Clinical trial NCT04982068: Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19
Official title: A Randomized, Double-blinded, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Immunogenicity of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy Adults Aged 18 Years and Above
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Shanghai Zerun Biotechnology Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Walvax Biotechnology Co., Ltd.
First posted: 2021-07-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and preliminary immunogenicity of 202-CoV at multiple dose levels, administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age and above.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals aged 18-59 years as well as 60 years and above who can provide legal identification (males and females are both required).
* Willing to participate in the study with informed consent prior to screening
* Negative in SARS-CoV-2 IgG and IgM test at screening.
* Women of childbearing potential must be using effective method of birth control for 14 days prior to the enrollment of the study vaccine/placebo and must agree to continue such precautions during the study until 30 days after the second dose of the study vaccine/placebo.
* Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 30 days after the second dose of the study vaccine/placebo.

Exclusion Criteria:

* Confirmed or asymptomatic COVID-19 cases or SARS-CoV-2 infection(had positive in SARS-CoV-2 nucleic acid test or serological test).
* Had a history of traveling or residence in domestic area of high and moderate pandemic risk, overseas or epidemic areas, or had a history of contact with confirmed, asymptomatic or suspected COVID-19 cases within the past 14 days;
* History of SARS;
* Received SARS-CoV-2 vaccines for emergency use or approved SARS-CoV-2 vaccines;
* Individuals involving a clinical study within 6 months prior to the screening visit; or planning to participate in another clinical study during study period.
* Clinical laboratory abnormalities and with clinical significance judged by investigator
* Individual's systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 100mmHg at screening visit
* Axillary temperature \>=37.3℃ prior to vaccination
* Individuals in other acute diseases, or in the acute phase of chronic diseases within 3 days prior to the signing of the informed consent form.
* Received immunoglobulin and/or blood product 3 months prior to the first vaccination.
* Presence of uncontrolled chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a high-risk category for SARS-CoV-2 infection and/or its complications as judged by the investigator..
* Individuals with a history of severe allergic reaction (throat swelling, difficult in breath, dyspnea, or shock).
* Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction \[e.g., anaphylaxis to any component of the study vaccines (S protein, Aluminum hydroxide, CpG adjuvant).
* Any autoimmune or immunodeficiency disease/condition \[e.g. human immunodeficiency virus (HIV) infection, Systemic lupus erythematosus (SLE)\]
* Received immunoglobulin, blood-derived products within 3 months prior to the first study vaccination.
* Abnormal coagulation function (such as coagulation factor deficiency, coagulation disease, platelet abnormality) obvious bruises or coagulopathy.
* Pregnant women or breastfeeding women.
* According to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.

Primary outcomes:
measure: Incidence of solicited adverse events (AEs) after vaccination
timeFrame: 7 days after the first or second vaccination
measure: Incidence of unsolicited AEs after vaccination
timeFrame: Frame: Day 0 to Day 56
Secondary outcomes:
measure: Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
timeFrame: Day 0 to Month 13
measure: Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis and coagulation parameters
timeFrame: Day 4 after first or second vaccination
measure: Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies
timeFrame: Day0, Day28, Day42 and Day56
measure: Seroconversion rate (SCR) of SARS-CoV-2 neutralising antibodies
timeFrame: Day0, Day28, Day42 and Day56
measure: Geometric mean titer (GMT) of Serum IgG Antibody Levels
timeFrame: Day0, Day28, Day42 and Day56
measure: Seroconversion rate (SCR) of Serum IgG Antibody Levels
timeFrame: Day0, Day28, Day42 and Day56
Other outcomes:
Locations:
city: Xuchang
country: China
facility: Xiangcheng Center for Disease Control and Prevention
Study officials:
References:
citation: Liu H, Zhou C, An J, Song Y, Yu P, Li J, Gu C, Hu D, Jiang Y, Zhang L, Huang C, Zhang C, Yang Y, Zhu Q, Wang D, Liu Y, Miao C, Cao X, Ding L, Zhu Y, Zhu H, Bao L, Zhou L, Yan H, Fan J, Xu J, Hu Z, Xie Y, Liu J, Liu G. Development of recombinant COVID-19 vaccine based on CHO-produced, prefusion spike trimer and alum/CpG adjuvants. Vaccine. 2021 Nov 26;39(48):7001-7011. doi: 10.1016/j.vaccine.2021.10.066. Epub 2021 Oct 30.