A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)
A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above
1 other identifier
interventional
960
1 country
1
Brief Summary
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Nov 2020
Typical duration for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 17, 2020
CompletedFirst Submitted
Initial submission to the registry
November 19, 2020
CompletedFirst Posted
Study publicly available on registry
November 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2021
CompletedJune 1, 2022
March 1, 2022
3 months
November 19, 2020
May 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Geometric mean (GMT) of specific antibody
Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA)
1 months after immunization in each study group
The incidence of adverse reaction (AR)
The incidence of adverse reaction (AR)
0 to 7 days after vaccination in each study group
Secondary Outcomes (9)
The incidence of adverse events (AE)
0 to 28 days after vaccination in each study group
The incidence of severe adverse events (SAE)
0 to 28 days after vaccination in each study group
The incidence of serious adverse events
6 months after vaccination in each study group
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies
1 months after immunization in each study group
The positive conversion rate of S-RBD protein-specific antibody
14 days, 30 days after immunization in each study group
- +4 more secondary outcomes
Other Outcomes (4)
The consistency analysis of the specific antibody and the specific neutralizing antibody
1 months after immunization in each study group
The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
1 months after immunization in each study group
The persistence (GMT，GMI，positive conversion rate) of specific antibodies
6 months after vaccination in each study group
- +1 more other outcomes
Study Arms (16)
Low-dose vaccine (18-59 years) & Two dose regimen
EXPERIMENTALtwo doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Low-dose vaccine (18-59 years) & Three dose regimen
EXPERIMENTALthree doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
High-dose vaccine (18-59 years) & Two dose regimen
EXPERIMENTALtwo doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
High-dose vaccine (18-59 years) & Three dose regimen
EXPERIMENTALthree doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Low-dose vaccine (60-85 years) & Two dose regimen
EXPERIMENTALtwo doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Low-dose vaccine (60-85 years) & Three dose regimen
EXPERIMENTALthree doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
High-dose vaccine (60-85 years) & Two dose regimen
EXPERIMENTALtwo doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
High-dose vaccine (60-85 years) & Three dose regimen
EXPERIMENTALthree doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Low-dose placebo (18-59 years) & Two dose regimen
PLACEBO COMPARATORtwo doses of placebo at the schedule of day 0, 21.
Low-dose placebo (18-59 years) & Three dose regimen
PLACEBO COMPARATORthree doses of placebo at the schedule of day 0, 14, 28.
High-dose placebo (18-59 years) & Two dose regimen
PLACEBO COMPARATORtwo doses of placebo at the schedule of day 0, 21.
High-dose placebo (18-59 years) & Three dose regimen
PLACEBO COMPARATORthree doses of placebo at the schedule of day 0, 14, 28.
Low-dose placebo (60-85 years) & Two dose regimen
PLACEBO COMPARATORtwo doses of placebo at the schedule of day 0, 21.
Low-dose placebo (60-85 years) & Three dose regimen
PLACEBO COMPARATORthree doses of placebo at the schedule of day 0, 14, 28.
High-dose placebo (60-85 years) & Two dose regimen
PLACEBO COMPARATORtwo doses of placebo at the schedule of day 0, 21.
High-dose placebo (60-85 years) & Three dose regimen
PLACEBO COMPARATORthree doses of placebo at the schedule of day 0, 14, 28.
Interventions
18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
Eligibility Criteria
You may qualify if:
- Aged 18 years and above.
- Able to understand the content of informed consent and willing to sign the informed consent.
- Able and willing to complete all the secluded study process during the whole study follow-up period (about 7 months).
- Axillary temperature ≤37.0℃.
- General good health as established by medical history and physical examination.
You may not qualify if:
- Positive serum immunoglobulin M (IgM) and IgG to the SARS-CoV-2.
- A Known History of HIV infection
- Family history of seizure, epilepsy, brain or mental disease.
- Participant that has an allergic history to any ingredient of vaccines.
- Woman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months.
- Any acute fever disease or infections.
- Have a medical history of SARS.
- Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled.
- Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled.
- Hereditary angioneurotic edema or acquired angioneurotic edema.
- Urticaria in last one year.
- Asplenia or functional asplenia.
- Platelet disorder or other bleeding disorder may cause injection contraindication.
- Faint at the sight of blood or needles.
- Prior administration of immunodepressant or corticosteroids, antianaphylactics treatment, cytotoxic treatment in last 6 months.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengcai Zhu, Doctor
Jiangsu Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2020
First Posted
November 23, 2020
Study Start
November 17, 2020
Primary Completion
February 18, 2021
Study Completion
November 23, 2021
Last Updated
June 1, 2022
Record last verified: 2022-03