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| Name | Class |
|---|---|
| Shanghai RNACure Biopharma Co., Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RQ3013 | Experimental |
| |
| Comirnaty | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RQ3013 | Biological | A single dose of 30 μg/0.15 mL, a single dose of 60 μg/0.3 mL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 28 days following booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Spike protein specific CD4+, CD8+, CD4+IFN-γ+, CD4+IL-2+, CD4+TNFα+, CD4+IL-4+, CD4+IL-13+, CD8+IFN-γ+, CD8+IL-2+, CD8+TNFα+ cytokine profiling (flow cytometry) by flow cytometry at baseline and day 7, 14 after booster | baseline and day 7, 14 after booster | |
| Spike protein specific cytokine responses by enzyme-linked immunospot (ELISPOT) assay, IFN-γ, IL-2, IL-4 at baseline and day 7, 14 after booster |
Inclusion Criteria:
Exclusion Criteria:
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;
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuyuan Yang | Contact | (+86)18687832269 | ynwsysy@walvax.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Yuan | Walvax Biotechnology Co., Ltd. | Study Director |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722726 | RQ3013 COVID-19 vaccine |
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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| Comirnaty |
| Biological |
A single dose of 30 μg/0.3 mL |
|
| 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 | 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 | 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 | 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 | 3, 6, 12 months after booster dose |
| Changes of safety laboratory measures at day 4 following booster vaccination in comparison to pre-boosting levels | day 4 following booster vaccination |
| SAEs and AESIs throughout the study | 12 months after vaccination |
| baseline and day 7, 14 after booster |
| Spike protein specific T memory cell responses: CD4+ and CD8+ TCM(CCR7+CD45RA-), TEM(CCR7-CD45RA-) and TSCM(CCR7+CD45RA+CD95+) at baseline and 28 days, 3, 6 months after booster | baseline and 28 days, 3, 6 months after booster |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |