serum neutralization titer [post/pre] relative to D01 at D08, D15, D29, D91 and D181
- Occurrence of neutralizing antibody seroconversion, defined as baseline values below LLOQ at baseline with detectable neutralization titer above assay lower limit of quantification at D08, D15, D29, D91 and D181INF-γ, IL-4 and IL-2 will be measured in whole blood and/or cryopreserved PBMC following stimulation with pools of S
- ExploratoryCell-mediated immunity To describe the cellular immune response profile at D01, D08, D15 and D29, in a subset of 30 participants for each study group antigen peptides.
Virologically-confirmed COVID 19 like illness as defined by specified clinical symptoms and signs and confirmed by a positive result for SARS-CoV-2 nucleic acid viral detection assay.
- Conditions
- Immunogenicity, Efficacy, Safety
- Being tested
- SW-BIC-213, SARS-Cov-2 Vaccina(Vero Cell ) Inactivated
- Keywords
- new generation mRNA vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SW-BIC-213Biological
The patient will take a single 25 μg dose mRNA vaccine SW-BIC-213.
SARS-Cov-2 Vaccina(Vero Cell ) InactivatedBiological
The patient will take a third dose of COVID-19 Inactivated vaccine.
| Study group | Role | What they receive |
|---|---|---|
| SW-BIC-213 | Experimental | Intervention Name :COVID-19 mRNA vaccine Type :Investigational Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.5ml; Dosage Level(s) :0.25ml; Route of Administration: injection Intramuscular Receives: Biological: SW-BIC-213 |
| SARS-Cov-2 Vaccina(Vero Cell ) Inactivated | Active comparator | Intervention Name: COVID-19 Inactivated Vaccine Type : Control Vaccine Dose :Inactive Unit Dose Strength(s) : 0.5ml; Route of Administration Intramuscular : injection Intramuscular Receives: Biological: SARS-Cov-2 Vaccina(Vero Cell ) Inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To describe the safety profile of all participants in each group up to 6 months post-dose.
Measured: 6 months post-dose
Immunogenicity of 28 days post dose
To demonstrate the superiority of neutralizing antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine 28 days post dose.
Measured: 28 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study startOct 2022 (estimated)
- Primary completion11 May 2023 (estimated)
- Study completion11 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunogenicityStudies 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 observer-blinded parallel controlled trial：Experimental group（mRNA vaccine） and positive control group（inactive vaccine）
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemirna Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayfong Mayxay, doctor, Principal investigator, National Ethics Committee for Health Research(NECHR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580159
- Sponsor's protocol ID
- SWC310
- Status last verified
- Apr 2023
- First submitted
- 8 Oct 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fang Y, Li JX, Duangdany D, Li Y, Guo XL, Phamisith C, Yu B, Shen MY, Luo B, Wang YZ, Liu SJ, Zhao FF, Xu CC, Qiu XH, Yan R, Gui YZ, Pei RJ, Wang J, Shen H, Guan WX, Li HW, Mayxay M. Safety, immunogenicity, and efficacy of a modified COVID-19 mRNA vaccine, SW-BIC-213, in healthy people aged 18 years and above: a phase 3 double-blinded, randomized, parallel controlled clinical trial in Lao PDR (Laos). EClinicalMedicine. 2023 Dec 13;67:102372. doi: 10.1016/j.eclinm.2023.102372. eCollection 2024 Jan.
PubMed 38169790
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-national, Randomized, Observer-blinded, Parallel Controlled Trial to Evaluate the Immunogenicity and Safety of New Generation COVID-19 mRNA Booster Vaccination Against Emerging Variants of Concern (VOC)
- ClinicalTrials.gov ID
- NCT05580159
- Acronym / sponsor ID
- SWC310
- Conditions
- Immunogenicity, Efficacy, Safety
- Keywords
- new generation mRNA vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Stemirna TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2022 (estimated)
- Primary completion
- 11 May 2023 (estimated)
- Study completion
- 11 May 2023 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary：Objectives ：SafetyTo describe the safetyprofile of all participants in each group up to 6months post-dose.Immunogenicity：To demonstrate the superiorityof neutralizing antibodyresponse in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine28 days post dose. Secondary:Immunogenicity
- To describe binding antibodyprofile at D01,D08, D15, D29,D91 and D181 of eachstudy group.
- To describe the neutralizing antibody profile atD08,D15,D91 and D181of 600 participants for each studyintervention group. Exploratory:Cell-mediated immunity To describe the cellular immuneresponse profile at D01, D08, D15and D29, in a subset of 30 participants for each study group.
Efficacy:To describe the occurrence of virologically-confirmed COVID-19 like illness and serologically confirmed SARS-CoV-2 infection.
Detailed description
Endpoints:Safety Endpoints- Occurrence of unsolicited systemic AEs reported in the 30 minutes after each injection.
Occurrence of solicited injection site reactions and systemicreactions occurring up to 7 days post-dose.
Occurrence of unsolicited non-serious AEs reported up to 28 dayspost-dose. Occurrence of SAEs and AESIs up to 6 months throughout the study. Immunogenicity Endpoints:GMT of neutralizing antibody will be measured with the neutralization assayon D01,D29.
Binding antibody titers to full length SARS-CoV-2 Spike (S) protein will be measured for each study intervention group with the ELISA method
- Antibody titer on D01, D08, D15, D29, D91, D181
- Fold-rise in antibody titer at D08, D15, D29, D91 and D181 post vaccination relative to D01
- 4-fold-rise in antibody titer at D08, D15, D29, D91, and D181 relative to D01 Neutralizing antibody titers will be measured with the neutralization assay
- Antibody titer on D08, D15, D29, D91 and D181
- Fold-rise (fold rise in serum neutralization titer post vaccination relative to D01) at D08, D15, D29, D91 and D181
- 4-fold rise in serum neutralization titer [post/pre] relative to D01 at D08, D15, D29, D91 and D181
- Occurrence of neutralizing antibody seroconversion, defined as baseline values below LLOQ at baseline with detectable neutralization titer above assay lower limit of quantification at D08, D15, D29, D91 and D181INF-γ, IL-4 and IL-2 will be measured in whole blood and/or cryopreserved PBMC following stimulation with pools of S
- ExploratoryCell-mediated immunity To describe the cellular immune response profile at D01, D08, D15 and D29, in a subset of 30 participants for each study group antigen peptides.
Virologically-confirmed COVID 19 like illness as defined by specified clinical symptoms and signs and confirmed by a positive result for SARS-CoV-2 nucleic acid viral detection assay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a randomized observer-blinded parallel controlled trial：Experimental group（mRNA vaccine） and positive control group（inactive vaccine）
| Arm | Type | Receives |
|---|---|---|
| SW-BIC-213 | Experimental | Biological: SW-BIC-213Intervention Name :COVID-19 mRNA vaccine Type :Investigational Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.5ml; Dosage Level(s) :0.25ml; Route of Administration: injection Intramuscular |
| SARS-Cov-2 Vaccina(Vero Cell ) Inactivated | Active comparator | Biological: SARS-Cov-2 Vaccina(Vero Cell ) InactivatedIntervention Name: COVID-19 Inactivated Vaccine Type : Control Vaccine Dose :Inactive Unit Dose Strength(s) : 0.5ml; Route of Administration Intramuscular : injection Intramuscular |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is willing and able to give written informed consent for participation in the study.
- Male or Female, aged 18 years or above and in good health as determined by study clinician.
- Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunization continuously until 3 months after boost immunization.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Subjects had completed the 2-dose series vaccination of COVID-19 inactivated vaccine at least .
Key exclusion criteria (14 listed)
- Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
- Self-reported history of SARS and MERS infection;
- Receipt of live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination;
- Receipt of any SARS-COV-2 vaccine after last dose of primary vaccination
- Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination.
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 |
|---|---|---|
| SW-BIC-213The patient will take a single 25 μg dose mRNA vaccine SW-BIC-213. | Biological | SW-BIC-213 |
| SARS-Cov-2 Vaccina(Vero Cell ) InactivatedThe patient will take a third dose of COVID-19 Inactivated vaccine. | Biological | SARS-Cov-2 Vaccina(Vero Cell ) Inactivated |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 6 months post-dose
To describe the safety profile of all participants in each group up to 6 months post-dose.
Immunogenicity of 28 days post dose
Time frame: 28 days post dose
To demonstrate the superiority of neutralizing antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine 28 days post dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 38169790Fang Y, Li JX, Duangdany D, Li Y, Guo XL, Phamisith C, Yu B, Shen MY, Luo B, Wang YZ, Liu SJ, Zhao FF, Xu CC, Qiu XH, Yan R, Gui YZ, Pei RJ, Wang J, Shen H, Guan WX, Li HW, Mayxay M. Safety, immunogenicity, and efficacy of a modified COVID-19 mRNA vaccine, SW-BIC-213, in healthy people aged 18 years and above: a phase 3 double-blinded, randomized, parallel controlled clinical trial in Lao PDR (Laos). EClinicalMedicine. 2023 Dec 13;67:102372. doi: 10.1016/j.eclinm.2023.102372. eCollection 2024 Jan.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayfong Mayxay, doctor principal investigator
National Ethics Committee for Health Research(NECHR)
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 SW-BIC-213 and SARS-Cov-2 Vaccina(Vero Cell ) Inactivated in people with Immunogenicity and Efficacy, run by Stemirna Therapeutics at 1 site in Laos.
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 6 inclusion and 14 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 12 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 Laos. 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 yang li, doctor (+856 02095779465, yang.li@stemirna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 6 months post-dose). 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?
On the ClinicalTrials.gov record for NCT05580159, which also lists 1 linked publication.
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 12 Apr 2023.