Phase I Trial of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell)
Safety, Tolerability and Immunogenicity of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell) in Chinese Healthy Population Aged 18 Years and Older: A Phase I, Single-center, Randomized, Placebo-controlled, Double-blind Study
1 other identifier
interventional
168
1 country
1
Brief Summary
This is a phase I, single-center, randomized, placebo-controlled, double-blind study, to evaluate safety, tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine (Sf9 cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (Sf9 Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 28 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 55 years old will be enrolled in adult group, and healthy elderly population who are \>55 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.
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 Aug 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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedStudy Start
First participant enrolled
August 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2021
CompletedJune 1, 2022
March 1, 2022
2 months
August 27, 2020
May 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of adverse reactions (AR) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
Occurrence of solicited AR in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
7 days after each dose.
Secondary Outcomes (12)
Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
7 days after each dose.
Occurrence of AE up to Day 28 after prime and boost vaccination.
Day 28 after prime and boost vaccination.
The proportion of SAEs up to Day 28 after prime and boost vaccination.
Day 28 after prime and boost vaccination.
The proportion of SAEs up to Month 12 after prime and boost vaccination.
The proportion of subjects experiencing SAEs up to Month 12 after prime and boost vaccination.
The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
7 days before prime vaccination and Day 3 after each dose.
- +7 more secondary outcomes
Study Arms (12)
Middle-dose vaccine (18-55 years) & Two dose regimen
EXPERIMENTALTwo doses of middle-dose experimental vaccine at the schedule of day 0, 28.
Middle-dose vaccine (> 55 years) & Two dose regimen
EXPERIMENTALTwo doses of middle-dose experimental vaccine at the schedule of day 0, 28.
High-dose vaccine (18-55 years) & Two dose regimen
EXPERIMENTALTwo doses of high-dose experimental vaccine at the schedule of day 0, 28.
High-dose vaccine (> 55 years) & Two dose regimen
EXPERIMENTALTwo doses of high-dose experimental vaccine at the schedule of day 0, 28.
High-dose vaccine (18-55 years) & Three dose regimen
EXPERIMENTALThree doses of high-dose experimental vaccine at the schedule of day 0, 14, 28.
High-dose vaccine (> 55 years) & Three dose regimen
EXPERIMENTALThree doses of high-dose experimental vaccine at the schedule of day 0, 14, 28.
Middle-dose placebo (18-55 years) & Two dose regimen
PLACEBO COMPARATORTwo doses of middle-dose placebo at the schedule of day 0, 28.
Middle-dose placebo (> 55 years) & Two dose regimen
PLACEBO COMPARATORTwo doses of middle-dose placebo at the schedule of day 0, 28.
High-dose placebo (18-55 years) & Two dose regimen
PLACEBO COMPARATORTwo doses of high-dose placebo at the schedule of day 0, 28.
High-dose placebo (> 55 years) & Two dose regimen
PLACEBO COMPARATORTwo doses of high-dose placebo at the schedule of day 0, 28.
High-dose placebo (18-55 years) & Three dose regimen
PLACEBO COMPARATORThree doses of high-dose placebo at the schedule of day 0, 14, 28.
High-dose placebo (> 55 years) & Three dose regimen
PLACEBO COMPARATORThree doses of high-dose placebo at the schedule of day 0, 14, 28.
Interventions
Two doses of middle-dose (20µg/ 0.5ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
Two doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
Three doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
Two doses of placebo (0.5ml) at the schedule of day 0, 28
Two doses of placebo (1.0ml) at the schedule of day 0, 28
Three doses of placebo (1.0ml) at the schedule of day 0, 14, 28
Eligibility Criteria
You may qualify if:
- Male or female subjects of ≥ 18 years old with body mass index (BMI) ≥ 18.5 and ≤ 30 at the Screening Visit.
- The subject can provide with informed consent and signs and dates a written informed consent form (ICF) prior to the initiation of any trial procedures.
- They must be able to understand and follow trial-related instructions.
- They must be willing and able to comply with planned visits, treatment schedule, laboratory tests and other requirements of the trial.
- Negative HIV antibody when screening.
- Axillary temperature ≤ 37.0ºC.
- Negative in nucleic acid screening of SARS-CoV-2.
- Negative in antibodies (IgG and IgM) screening of SARS-CoV-2.
- No imaging features of COVID-19 in chest CT.
- There were no significant abnormalities in blood routine, blood biochemistry, coagulation function and urine routine, or no clinical significance was determined by doctors (including white blood cell count, lymphocyte count, neutrophil count, platelet, hemoglobin, glutamic pyruvic transaminase ALT, glutamic oxaloacetic transaminase AST, total bilirubin, fasting blood glucose, creatinine, prothrombin time, partially activated prothrombin time, urine protein, urine red blood cells).
- Healthy subjects who have been examined by medical history, physical examination and clinical examination are in accordance with the immunization of this vaccine.
You may not qualify if:
- Subjects with a medical or family history of convulsions, epilepsy, encephalopathy, and psychosis.
- Allergic to any ingredient in the study vaccine, or used to have a serious vaccine allergic reaction.
- Women who are positive for urine pregnancy test. Women who are pregnant or breastfeeding or planning to be pregnant within 6 months.
- Have acute febrile diseases or infectious diseases.
- History of SARS, SARS-CoV-2 or MERS infection.
- People with serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and can not control using drugs.
- Patients with severe chronic diseases or progressive conditions can not be smoothly controlled, such as asthma, diabetes, and thyroid diseases.
- Have congenital or acquired angioedema/neuroedema.
- Had urticaria 1 year before receiving the study vaccine.
- Asplenium or functional aspleen.
- Have thrombocytopenia or other coagulation disorders (may cause contraindications to intramuscular injection).
- Have acupuncture syncope reaction.
- Have received immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis).
- Received blood products within 4 months before receiving the study vaccine.
- Received other study drugs within 1 month before receiving the study vaccine.
- +7 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
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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2020
First Posted
August 28, 2020
Study Start
August 28, 2020
Primary Completion
October 28, 2020
Study Completion
November 23, 2021
Last Updated
June 1, 2022
Record last verified: 2022-03