A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Enrollment
- 942
- Locations
- 1
- Primary Endpoint
- Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is a randomized, double-blinded, and placebo-controlled phase Ia/IIa clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged 18~59 Years.
Detailed Description
This phase Ia/IIa trial is designed to evaluate the safety and immunogenicity of different doses of the Inactivated SARS-CoV-2 Vaccine inoculated with different immunization schedules based upon the randomized, double-blind and placebo-controlled principle. A total of 942 subjects aged 18 to 59 years old will be enrolled in the study, of which 192 and 750 will be enrolled for phase Ia and phase Ⅱa,respectively.The enrolled subjects in phase Ia receive two doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 14 or 28 days, while the enrolled subjects in Phase Ⅱa receive two doses of medium, high-dose experimental vaccines or placebo at an interval of 14 or 28 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Phase Ia:
- •Healthy adults aged 18 to 59 years (including boundary values), both men and women.
- •Proven legal identity.
- •Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
- •Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
- •Axillary temperature ≤37.0 ℃.
- •Phase IIa:
- •Healthy adults aged 18 to 59 years (including boundary values), both men and women.
- •Proven legal identity.
- •Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
Exclusion Criteria
- •Phase Ia:
- •Contraindications for vaccination.
- •History of allergy to vaccines or drugs.
- •Immunization with any vaccine within 1 month.
- •History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
- •Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
- •Those who have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis or bleeding disorders.
- •Those who cannot tolerate venipuncture, or have a history of halo needles or halo blood.
- •Surgical removal of spleen or other important organs for any reason.
- •Those who have undergone surgery within 3 months before signing the informed consent, or those who plan to perform surgery during the trial or within 3 months after the end of the trial (including cosmetic surgery, dental and oral surgery).
Outcomes
Primary Outcomes
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time Frame: 14 days after the second vaccination
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time Frame: 14 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Adverse reactions/events rate
Time Frame: 28 days after vaccination
Occurence of adverse reactions/events after vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Secondary Outcomes
- Serious adverse events(12 months after the second vaccination)
- Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)(7, 14 and 28 days after the second vaccination)
- Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)(14 and 28 days after the second vaccination)
- Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)(7 and 28 days after the second vaccination)
- Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)(14 days after the second vaccination)
- Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)(14 days after the second vaccination)
- Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)(28 days after the second vaccination)
- Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)(14 and 28 days after the second vaccination)
- Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)(7, 14 and 28 days after the second vaccination)
- Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)(7 and 28 days after the second vaccination)
- Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)(28 days after the second vaccination)
- Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)(28 days after the second vaccination)
- Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)(28 days after the second vaccination)