Phase I Trial of a Recombinant COVID-19 Vaccine (CHO Cell)
Safety and Immunogenicity of a Recombinant COVID-19 Vaccine (CHO Cell) in Healthy Population Aged 18 Years and Older: A Phase I Study
1 other identifier
interventional
216
1 country
1
Brief Summary
This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO 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 (CHO Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 14 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 ≤ 59 years old will be enrolled in adult group, and healthy elderly population who are \>59 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 Oct 2020
Longer than P75 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
Study Start
First participant enrolled
October 30, 2020
CompletedFirst Submitted
Initial submission to the registry
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2022
CompletedMarch 31, 2022
March 1, 2022
1.1 years
November 17, 2020
March 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of adverse reactions (AR) up to Day 28 after prime and boost vaccination of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.
28 days after first dose
Secondary Outcomes (7)
The proportion of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.
7 days after each dose
The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 3 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo
3 days after each dose
The proportion of serious adverse events up to Month 12 after prime and boost vaccination.
Month 12 after prime and boost vaccination
The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GMI at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#
Day 14, Day 21, Day 28, Day 42 after prime vaccination
The proportion of IgG antibody positive rate at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#
Day 14, Day 21, Day 28, Day 42 after prime vaccination
- +2 more secondary outcomes
Other Outcomes (5)
The proportion of IFN-γ secreted by T cells at Day 14 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo using ELISpot detection method
Day 14 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo
Changes in serum cytokine (IL2, IL6) levels from baseline after 3 days of each dose
3 days of each dose
The proportion of neutralizing antibody and the GMT up to Month 3 after the whole process of vaccination
Month 3 after the whole process of vaccination
- +2 more other outcomes
Study Arms (12)
Middle-dose vaccine (18-59 years) & Two dose regimen
EXPERIMENTALTwo doses of middle-dose experimental vaccine at the schedule of day 0, 14.
Middle-dose vaccine (18-59 years) & Three dose regimen
EXPERIMENTALThree doses of middle-dose experimental vaccine at the schedule of day 0, 14 28.
High-dose vaccine (18-59 years) & Two dose regimen
EXPERIMENTALTwo doses of high-dose experimental vaccine at the schedule of day 0, 14.
High-dose vaccine (18-59 years) & Three dose regimen
EXPERIMENTALTwo doses of High-dose vaccine at the schedule of day 0, 14, 28.
Middle-dose vaccine (> 59 years) & Three dose regimen
EXPERIMENTALThree doses of middle-dose experimental vaccine at the schedule of day 0, 14, 28.
High-dose vaccine (> 59 years) & Three dose regimen
EXPERIMENTALThree doses of high-dose experimental vaccine at the schedule of day 0, 14, 28.
Middle-dose placebo (18-59 years) & Two dose regimen
PLACEBO COMPARATORTwo doses of middle-dose placebo at the schedule of day 0, 14.
Middle-dose placebo (18-59 years) & Three dose regimen
PLACEBO COMPARATORThree doses of middle-dose placebo at the schedule of day 0, 14, 28.
High-dose placebo (18-59 years) & Two dose regimen
PLACEBO COMPARATORTwo doses of high-dose placebo at the schedule of day 0, 14.
High-dose placebo (18-59 years) & Three dose regimen
PLACEBO COMPARATORThree doses of high-dose placebo at the schedule of day 0, 14, 28.
Middle-dose placebo (> 59 years) & Three dose regimen
PLACEBO COMPARATORThree doses of high-dose placebo at the schedule of day 0, 14, 28.
High-dose placebo (> 59 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 (CHO Cell) at the schedule of day 0, 14.
Three doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.
Two doses of high-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHOCell) at the schedule of day 0, 14.
Three doses of middle-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.
Two doses of placebo (0.5ml) at the schedule of day 0, 14.
Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.
Two doses of placebo (0.5ml) at the schedule of day 0, 14.
Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.
Eligibility Criteria
You may qualify if:
- Healthy subjects of ≥ 18 years old.
- The subject can understand and voluntarily sign the informed consent.
- The subject can The subject canprovide legal identification.
You may not qualify if:
- Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomatic infection in the previous 14 days, or a travel history/residential history in a community where a case has been reported.
- Have a history of contact with a person infected with SARS-CoV-2(a person with a positive nucleic acid test) in the previous 14 days.
- Patients with fever or respiratory symptoms who have been to middle or high-risk areas in the past 14 days or have exit history, or come from communities with case reports.
- In the past 14 days, there have been 2 or more cases of fever and/or respiratory symptoms in small areas such as homes, offices, school classes, etc.
- Have a history of SARS.
- Have a history of SARS-CoV-2 infection.
- Positive in SARS-CoV-2 IgG or IgM antibody screening.
- Positive in RT-PCR test of SARS-CoV-2 in throat swab.
- Positive in HIVantibody screening.
- Women who are breastfeeding, pregnant, or planning to become pregnant during the study period (based on the subject's self-report and blood pregnancy test results for women of childbearing age), or men who plan to conceive their partners during the study period.
- Subjects with body mass index (BMI) ≥35 kg/m2.
- Have a history of asthma, a history of vaccine or vaccine component allergy, have serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema.
- Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Subjects with autoimmune diseases or immunodeficiency/immunosuppression.
- Subjects with severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.
- +29 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Related Publications (1)
Luo D, Pan H, He P, Yang X, Li T, Ning N, Fang X, Yu W, Wei M, Gao H, Wang X, Gu H, Mei M, Li X, Zhang L, Li D, Gao C, Gao J, Fei G, Li Y, Yang Y, Xu Y, Wei W, Sun Y, Zhu F, Hu Z, Wang H. A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults. Clin Transl Med. 2022 Sep;12(9):e1016. doi: 10.1002/ctm2.1016.
PMID: 36103390DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengcai Zhu, Doctor
Jiangsu Provincial Center for Disease Control and Prevention
Central Study Contacts
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
November 17, 2020
First Posted
November 19, 2020
Study Start
October 30, 2020
Primary Completion
December 7, 2021
Study Completion
July 7, 2022
Last Updated
March 31, 2022
Record last verified: 2022-03