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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Placebo; Biological: 202-CoV low adjuvant dose; Biological: 202-CoV low antigen dose; Biological: 202-CoV standard dose

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Xuchang, China
    • Xiangcheng Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Adult Placebo; Adult healthy subjects (18 to 59 years of age, inclusive) receive 2 doses of placebo (saline) at Day 0 and Day 28	Other: Placebo; Normal saline solution
Placebo Comparator: Elderly Placebo; Adult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28	Other: Placebo; Normal saline solution
Experimental: 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	Biological: 202-CoV low adjuvant dose; standard dose of 202-CoV with low dose CpG / alum adjuvant
Experimental: 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	Biological: 202-CoV low antigen dose; low dose 202-CoV with CpG / alum adjuvant
Experimental: Adult Group 1c; Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV standard dose at Day 0 and Day 28	Biological: 202-CoV standard dose; standard dose 202-CoV with CpG / alum adjuvant
Experimental: Elderly Group 1d; Adult healthy subjects (60 years of age and above) receive 202-CoV low adjuvant dose at Day 0 and Day 28	Biological: 202-CoV low adjuvant dose; standard dose of 202-CoV with low dose CpG / alum adjuvant
Experimental: Elderly Group 1e; Adult healthy subjects (60 years of age and above) receive 202-CoV low antigen dose at Day 0 and Day 28	Biological: 202-CoV low antigen dose; low dose 202-CoV with CpG / alum adjuvant
Experimental: Elderly Group 1f; Adult healthy subjects (60 years of age and above) receive 202-CoV standard dose at Day 0 and Day 28	Biological: 202-CoV standard dose; standard dose 202-CoV with CpG / alum adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of solicited adverse events (AEs) after vaccination	Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 28) by intensity, relevance.	7 days after the first or second vaccination
Incidence of unsolicited AEs after vaccination	Percentage of participants with unsolicited AEs for 28 days following each vaccination	Frame: Day 0 to Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)	Percentage of participants with SAEs or AESI for 12month after last dose vaccination	Day 0 to Month 13
Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis and coagulation parameters	Safety Laboratory Values (Serum Chemistry, Hematology)	Day 4 after first or second vaccination
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies	Neutralizing antibody activity as detected by neutralization assay expressed as GMTs at multiple time points through Day 56	Day0, Day28, Day42 and Day56
Seroconversion rate (SCR) of SARS-CoV-2 neutralising antibodies	Neutralizing antibody activity as detected by neutralization assay expressed as seroconversion rate at multiple time points through Day 56	Day0, Day28, Day42 and Day56
Geometric mean titer (GMT) of Serum IgG Antibody Levels	Serum IgG antibody levels specific for the SARS-CoV-2 S protein antigen as detected by ELISA expressed as GMTs at multiple time points through Day 56	Day0, Day28, Day42 and Day56
Seroconversion rate (SCR) of Serum IgG Antibody Levels	Serum IgG antibody levels specific for the SARS-CoV-2 S protein antigen as detected by ELISA expressed as seroconversion rate at multiple time points through Day 56	Day0, Day28, Day42 and Day56

Collaborators and Investigators

• Sponsor: Shanghai Zerun Biotechnology Co.,Ltd
• Collaborators: Walvax Biotechnology Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 202-COV-1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No