Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Adult Group 1a

Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low adjuvant dose at Day 0 and Day 28

Group Type EXPERIMENTAL

202-CoV low adjuvant dose

Intervention Type BIOLOGICAL

standard dose of 202-CoV with low dose CpG / alum adjuvant

Adult Group 1b

Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low antigen dose at Day 0 and Day 28

Group Type EXPERIMENTAL

202-CoV low antigen dose

Intervention Type BIOLOGICAL

low dose 202-CoV with CpG / alum adjuvant

Adult Group 1c

Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV standard dose at Day 0 and Day 28

Group Type EXPERIMENTAL

202-CoV standard dose

Intervention Type BIOLOGICAL

standard dose 202-CoV with CpG / alum adjuvant

Adult Placebo

Adult healthy subjects (18 to 59 years of age, inclusive) receive 2 doses of placebo (saline) at Day 0 and Day 28

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Normal saline solution

Elderly Group 1d

Adult healthy subjects (60 years of age and above) receive 202-CoV low adjuvant dose at Day 0 and Day 28

Group Type EXPERIMENTAL

202-CoV low adjuvant dose

Intervention Type BIOLOGICAL

standard dose of 202-CoV with low dose CpG / alum adjuvant

Elderly Group 1e

Adult healthy subjects (60 years of age and above) receive 202-CoV low antigen dose at Day 0 and Day 28

Group Type EXPERIMENTAL

202-CoV low antigen dose

Intervention Type BIOLOGICAL

low dose 202-CoV with CpG / alum adjuvant

Elderly Group 1f

Adult healthy subjects (60 years of age and above) receive 202-CoV standard dose at Day 0 and Day 28

Group Type EXPERIMENTAL

202-CoV standard dose

Intervention Type BIOLOGICAL

standard dose 202-CoV with CpG / alum adjuvant

Elderly Placebo

Adult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Normal saline solution

Interventions

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202-CoV low adjuvant dose

standard dose of 202-CoV with low dose CpG / alum adjuvant

Intervention Type BIOLOGICAL

202-CoV low antigen dose

low dose 202-CoV with CpG / alum adjuvant

Intervention Type BIOLOGICAL

202-CoV standard dose

standard dose 202-CoV with CpG / alum adjuvant

Intervention Type BIOLOGICAL

Placebo

Normal saline solution

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes