COVID-19NCT05907044
A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults
A study testing RQ3013, RQ3025 and RQ3027 in people with COVID-19, run by Affiliated Hospital of Yunnan University at 1 site in China.
Trial summary
This clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are: The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- RQ3013, RQ3025 and RQ3027
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2023to 23 Nov 2023
- Phase
- Interventional
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
- Participants 18 through 55 years of ages.
- Participants who have received at least 3 doses COVID-19 vaccine.
- Participants with the last prior dose being 90 or more days before Visit 1(Day 0) or recovered from COVID-19 at least 28 days.
- Participants able to comply with all scheduled visits, laboratory tests and investigator's instruction.
Who cannot join
- Women who are pregnant or breastfeeding.
- Enrolling in or planning to participate other interventional clinical study.
- Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
- History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
- Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
- Continued using anticoagulants such as coumarin and related anticoagulants (i.e., warfarin) or oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran, and edoxaban).
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- Having coronary heart disease, hypertension, diabetes, chronic respiratory diseases, tumors and poorly controlled.
- Immunocompromised or having immunosuppressive therapy.
- Suspected or confirmed alcohol/drug dependence.
- Investigator decide unsuitable factors for participating in clinical trials in the investigator's judgment
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Yunnan University
Kunming, Yunnan, 650091
About this study
Official title: An Interventional, Randomized, Parallel Controlled, Investigator Initiated Study to Investigate the Safety, Immunogenicity of Bivalent RQ3027 and RQ3025 mRNA Vaccine as a Booster Dose in 3 Doses COVID-19 Vaccine-Experienced Healthy Adults
This clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are:
- The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA vaccine RQ3013 against the current SARS-CoV-2 circulating variant.
- The safety profile of RQ3027 and RQ3025 given as a second booster dose to COVID-19 vaccine-experienced participants 18 through 55 years of age.
- Explore the protective efficacy by documenting confirmed COVID-19 cases after vaccination.
- Conditions
- COVID-19
- Being tested
- RQ3013, RQ3025, RQ3027
- Keywords
- mRNA vaccine, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RQ3013Biological
0.15mL/dose containing mRNA 30μg
RQ3025Biological
0.15mL/dose containing mRNA 30μg
RQ3027Biological
0.15mL/dose containing mRNA 30μg
| Study group | Role | What they receive |
|---|---|---|
| RQ3013 | Active comparator | C-3013B-202211005, Alpha/Beta, mRNA 30μg dose Receives: Biological: RQ3013 |
| RQ3025 | Experimental | INDA-3025TB-20221002, Alpha/Beta + Omicron BA.2/4/5, mRNA 30μg dose Receives: Biological: RQ3025 |
| RQ3027 | Experimental | IND-3027TB-202304001, Alpha/Beta + Omicron XBB.1.5, mRNA 30μg dose Receives: Biological: RQ3027 |
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 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
Measured: Day 14
Number of Participants with Solicited Local and Systemic Averse Events(AEs)
Measured: Up to Day 14( 7 days after vaccination)
Secondary outcomes (4)
Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
Measured: Day 0, Day 7, Day 28, Day 90, Day 180
Number of Participants with Unsolicited Local and Systemic Averse Events(AEs)
Measured: Up to Day 180( 28 days after vaccination)
Number of Participants with Serious AEs(SAEs)
Measured: Up to Day 180
The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-γ, IL-4)
Measured: Day 7, Day 28, Day 90, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start8 May 2023
- Primary completion10 Jun 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Yunnan University
- Sponsor type
- University, hospital or other
- Collaborators
- Yunnan University, Kunming Medical University
- Responsible party
- Principal investigator, Jia Wei, Affiliated Hospital of Yunnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907044
- Sponsor's protocol ID
- YNUVC-2022003
- Status last verified
- Jan 2024
- First submitted
- 8 Jun 2023
- Last updated
- 24 Jan 2024
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Randomized, Parallel Controlled, Investigator Initiated Study to Investigate the Safety, Immunogenicity of Bivalent RQ3027 and RQ3025 mRNA Vaccine as a Booster Dose in 3 Doses COVID-19 Vaccine-Experienced Healthy Adults
- ClinicalTrials.gov ID
- NCT05907044
- Acronym / sponsor ID
- YNUVC-2022003
- Conditions
- COVID-19
- Keywords
- mRNA vaccine, SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Affiliated Hospital of Yunnan UniversityUniversity, hospital or other
- Collaborators
- Yunnan University, Kunming Medical University
- Study start
- 8 May 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 18 Jun 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 clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are:
- The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA vaccine RQ3013 against the current SARS-CoV-2 circulating variant.
- The safety profile of RQ3027 and RQ3025 given as a second booster dose to COVID-19 vaccine-experienced participants 18 through 55 years of age.
- Explore the protective efficacy by documenting confirmed COVID-19 cases after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RQ3013 | Active comparator | Biological: RQ3013C-3013B-202211005, Alpha/Beta, mRNA 30μg dose |
| RQ3025 | Experimental | Biological: RQ3025INDA-3025TB-20221002, Alpha/Beta + Omicron BA.2/4/5, mRNA 30μg dose |
| RQ3027 | Experimental | Biological: RQ3027IND-3027TB-202304001, Alpha/Beta + Omicron XBB.1.5, mRNA 30μg dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
- Participants 18 through 55 years of ages.
- Participants who have received at least 3 doses COVID-19 vaccine.
- Participants with the last prior dose being 90 or more days before Visit 1(Day 0) or recovered from COVID-19 at least 28 days.
- Participants able to comply with all scheduled visits, laboratory tests and investigator's instruction.
Key exclusion criteria (10 listed)
- Women who are pregnant or breastfeeding.
- Enrolling in or planning to participate other interventional clinical study.
- Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
- History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
- Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
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 |
|---|---|---|
| RQ30130.15mL/dose containing mRNA 30μg | Biological | RQ3013 |
| RQ30250.15mL/dose containing mRNA 30μg | Biological | RQ3025 |
| RQ30270.15mL/dose containing mRNA 30μg | Biological | RQ3027 |
Primary outcome
Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
Time frame: Day 14
Number of Participants with Solicited Local and Systemic Averse Events(AEs)
Time frame: Up to Day 14( 7 days after vaccination)
4 secondary outcomes
Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
Time frame: Day 0, Day 7, Day 28, Day 90, Day 180
Number of Participants with Unsolicited Local and Systemic Averse Events(AEs)
Time frame: Up to Day 180( 28 days after vaccination)
Number of Participants with Serious AEs(SAEs)
Time frame: Up to Day 180
The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-γ, IL-4)
Time frame: Day 7, Day 28, Day 90, Day 180
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 24 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RQ3013, RQ3025 and RQ3027 in people with COVID-19, run by Affiliated Hospital of Yunnan University at 1 site in China.
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 10 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 24 Jan 2024. 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 China. 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.
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?
Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5 (time frame: Day 14). 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?
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 24 Jan 2024.