ImmunogenicityPhase 3NCT05686161
mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs
A Phase 3 study testing SW-BIC-213;SARS-Cov-2., Sinopharm (BIBP);SARS-Cov-2. and Pfizer(BNT162b2);SARS-Cov-2. in people with Immunogenicity and Safety, run by Stemirna Therapeutics at 1 site in Laos.
Trial summary
Primary#Objectives #Immunogenicity:To demonstrate the non-inferiority of binding antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with mRNA COVID-19 vaccine(Pfizer) 14 days post dose. Secondary#Immunogenicity: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunogenicity, Safety, Efficacy
- What is being tested?
- SW-BIC-213;SARS-Cov-2., Sinopharm (BIBP);SARS-Cov-2. and Pfizer(BNT162b2);SARS-Cov-2.
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteLaos
- Study dates
- 19 Oct 2022to 27 Jun 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 3months 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(Sinopharm) 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
Show all 16Show fewer
- Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination
- 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
- Other reasons investigators did not consider it appropriate to refer to clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-blind, Parallel Controlled Trial to Evaluate the Immunogenicity ,Safety,Efficacy of A Heterologous Booster Dose With SW-BIC-213, in Previously Vaccinated Subjects Against COVID-19 With Two Inactivated COVID-19 Vaccine Doses Compared to a Booster Dose With Pfizer of Sinopharmin Adults
Primary#Objectives #Immunogenicity:To demonstrate the non-inferiority of binding antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with mRNA COVID-19 vaccine(Pfizer) 14 days post dose.
Secondary#Immunogenicity:
Read more
- To describe binding antibody profile at D01, D29 and D181 of each study group.
- To describe the neutralizing antibody profile at D15, D29 and D181 of each study intervention group.
Secondary#Safety:
To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with two Sinopharm doses.
Exploratory#Cell-mediated immunity:
To describe the cellular immune response profile at D01, D08, D15, in a subset of 30 participants for each study group.
Exploratory#Efficacy:
To describe theoccurrence ofvirologically-confirmedCOVID-19 like illness and serologicallyconfirmed SARS-CoV-2 infection.
Read the detailed description
Endpoint:
Immunogenicity Endpoints:
GMT of Anti-Spike IgG antibody titers will be measured with the ELISA assay on D01, D15.
Immunogenicity Endpoints:
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, D29, D181.
- Fold-rise in antibody titer at D15, D29 and D181 relative to D01Neutralizing antibody titers will be measured with the neutralization assay.
- Antibody titer on D15, D29 and D181.
- Fold rise in serum neutralization titer [post/pre] relative to D01 at D15, D29 and D181.
Safety Endpoints:
- Occurrence of local and systemic AEs reported within 7 days after study vaccination (per group);
- Occurrence of unsolicited AEs reported within 28 days after study vaccination (per group);
- Occurrence of SAEs and AESIs within 28 days after study vaccination (per group).
Exploratory#Cell-mediated immunity Endpoints:
INF-γ will be measured in whole blood and/or cryopreserved PBMC following stimulation with pools of S-antigen peptides.
Exploratory#Efficacy Endpoints Occurrence of confirmed symptomatic cases during the study period
- Conditions
- Immunogenicity, Safety, Efficacy
- Being tested
- SW-BIC-213;SARS-Cov-2., Sinopharm (BIBP);SARS-Cov-2., Pfizer(BNT162b2);SARS-Cov-2.
- 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-213;SARS-Cov-2.Biological
The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows:
Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life.
Sinopharm (BIBP);SARS-Cov-2.Biological
The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows:
Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life.
Pfizer(BNT162b2);SARS-Cov-2.Biological
The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows:
Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life.
| Study group | Role | What they receive |
|---|---|---|
| A single 25 μg dose mRNA vaccine 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. |
| A third dose of COVID-19 Inactivated vaccine | Active comparator | Intervention Name: COVID-19 Inactivated Vaccine Type : Control Vaccine Dose :Inactive Unit Dose Strength(s) : 0.5ml; Route of Administration: injection Intramuscular Receives: Biological: Sinopharm (BIBP);SARS-Cov-2. |
| A single 30μg dose mRNA vaccine Pfizer(BNT162b2) | Active comparator | Type :mRNA COVID -19 vaccine - Pfizer(BNT162b2) Dose :Formulation mRNA Unit Dose Strength(s) :30ug; Dosage Level(s) :0.3ml; Route of Administration: injection Intramuscular Receives: Biological: Pfizer(BNT162b2);SARS-Cov-2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
GMT of Anti-Spike IgG antibody titers will be measured with the ELISA assay on day1 , day 15
Measured: day1, day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start19 Oct 2022
- Primary completion7 Dec 2022
- Study completion27 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (actual)
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
- NCT05686161
- Sponsor's protocol ID
- SWC310-1
- Status last verified
- Oct 2022
- First submitted
- 20 Dec 2022
- Last updated
- 17 Jan 2023
- 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Parallel Controlled Trial to Evaluate the Immunogenicity ,Safety,Efficacy of A Heterologous Booster Dose With SW-BIC-213, in Previously Vaccinated Subjects Against COVID-19 With Two Inactivated COVID-19 Vaccine Doses Compared to a Booster Dose With Pfizer of Sinopharmin Adults
- ClinicalTrials.gov ID
- NCT05686161
- Acronym / sponsor ID
- SWC310-1
- Conditions
- Immunogenicity, Safety, Efficacy
- Keywords
- new generation mRNA vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Stemirna TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 27 Jun 2023 (estimated)
- First posted
- 17 Jan 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.
Primary#Objectives #Immunogenicity:To demonstrate the non-inferiority of binding antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with mRNA COVID-19 vaccine(Pfizer) 14 days post dose.
Secondary#Immunogenicity:
- To describe binding antibody profile at D01, D29 and D181 of each study group.
- To describe the neutralizing antibody profile at D15, D29 and D181 of each study intervention group.
Secondary#Safety:
To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with two Sinopharm doses.
Exploratory#Cell-mediated immunity:
To describe the cellular immune response profile at D01, D08, D15, in a subset of 30 participants for each study group.
Exploratory#Efficacy:
To describe theoccurrence ofvirologically-confirmedCOVID-19 like illness and serologicallyconfirmed SARS-CoV-2 infection.
Detailed description
Endpoint:
Immunogenicity Endpoints:
GMT of Anti-Spike IgG antibody titers will be measured with the ELISA assay on D01, D15.
Immunogenicity Endpoints:
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, D29, D181.
- Fold-rise in antibody titer at D15, D29 and D181 relative to D01Neutralizing antibody titers will be measured with the neutralization assay.
- Antibody titer on D15, D29 and D181.
- Fold rise in serum neutralization titer [post/pre] relative to D01 at D15, D29 and D181.
Safety Endpoints:
- Occurrence of local and systemic AEs reported within 7 days after study vaccination (per group);
- Occurrence of unsolicited AEs reported within 28 days after study vaccination (per group);
- Occurrence of SAEs and AESIs within 28 days after study vaccination (per group).
Exploratory#Cell-mediated immunity Endpoints:
INF-γ will be measured in whole blood and/or cryopreserved PBMC following stimulation with pools of S-antigen peptides.
Exploratory#Efficacy Endpoints Occurrence of confirmed symptomatic cases during the study period
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- a randomized observer-blinded parallel controlled trial#Experimental group#mRNA vaccine# and positive control group#inactive vaccine#
| Arm | Type | Receives |
|---|---|---|
| A single 25 μg dose mRNA vaccine SW-BIC-213 | Experimental | Biological: SW-BIC-213;SARS-Cov-2.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 |
| A third dose of COVID-19 Inactivated vaccine | Active comparator | Biological: Sinopharm (BIBP);SARS-Cov-2.Intervention Name: COVID-19 Inactivated Vaccine Type : Control Vaccine Dose :Inactive Unit Dose Strength(s) : 0.5ml; Route of Administration: injection Intramuscular |
| A single 30μg dose mRNA vaccine Pfizer(BNT162b2) | Active comparator | Biological: Pfizer(BNT162b2);SARS-Cov-2.Type :mRNA COVID -19 vaccine - Pfizer(BNT162b2) Dose :Formulation mRNA Unit Dose Strength(s) :30ug; Dosage Level(s) :0.3ml; Route of Administration: injection Intramuscular |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 3months 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(Sinopharm) at least 24 weeks with the completed the 2-dose Series as the primary vaccination according to the product label.
Key exclusion criteria (16 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
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-213;SARS-Cov-2.The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life. | Biological | A single 25 μg dose mRNA vaccine SW-BIC-213 |
| Sinopharm (BIBP);SARS-Cov-2.The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life. | Biological | A third dose of COVID-19 Inactivated vaccine |
| Pfizer(BNT162b2);SARS-Cov-2.The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life. | Biological | A single 30μg dose mRNA vaccine Pfizer(BNT162b2) |
Primary outcome
Immunogenicity
Time frame: day1, day15
GMT of Anti-Spike IgG antibody titers will be measured with the ELISA assay on day1 , day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- 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;SARS-Cov-2., Sinopharm (BIBP);SARS-Cov-2. and Pfizer(BNT162b2);SARS-Cov-2. in people with Immunogenicity and Safety, 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 5 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 17 Jan 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?
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?
Immunogenicity (time frame: day1, day15). 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 17 Jan 2023.