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
Brief 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 adultsprimed with a two-dose inactivated vaccine 6-9 months earlier. The study vaccine isadministered IM in the upper arm deltoid as single booster shot on day 0.

Detailed Description

Not Provided

Unknown status
COVID-19

Biological: RQ3013

A single dose of 30 μg/0.15 mL, a single dose of 60 μg/0.3 mL

Biological: Comirnaty

A single dose of 30 μg/0.3 mL

Eligibility Criteria

Inclusion Criteria:

1. Healthy participants 18-59 years and 60 years and older, and both males and females
should be included;

2. 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.

3. 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.

4. 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.).

Exclusion Criteria:

1. 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;

2. 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;

3. Known allergy, or history of anaphylaxis or other serious adverse reactions to the
study vaccine or its excipients;

4. History of severe acute respiratory syndrome (SARS) or Middle East respiratory
syndrome (MERS);

5. 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;

6. Administration of antipyretics or painkillers within 24 hours prior to vaccination;

7. Receipt of any live attenuated vaccine within 28 days prior to vaccination, or
subunit and inactivated vaccine within 14 days prior to vaccination;

8. Receipt of blood or blood-related products, including immunoglobulins, within 3
months prior to vaccination; or any planned use during the study period.

9. Participants with the following diseases:

1. Any acute diseases or acute attacks of chronic diseases within 7 days prior to
enrolment;

2. Congenital malformations or developmental disorders, genetic defects, severe
malnutrition, etc.;

3. 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;

4. 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;

5. History or family history of neurological disorders (convulsions, epilepsy,
encephalopathy, etc.) or psychiatric disorders;

6. Asplenia, or functional asplenia;

7. 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.;

8. Participants who cannot tolerate venepuncture, or have a history of needle or
blood phobia;

9. Contraindications to IM injections and blood draws, such as coagulation
disorders, thrombotic or bleeding disorders, or conditions that needs
continuous anticoagulant usage.

10. 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;

11. 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;

12. Pregnant or lactating females; males whose partner plans to conceive; males or
females who plan to donate sperm or eggs;

13. Participating or planning to participate in other clinical trials during the study
period;

14. 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Locations

Not Provided

Contacts

Shuyuan Yang
(+86)18687832269
ynwsysy@walvax.com

Lin Yuan, Study Director
Walvax Biotechnology Co., Ltd.

Shanghai RNACure Biopharma Co., Ltd.
NCT Number
MeSH Terms
COVID-19