Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
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
1 other identifier
interventional
744
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Apr 2020
Typical duration for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2020
CompletedStudy Start
First participant enrolled
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2021
CompletedFebruary 24, 2022
July 1, 2021
3 months
April 14, 2020
February 22, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Safety indexes of adverse reactions
Incidence of adverse reactions occured from Day 0 to Day 28 after each dose
From Day 0 to Day 28 after each dose
Immunogenicity indexes of neutralizing-antibody seroconversion rates
The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.
The 14th day /the 28th day after two doses of vaccination
Secondary Outcomes (11)
Safety indexes of adverse reactions
7 days after each dose of vaccination
Safety indexes of Incidence of abnormal laboratory index
On the 3th day after each dose of vaccination in phase Ⅰ
Safety indexes of serious adverse events (SAEs）
From the beginning of the vaccination to 6 months post the whole-schedule vaccination
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)
- +6 more secondary outcomes
Study Arms (12)
Emergency schedule & Two doses of medium dosage vaccine
EXPERIMENTAL24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the emergency schedule
Emergency schedule & Two doses of high dosage vaccine
EXPERIMENTAL24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the emergency schedule
Emergency schedule &Two doses of placebo
PLACEBO COMPARATOR24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the emergency vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the emergency schedule
Routine schedule & Two doses of medium dosage vaccine
EXPERIMENTAL24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the routine schedule
Routine schedule &Two doses of high dosage vaccine
EXPERIMENTAL24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the routine schedule
Routine schedule & Two doses of placebo
PLACEBO COMPARATOR24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the routine vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the routine schedule
Emergency schedule & Three doses of medium dosage vaccine
EXPERIMENTAL60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Emergency schedule & Three doses of high dosage vaccine
EXPERIMENTAL60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Emergency schedule &Three doses of placebo
PLACEBO COMPARATOR30 participants in phase Ⅱ will receive three doses of placebo at the emergency vaccination schedule
Routine schedule & Three doses of medium dosage vaccine
EXPERIMENTAL60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Routine schedule &Three doses of high dosage vaccine
EXPERIMENTAL60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Routine schedule &Three doses of placebo
PLACEBO COMPARATOR30 participants in phase Ⅱ will receive three doses of placebo at the routine vaccination schedule
Interventions
Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
Two doses of placebo at the schedule of day 0,14 and one dose of booster immunization with placebo 6 months after the schedule of day 0,14 in phaseⅡ.
Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ.
Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ
Two doses of placebo at the schedule of day 0,28 and one dose of booster immunization with placebo 6 months after the schedule of day 0,28 in phaseⅡ.
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Three doses of placebo at the schedule of day 0,14,42
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Three doses of placebo at the schedule of day 0,28,56
Eligibility Criteria
You may qualify if:
- 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 ;
You may not qualify if:
- 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;
- History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Autoimmune disease or immunodeficiency / immunosuppression;
- Suffering from severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, 221200, China
Related Publications (3)
Xin Q, Wu Q, Chen X, Han B, Chu K, Song Y, Jin H, Chen P, Lu W, Yang T, Li M, Zhao Y, Pan H, Yu H, Wang L. Six-month follow-up of a booster dose of CoronaVac in two single-centre phase 2 clinical trials. Nat Commun. 2022 Jun 3;13(1):3100. doi: 10.1038/s41467-022-30864-w.
PMID: 35660738DERIVEDZeng G, Wu Q, Pan H, Li M, Yang J, Wang L, Wu Z, Jiang D, Deng X, Chu K, Zheng W, Wang L, Lu W, Han B, Zhao Y, Zhu F, Yu H, Yin W. Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials. Lancet Infect Dis. 2022 Apr;22(4):483-495. doi: 10.1016/S1473-3099(21)00681-2. Epub 2021 Dec 8.
PMID: 34890537DERIVEDZhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.
PMID: 33217362DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengcai Zhu, Doctor
Jiangsu Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2020
First Posted
April 20, 2020
Study Start
April 16, 2020
Primary Completion
July 10, 2020
Study Completion
July 24, 2021
Last Updated
February 24, 2022
Record last verified: 2021-07