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COVID-19Phase 1NCT05394012

A Phase 1a 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..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase Ⅰa, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013. The study vaccine is administered IM at upper arm deltoid as a two-dose primary series on day 0, 28. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy 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
Dec 2022to Jun 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 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy participants 18-59 years, and both males and females should be included;
  • Participants who agree to participate in this clinical trial voluntarily and sign the informed consent form, capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
  • 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 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.).
  • Body mass index within range of 18~30 kg/m2

Who cannot join

  • Abnormal results of laboratory screening tests (exceeding the upper or lower limit of the normal reference range by a factor of 1.2) which was clinically significant judged by clinicians at screening;
  • Abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or pulse <50 beats/min or >100 beats/min under conscious state, or axillary temperature ≥ 37.3°C at screening;
  • Known allergy, or history of anaphylaxis, or other serious adverse reactions to study vaccine or its excipients;
  • History of human coronavirus infection/diseases, such as 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 either SARS-CoV-2 nucleic acid or antibody tests (IgG and IgM) at screening;
  • Administration of antipyretics or painkillers within 24 hours prior to vaccination;
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  • Receipt of any COVID-19 vaccine, live attenuated vaccine within 28 days prior to vaccination, subunit and inactivated vaccine within 14 days prior to vaccination;
  • Blood donation or blood loss (≥450 mL), or receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned blood donation or blood products use during the study period.
  • Participants with the following disease:
  • Any acute diseases or acute attacks of chronic diseases within 7 days prior to vaccination；
  • 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 musculoskeletal 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 need 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 procedure;
  • History of a major surgery, per the investigator's judgment, within 12 weeks before enrolment, 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;
  • Having participated or being participating in COVID-19 clinical trials, and those being participating or planning to participate in other clinical trials during the study period;
  • Receipt of any investigational or unlicensed products (drug, vaccine, biological product or device) other than the investigational vaccine within 3 months prior to signing the informed consent form, or plan to use them during the study;
  • 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 elicited response.

Trial locations and contacts

No sites are listed yet.

Shuyuan Yang contact

(+86)18687832269

ynwsysy@walvax.com

About this study

Official title: Randomized, Blinded, Positive Control Phase 1a Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine (RQ3013) in Healthy Adults Aged 18-59 Years

This is a phase Ⅰa, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013. The study vaccine is administered IM at upper arm deltoid as a two-dose primary series on day 0, 28.

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

    Two doses of 30 μg/0.15 mL at an interval of 28 days, or two doses of 60 μg/0.3 mL at an interval of 28 days

  • ComirnatyBiological

    Two doses of 30 μg/0.3 mL at an interval of 28 days

Study groups in NCT05394012
Study groupRoleWhat they receive
RQ3013ExperimentalNot described
Receives: Biological: RQ3013
ComirnatyActive comparatorNot described
Receives: Biological: Comirnaty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immediate adverse events (AEs) within 30 minutes after each vaccination, solicited local and systemic AEs for within 14 days and unsolicited AEs within 28 days following each vaccination

    Measured: within 14 days and 28 days following each vaccination

Secondary outcomes (8)

  1. Serious adverse events (SAEs) and adverse event of special interest (AESI) from first vaccination to 12 months after full immunization

    Measured: from first vaccination to 12 months after full immunization

  2. Changes of laboratory safety measures at day 4 following each vaccination in comparison to pre-vaccination levels

    Measured: day 4 following each vaccination in comparison to pre-vaccination levels

  3. Live virus GMT, GMFR and seroconversion rates against Beta and Omicron in serum at pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

    Measured: pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

  4. Pseudovirus GMT, GMFR and seroconversion rates against SARS-CoV-2 Beta and Omicron strain in serum at pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

    Measured: pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

  5. GMT, GMFR and seroconversion rates of S-Protein Specific IgGs at pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

    Measured: pre dose 1, 28 days post dose 1 (pre-dose 2), 14, 28 days post dose 2

  6. Live virus GMT, GMFR and seroconversion rates against Beta and Omicron in serum at month 3, 6, 12 months post dose 2

    Live virus GMT, GMFR and seroconversion rates against Beta and Omicron in serum at month 3, 6, 12 months post dose 2

    Measured: 3, 6, 12 months post dose 2

  7. Pseudovirus GMT, GMFR and seroconversion rates against SARS-CoV-2 Beta and Omicron strain at month 3, 6, 12 months post dose 2

    Measured: 3, 6, 12 months post dose 2

  8. GMT, GMFR and seroconversion rates of S-Protein Specific IgGs at month 3, 6, 12 months post dose 2

    Measured: 3, 6, 12 months post dose 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study startDec 2022 (estimated)
  3. Primary completionFeb 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05394012
Sponsor's protocol ID
RQ3013-004
Status last verified
Nov 2022
First submitted
25 May 2022
Last updated
18 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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 24 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 18 Nov 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 adverse events (AEs) within 30 minutes after each vaccination, solicited local and systemic AEs for within 14 days and unsolicited AEs within 28 days following each vaccination (time frame: within 14 days and 28 days following each vaccination). 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 NCT05394012.

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 18 Nov 2022.

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