COVID-19 PandemicPhase 1/2NCT05144139
A Phase I/II Clinical Trial in Healthy People Aged 18 Years and Above
A Phase 1/2 study testing COVID-19 mRNA vaccine in people with COVID-19 Pandemic, run by Stemirna Therapeutics at 1 site in Laos.
Trial summary
This clinical trial is a phase I/II clinical trial to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18 years and above. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- COVID-19 mRNA vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteLaos
- Study dates
- 3 Dec 2021to 11 Nov 2022
- Phase
- Phase 1/2
- 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
- People aged 18-60 years (both inclusive) for phase 1 and aged ≥18 years for phase 2；
- Medical history and physical examination indicating as a healthy person;
- The female participant or the spouse (or partner) of the male participant in child-birthing age agrees to use effective contraceptive measure throughout the whole course of this clinical trial.
- Those who are participating in this clinical trial voluntarily, have signed the informed consent form, and been able to understand and comply with the requirements of the clinical trial protocol.
Who cannot join
- Confirmed cases or history of SARS-CoV-2 infection;
- Has a history of SARS and MERS virus infection;
- Has fever (axillary temperature ≥37.3℃), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, and dyspnea within 14 days before vaccination;
- Positive urine pregnancy test；
- Axillary temperature ≥37.3℃ at the day vaccinated;
- History of severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurosis, edema, etc.) or allergies to known components of COVID-19 mRNA vaccine;
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- History or family history of convulsions, epilepsy, encephalopathy, or mental illness;
- Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Known suffering from diseases including: acute respiratory disease (such as flu-like illness, acute cough, sore throat), severe cardiovascular disease, kidney disease, uncontrolled hypertension (systolic blood pressure >150 mmHg, diastolic blood pressure >90 mmHg), diabetes complications, malignant tumor, all sorts of acute illness or chronic diseases acute phase;
- Diagnosis with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune disease;
- Abnormal coagulation function (such as lack of coagulation factor, coagulation disorders);
- Receiving anti-tuberculosis treatment;
- Long-term receipt (continuous≥7 days) of glucocorticoid (reverence value for dose: amount to≥20 mg/d prednisone equivalent), except inhaled, topical, nasal, aural and ophthalmic corticosteroids, within 6 months before screening; Receipt of immunotherapy or immunosuppressant within 3 months (continuous oral or infusion for more than 14 days);
- Receipt of live attenuated vaccine within 28 days prior to vaccination and other vaccines within 14 days prior to vaccination;
- Receipt of blood products within 3 months prior to vaccination
- Receipt of other study drugs within 6 months prior to vaccination;
- Receipt of any SARS-COV-2 vaccine;
- Other situations judged by the investigators that are not suitable for participating in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Clinical Trial to Evaluate the Safety, Immunogenicity and Immune Persistence of COVID-19 mRNA Vaccine in Healthy People Aged 18 Years and Above.
This clinical trial is a phase I/II clinical trial to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18 years and above.
Read the detailed description
This is the clinical trial including an open-label, single-arm Phase I study and a subsequent randomized, blind, placebo-parallel controlled Phase II study to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18-60 years and ≥18 years respectively, whose locations or circumstances put them at appreciable risk of acquiring COVID-19 and/or SARS-CoV-2 infection.
- Conditions
- COVID-19 Pandemic
- Being tested
- COVID-19 mRNA 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.
COVID-19 mRNA vaccineBiological
Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval
| Study group | Role | What they receive |
|---|---|---|
| Low dose group with mRNA vaccine | Experimental | 25μg with COVID-19 mRNA vaccine Receives: Biological: COVID-19 mRNA vaccine |
| Low dose group with placebo | Placebo comparator | Low dose group with placebo Receives: Biological: COVID-19 mRNA vaccine |
| High dose group with mRNA vaccine | Experimental | 45μg with COVID-19 mRNA vaccine Receives: Biological: COVID-19 mRNA vaccine |
| High dose group with placebo | Placebo comparator | High dose group with placebo Receives: Biological: COVID-19 mRNA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
local/systemic solicited adverse reaction/events
The incidence of local/systemic solicited adverse reaction/events
Measured: up to 6 days after each dose
unsolicited adverse events
The incidence of unsolicited adverse events
Measured: up to 21 days and up to 28 days after the first and second dose of immunization, respectively
The incidence of SAE
The incidence of SAE from the first dose of vaccination to 28 days after the full course of immunization
Measured: up to 28 days after the full course of immunization
Secondary outcomes (3)
The seroconversion rate, 2-fold or 4-fold rise and GMT/GMI of the SARS-COV-2 S-protein specific antibody (specific total antibody/IgG antibody) and neutralizing antibody
The seroconversion rate, 2-fold or 4-fold rise and GMT/GMI of the SARS-COV-2 S-protein specific antibody (specific total antibody/IgG antibody) and neutralizing antibody 14 days after the full immunization in the subjects who take two doses as protocol specified
Measured: 14 days after the full immunization
The incidence of SAE
The incidence of SAE within the 29th ~365th day after the full course of immunization
Measured: the 29th ~365th day after the full course of immunization
Changes in laboratory abnormal parameters
Changes in laboratory abnormal parameters in the participants who take at least of one dose
Measured: after at least of one dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start3 Dec 2021
- Primary completion28 Aug 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemirna Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayfong Mayxay, professor, Principal investigator, Mahosot Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144139
- Sponsor's protocol ID
- SWC002
- Status last verified
- Oct 2022
- First submitted
- 11 Nov 2021
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial to Evaluate the Safety, Immunogenicity and Immune Persistence of COVID-19 mRNA Vaccine in Healthy People Aged 18 Years and Above.
- ClinicalTrials.gov ID
- NCT05144139
- Acronym / sponsor ID
- SWC002
- Conditions
- COVID-19 Pandemic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Stemirna TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 28 Aug 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 3 Dec 2021 (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 clinical trial is a phase I/II clinical trial to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18 years and above.
Detailed description
This is the clinical trial including an open-label, single-arm Phase I study and a subsequent randomized, blind, placebo-parallel controlled Phase II study to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18-60 years and ≥18 years respectively, whose locations or circumstances put them at appreciable risk of acquiring COVID-19 and/or SARS-CoV-2 infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose group with mRNA vaccine | Experimental | Biological: COVID-19 mRNA vaccine25μg with COVID-19 mRNA vaccine |
| Low dose group with placebo | Placebo comparator | Biological: COVID-19 mRNA vaccineLow dose group with placebo |
| High dose group with mRNA vaccine | Experimental | Biological: COVID-19 mRNA vaccine45μg with COVID-19 mRNA vaccine |
| High dose group with placebo | Placebo comparator | Biological: COVID-19 mRNA vaccineHigh dose group with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People aged 18-60 years (both inclusive) for phase 1 and aged ≥18 years for phase 2；
- Medical history and physical examination indicating as a healthy person;
- The female participant or the spouse (or partner) of the male participant in child-birthing age agrees to use effective contraceptive measure throughout the whole course of this clinical trial.
- Those who are participating in this clinical trial voluntarily, have signed the informed consent form, and been able to understand and comply with the requirements of the clinical trial protocol.
Key exclusion criteria (18 listed)
- Confirmed cases or history of SARS-CoV-2 infection;
- Has a history of SARS and MERS virus infection;
- Has fever (axillary temperature ≥37.3℃), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, and dyspnea within 14 days before vaccination;
- Positive urine pregnancy test；
- Axillary temperature ≥37.3℃ at the day vaccinated;
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 |
|---|---|---|
| COVID-19 mRNA vaccineIntramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval | Biological | High dose group with mRNA vaccine, High dose group with placebo, Low dose group with mRNA vaccine, Low dose group with placebo |
Primary outcome
local/systemic solicited adverse reaction/events
Time frame: up to 6 days after each dose
The incidence of local/systemic solicited adverse reaction/events
unsolicited adverse events
Time frame: up to 21 days and up to 28 days after the first and second dose of immunization, respectively
The incidence of unsolicited adverse events
The incidence of SAE
Time frame: up to 28 days after the full course of immunization
The incidence of SAE from the first dose of vaccination to 28 days after the full course of immunization
3 secondary outcomes
The seroconversion rate, 2-fold or 4-fold rise and GMT/GMI of the SARS-COV-2 S-protein specific antibody (specific total antibody/IgG antibody) and neutralizing antibody
Time frame: 14 days after the full immunization
The incidence of SAE
Time frame: the 29th ~365th day after the full course of immunization
Changes in laboratory abnormal parameters
Time frame: after at least of one dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- 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, professor principal investigator
Mahosot Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing COVID-19 mRNA vaccine in people with COVID-19 Pandemic, 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 4 inclusion and 18 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: finished, as of the sponsor's last update on 28 Dec 2022. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
local/systemic solicited adverse reaction/events (time frame: up to 6 days after each dose). The study lists 3 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 28 Dec 2022.