A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18~59 Years
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Sinovac Research and Development Co., Ltd.
- Enrollment
- 744
- Locations
- 1
- Primary Endpoint
- Safety indexes of adverse reactions
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ/Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.
Detailed Description
This study is a randomized, double-blinded, single-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged 18\~59 years. The purpose of this study is to evaluate the immunogenicity and safety of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 744 subjects will be enrolled, with 144 at phase Ⅰ, and 600 at phase Ⅱ. All of participants in phase Ⅰ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28.300 participants in phase Ⅱ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28 and one dose of booster immunization will be given 6 months after primary immunization of day 0,14 or day 0,28.The other 300 participants in phase Ⅱ will be assigned to receive three doses of experimental vaccine or placebo on the schedule of day 0,14,42 or 0,28,56 .
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults aged 18-59 years;
- •Proven legal identity;
- •Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;
Exclusion Criteria
- •Travel history / residence history of Wuhan city and surrounding areas, or other communities with case reports within 14 days;
- •History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
- •Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
- •Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
- •Self-reported history of SARS;
- •Self-reported history of new coronavirus infection;
- •Positive in serum antibodies (IgG or IgM) screening of COVID-19;
- •Positive in nasopharyngeal swabs or anal swabs through RT-PCR;
- •Women who are breastfeeding, pregnant or planning to become pregnant during the study period;
- •BMI≥35 kg/m2;
Outcomes
Primary Outcomes
Safety indexes of adverse reactions
Time Frame: From Day 0 to Day 28 after each dose
Incidence of adverse reactions occured from Day 0 to Day 28 after each dose
Immunogenicity indexes of neutralizing-antibody seroconversion rates
Time Frame: The 14th day /the 28th day after two doses of vaccination
The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.
Secondary Outcomes
- Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase Ⅱ(14 day (emergency schedule)/28 days (routine schedule) after the booster dose （only for days 0,14 and days 0,28 schedule）)
- Safety indexes of adverse reactions(7 days after each dose of vaccination)
- Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅱ(28 days after the third dose （only for days 0,14,42 and days 0,28,56 schedule）)
- Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies(7/14/21/28/42 days after the first dose vaccination (emergency schedule))
- Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies(28/35/42/56 days after the first dose vaccination (routine schedule))
- Safety indexes of serious adverse events (SAEs）(From the beginning of the vaccination to 6 months post the whole-schedule vaccination)
- Safety indexes of Incidence of abnormal laboratory index(On the 3th day after each dose of vaccination in phase Ⅰ)
- Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies(14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination)
- Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies(28 days after the two doses (emergency schedule))
- Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ(28/35/42 days after the first dose vaccination (routine schedules))