COVID-19Phase 1NCT05396573
A Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine Against COVID-19
A Phase 1 study testing RQ3013 and Comirnaty in people with COVID-19, run by Walvax Biotechnology Co., Ltd..
Trial summary
This is a phase 1b, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013 in healthy adults primed with a two-dose inactivated vaccine 6-9 months earlier. 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
- What is being tested?
- RQ3013 and Comirnaty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jul 2023
- Phase
- Phase 1
- 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
- Healthy participants 18-59 years and 60 years and older, and both males and females should be included;
- Participants who agree to participate in this clinical trial voluntarily and sign the informed consent form, are capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
- Participants who have been primed with a two-dose inactivated vaccine 6-9 months earlier, and the intervals between the two inactivated vaccines was between 21 and 42 days.
- For female participants of childbearing potential, effective contraception measures should be used within 2 weeks prior to participation in this study and the results of the pregnancy test must be negative. Participants must voluntarily agree to use effective contraceptive measures from the time of signing the informed consent form to the end of the study (effective contraceptive measures including oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).
Who cannot join
- Receipt of any COVID-19 prophylactic medication other than a primary series of inactivated vaccine (e.g., receipt history of any approved or under developing COVID-19 vaccines, or other COVID-19 prophylactic medication, etc.), or non-standard primary series of inactivated vaccine;
- Abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmHg (≥150 mmHg for participants aged ≥ 60 years) and/or diastolic blood pressure ≥90 mmHg, or axillary body temperature ≥ 37.3°C, or abnormal results of laboratory screening tests which was clinically significant at screening;
- Known allergy, or history of anaphylaxis or other serious adverse reactions to the study vaccine or its excipients;
- History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
- History of COVID-19, or history of close contact with confirmed/suspected COVID-19 patients, or positive results for SARS-CoV-2 nucleic acid tests at screening;
- Administration of antipyretics or painkillers within 24 hours prior to vaccination;
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- Receipt of any live attenuated vaccine within 28 days prior to vaccination, or subunit and inactivated vaccine within 14 days prior to vaccination;
- Receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned use during the study period.
- Participants with the following diseases:
- Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment；
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.；
- Congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids；
- Currently suffering from or previously diagnosed with infectious diseases, positive screening results for hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, human immunodeficiency virus antibody；
- History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders；
- Asplenia, or functional asplenia；
- Presence of severe, uncontrollable or hospitalization indicated cardiovascular diseases, diabetes, blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors, except for history of well-controlled chronic diseases, such as diabetes, hypertension, etc.;
- Participants who cannot tolerate venepuncture, or have a history of needle or blood phobia;
- Contraindications to IM injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage.
- Drug or alcohol abuse (alcohol intake ≥ 14 units per week) which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures;
- History of a major surgery, per the investigator's judgment, within 12 weeks before vaccination, or not achieving full recovery after surgery, or any planned major surgery during the study;
- Pregnant or lactating females; males whose partner plans to conceive; males or females who plan to donate sperm or eggs;
- Participating or planning to participate in other clinical trials during the study period;
- Presence of any underlying disease or condition which, in the opinion of the investigator, may place the participant at unacceptable risk, make the participant unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Blinded, Positive Control Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine (RQ3013) in Healthy Adults Completed a Two-dose Primary Series of Inactivated Vaccine
This is a phase 1b, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013 in healthy adults primed with a two-dose inactivated vaccine 6-9 months earlier. The study vaccine is administered IM in the upper arm deltoid as single booster shot on day 0.
- Conditions
- COVID-19
- Being tested
- RQ3013, Comirnaty
- 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
A single dose of 30 μg/0.15 mL, a single dose of 60 μg/0.3 mL
ComirnatyBiological
A single dose of 30 μg/0.3 mL
| Study group | Role | What they receive |
|---|---|---|
| RQ3013 | Experimental | Not described Receives: Biological: RQ3013 |
| Comirnaty | Active comparator | Not described Receives: Biological: Comirnaty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate AEs within 30 minutes after booster vaccination, solicited local and systemic AEs for within 7 days and unsolicited AEs within 28 days following booster vaccination
Measured: within 28 days following booster vaccination
Secondary outcomes (8)
Live virus GMT, GMFR and seroconversion rate against Beta and Omicron strain in serum measured at pre booster dose and day 7, 14, 28 after booster dose
Measured: pre booster dose and day 7, 14, 28 after booster dose
Pseudovirus GMT, GMFR and seroconversion rate against SARS-CoV-2 Beta and Omicron strain in serum measured at pre booster dose and day 7, 14, 28 after booster dose
Measured: pre booster dose and day 7, 14, 28 after booster dose
GMT, GMFR and seroconversion rate of S-Protein Specific IgGs in serum measured at pre booster dose and day 7, 14, 28 after booster dose
Measured: pre booster dose and day 7, 14, 28 after booster dose
Live virus GMT, GMFR and seroconversion rate against Beta and Omicron strain in serum measured at 3, 6, 12 months after booster dose
Measured: 3, 6, 12 months after booster dose
Pseudovirus GMT, GMFR and seroconversion rate against SARS-CoV-2 Beta and Omicron strain in serum measured at 3, 6, 12 months after booster dose
Measured: 3, 6, 12 months after booster dose
GMT, GMFR and seroconversion rate of S-Protein Specific IgGs in serum measured at 3, 6, 12 months after booster dose
Measured: 3, 6, 12 months after booster dose
Changes of safety laboratory measures at day 4 following booster vaccination in comparison to pre-boosting levels
Measured: day 4 following booster vaccination
SAEs and AESIs throughout the study
Measured: 12 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study startJul 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionJul 2023 (estimated)
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walvax Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai RNACure Biopharma Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lin Yuan, Study director, Walvax Biotechnology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396573
- Sponsor's protocol ID
- RQ3013-005
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Positive Control Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine (RQ3013) in Healthy Adults Completed a Two-dose Primary Series of Inactivated Vaccine
- ClinicalTrials.gov ID
- NCT05396573
- Acronym / sponsor ID
- RQ3013-005
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Walvax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai RNACure Biopharma Co., Ltd.
- Study start
- Jul 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 31 May 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 is a phase 1b, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013 in healthy adults primed with a two-dose inactivated vaccine 6-9 months earlier. The study vaccine is administered IM in the upper arm deltoid as single booster shot on day 0.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RQ3013 | Experimental | Biological: RQ3013 |
| Comirnaty | Active comparator | Biological: Comirnaty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy participants 18-59 years and 60 years and older, and both males and females should be included;
- Participants who agree to participate in this clinical trial voluntarily and sign the informed consent form, are capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
- Participants who have been primed with a two-dose inactivated vaccine 6-9 months earlier, and the intervals between the two inactivated vaccines was between 21 and 42 days.
- For female participants of childbearing potential, effective contraception measures should be used within 2 weeks prior to participation in this study and the results of the pregnancy test must be negative. Participants must voluntarily agree to use effective contraceptive measures from the time of signing the informed consent form to the end of the study (effective contraceptive measures including oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).
Key exclusion criteria (23 listed)
- Receipt of any COVID-19 prophylactic medication other than a primary series of inactivated vaccine (e.g., receipt history of any approved or under developing COVID-19 vaccines, or other COVID-19 prophylactic medication, etc.), or non-standard primary series of inactivated vaccine;
- Abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmHg (≥150 mmHg for participants aged ≥ 60 years) and/or diastolic blood pressure ≥90 mmHg, or axillary body temperature ≥ 37.3°C, or abnormal results of laboratory screening tests which was clinically significant at screening;
- Known allergy, or history of anaphylaxis or other serious adverse reactions to the study vaccine or its excipients;
- History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
- History of COVID-19, or history of close contact with confirmed/suspected COVID-19 patients, or positive results for SARS-CoV-2 nucleic acid tests at screening;
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 |
|---|---|---|
| RQ3013A single dose of 30 μg/0.15 mL, a single dose of 60 μg/0.3 mL | Biological | RQ3013 |
| ComirnatyA single dose of 30 μg/0.3 mL | Biological | Comirnaty |
Primary outcome
Immediate AEs within 30 minutes after booster vaccination, solicited local and systemic AEs for within 7 days and unsolicited AEs within 28 days following booster vaccination
Time frame: within 28 days following booster vaccination
8 secondary outcomes
Live virus GMT, GMFR and seroconversion rate against Beta and Omicron strain in serum measured at pre booster dose and day 7, 14, 28 after booster dose
Time frame: pre booster dose and day 7, 14, 28 after booster dose
Pseudovirus GMT, GMFR and seroconversion rate against SARS-CoV-2 Beta and Omicron strain in serum measured at pre booster dose and day 7, 14, 28 after booster dose
Time frame: pre booster dose and day 7, 14, 28 after booster dose
GMT, GMFR and seroconversion rate of S-Protein Specific IgGs in serum measured at pre booster dose and day 7, 14, 28 after booster dose
Time frame: pre booster dose and day 7, 14, 28 after booster dose
Live virus GMT, GMFR and seroconversion rate against Beta and Omicron strain in serum measured at 3, 6, 12 months after booster dose
Time frame: 3, 6, 12 months after booster dose
Pseudovirus GMT, GMFR and seroconversion rate against SARS-CoV-2 Beta and Omicron strain in serum measured at 3, 6, 12 months after booster dose
Time frame: 3, 6, 12 months after booster dose
GMT, GMFR and seroconversion rate of S-Protein Specific IgGs in serum measured at 3, 6, 12 months after booster dose
Time frame: 3, 6, 12 months after booster dose
Changes of safety laboratory measures at day 4 following booster vaccination in comparison to pre-boosting levels
Time frame: day 4 following booster vaccination
SAEs and AESIs throughout the study
Time frame: 12 months after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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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.
Lin Yuan study director
Walvax Biotechnology Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RQ3013 and Comirnaty in people with COVID-19, run by Walvax Biotechnology Co., Ltd..
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 23 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 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 Shuyuan Yang ((+86)18687832269, ynwsysy@walvax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate AEs within 30 minutes after booster vaccination, solicited local and systemic AEs for within 7 days and unsolicited AEs within 28 days following booster vaccination (time frame: within 28 days following booster vaccination). 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 31 May 2022.