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

NCT04982068 | Unknown Phase 1 DMC

• 1 other identifier: 202-COV-1001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)

  Day 0 to Month 13

• Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis and coagulation parameters

  Day 4 after first or second vaccination

• Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies

  Day0, Day28, Day42 and Day56

• Seroconversion rate (SCR) of SARS-CoV-2 neutralising antibodies

  Day0, Day28, Day42 and Day56

• Geometric mean titer (GMT) of Serum IgG Antibody Levels

  Day0, Day28, Day42 and Day56

Study Arms (8)

Adult Group 1a

EXPERIMENTAL

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

Adult Group 1b

EXPERIMENTAL

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

Adult Group 1c

EXPERIMENTAL

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

Adult Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Elderly Group 1d

EXPERIMENTAL

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

Elderly Group 1e

EXPERIMENTAL

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

Elderly Group 1f

EXPERIMENTAL

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

Elderly Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

202-CoV low adjuvant dose BIOLOGICAL

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

Adult Group 1a; Elderly Group 1d

202-CoV low antigen dose BIOLOGICAL

low dose 202-CoV with CpG / alum adjuvant

Adult Group 1b; Elderly Group 1e

202-CoV standard dose BIOLOGICAL

standard dose 202-CoV with CpG / alum adjuvant

Adult Group 1c; Elderly Group 1f

Placebo OTHER

Normal saline solution

Adult Placebo; Elderly Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zerun Biotechnology Co.,Ltd: lead
• Walvax Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Xiangcheng Center for Disease Control and Prevention

Xuchang, China

Location

Related Publications (1)

• 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.

  PMID: 34750014 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 29, 2021
• Study Start: July 12, 2021
• Primary Completion: October 31, 2021
• Study Completion: June 1, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

CN (1)