Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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;
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:
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.
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
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Central trial contact
Shuyuan Yang
Data sourced from clinicaltrials.gov
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