NCT04869592

Brief Summary

phase I study will evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 3 years and older. 300 subjects will be enrolled and divided into 5 age groups: 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group and 3-8 years old group. In each group, there are two regimen cohort: low-dose at 0,30, 60 schedule and high-dose at 0,30,60 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1. Phase II clinical study will explore dose and immunization procedures in 5 age groups, including 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group, and 3-8 years old group, with a total of 3280 subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,100

participants targeted

Target at P75+ for phase_1 covid19

Timeline
Completed

Started Apr 2021

Longer than P75 for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 24, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2023

Completed
Last Updated

January 16, 2026

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

April 24, 2021

Last Update Submit

January 15, 2026

Conditions

COVID-19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (19)

  • the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination

    Phase 1

    through 30 minutes after each dose

  • the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine on the 4th day after each dose of vaccination

    Phase 1

    4th day each dose

  • the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination

    Phase 1

    through 7 days after each dose

  • the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination

    Phase 1

    through 30 days after each dose

  • the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination

    Phase 1

    through 30 days after each dose

  • the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination

    Phase 1

    up to 12 months after the full course of vaccination

  • the incidence of AESI from the first dose of vaccination to 12 months after the full course of vaccination

    Phase 1

    up to 12 months after the full course of vaccination

  • Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody(wild Strains) on the 15th day after the full course of vaccination

    Phase 1

    15th day after the full course of vaccination

  • the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination

    Phase 2

    through 30 minutes after each dose

  • the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination

    Phase 2

    through 7 days after each dose

  • the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination

    Phase 2

    through 30 days after each dose

  • the incidence and severity of non-collective adverse reactions/events within 40 days after each dose of vaccination

    Phase 2

    through 40 days after each dose

  • the incidence and severity of non-collective adverse reactions/events within 60 days after each dose of vaccination

    Phase 2

    through 60 days after each dose

  • the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination

    Phase 2

    through 30 days after each dose

  • the incidence and severity of adverse events leading to withdrawal within 40 days after each dose of vaccination

    Phase 2

    through 40 days after each dose

  • the incidence and severity of adverse events leading to withdrawal within 60 days after each dose of vaccination

    Phase 2

    through 60 days after each dose

  • the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination

    Phase 2

    up to 12 months after the full course of vaccination

  • the incidence of AESI from the the first dose of vaccination to 12 months after the full course of vaccination

    Phase 2

    up to 12 months after the full course of vaccination

  • Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody (wild Strains) on the 15th day after the full course of vaccination

    Phase 2

    15th day after the full course of vaccination

Secondary Outcomes (11)

  • Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Live SARS-CoV-2 neutralization assay) On the 30th day after the full course of vaccination, the neutralizing antibody level (wild Strains)

    30th day after the full course of vaccination

  • Seroconversion and Geometric Mean Titer (GMT) of SARS-CoV-2-Specific Binding Antibody (IgG) Before each dose, the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after full course of vaccination

    before each dose , the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination

  • Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Pseudovirus neutralization assay) in the 18-59 years old group before each dose and on the 15th and 30th day after the full course of vaccination

    before each dose，the 15th, 30th day after the full course of vaccination

  • Geometric Mean Titer (GMT) of SARS-COV-2 specific neutralizing antibody (live SARS-CoV-2 neutralization assay)) On the 30th day after the full course of vaccination

    30th day after the full course of vaccination

  • Two-dose group: the neutralizing antibody levels (live SARS-CoV-2 neutralization assay) before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination

    before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination

  • +6 more secondary outcomes

Study Arms (15)

Phase 1 low-dose group

EXPERIMENTAL
Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Phase 1 high-dose group

EXPERIMENTAL
Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Phase 1 placebo group

PLACEBO COMPARATOR
Biological: placebo

Phase 2 low-dose group A

EXPERIMENTAL
Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Phase 2 low-dose group B

EXPERIMENTAL
Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Phase 2 low-dose group C

EXPERIMENTAL
Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Phase 2 low-dose group D

EXPERIMENTAL
Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Phase 2 high-dose group A

EXPERIMENTAL
Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Phase 2 high-dose group B

EXPERIMENTAL
Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Phase 2 high-dose group C

EXPERIMENTAL
Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Phase 2 high-dose group D

EXPERIMENTAL
Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Phase 2 placebo group A

PLACEBO COMPARATOR
Biological: placebo

Phase 2 placebo group B

PLACEBO COMPARATOR
Biological: placebo

Phase 2 placebo group C

PLACEBO COMPARATOR
Biological: placebo

Phase 2 placebo group D

PLACEBO COMPARATOR
Biological: placebo

Interventions

placeboBIOLOGICAL

Intramuscular injection of placebo in the deltoid muscle of the upper arm

Phase 1 placebo groupPhase 2 placebo group APhase 2 placebo group BPhase 2 placebo group CPhase 2 placebo group D
low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)BIOLOGICAL

Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm

Phase 1 low-dose groupPhase 2 low-dose group APhase 2 low-dose group BPhase 2 low-dose group CPhase 2 low-dose group D
high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)BIOLOGICAL

Intramuscular injection of high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm

Phase 1 high-dose groupPhase 2 high-dose group APhase 2 high-dose group BPhase 2 high-dose group CPhase 2 high-dose group D

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age range: healthy people aged 3 years and and older who can provide legal identification;
  • The subject and/or his legal guardian and/or his entrusted person can understand the study procedures and informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of the clinical study protocol;
  • Inquired about medical history and physical examination, the investigator judged that the health condition is good;
  • No history of SARS-CoV-2 vaccination before enrollment;
  • Females of childbearing age (menarche to menopause) are not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan within 12 months after enrollment; effective contraception will be taken within 2 weeks before enrollment;
  • During the entire study follow-up period, be able and willing to complete the entire prescribed study plan.

You may not qualify if:

  • Confirmed cases of SARS-CoV-2 infection, suspected cases, asymptomatic infections, or close contacts with the above population (check "China Disease Prevention and Control Information System");
  • Axillary body temperature is not less than 37.3℃ (older than 14 years) before vaccination, and axillary body temperature is not less than 37.5℃ (14 years or younger) before vaccination;
  • Positive in SARS-CoV-2 IgG and IgM antibody screening;
  • Have a history of SARS virus infection (self-report, on-site inquiry);
  • Fever (axillary temperature is not less than 37.3℃), dry cough, fatigue, nasal, congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, or dyspnea within 14 days before vaccination;
  • Before vaccination, the results of blood biochemistry, blood routine, urine routine, and coagulation function related indexes are abnormal, which exceed the reference value range, and have clinical significance abnormalities (only refers to phase I);
  • Previous severe allergic reaction to vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain);
  • Allergic to any component of the study vaccine (such as aluminum, histidine, etc.);
  • Have a history of convulsions, epilepsy, encephalopathy, long-term alcoholism and drug abuse, thyroidectomy, infectious diseases, mental illness or family history;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
  • Known or suspected diseases include: severe respiratory disease, severe liver and kidney disease, severe cardiovascular disease, drug-uncontrollable hypertension (systolic blood pressure is not less than 140mmHg, diastolic blood pressure is not less than 90mmHg), high blood glucose, diabetic complications , Malignant tumors, various acute diseases or acute attacks of chronic diseases;
  • Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
  • Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulopathy);
  • Asthenia or splenectomy, functional asthenia caused by any situation;
  • Are receiving anti-TB (tuberculosis) treatment;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ning ling Center for Disease Control and Prevention

Shangqiu, Henan, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

April 24, 2021

First Posted

May 3, 2021

Study Start

April 25, 2021

Primary Completion

August 29, 2023

Study Completion

August 29, 2023

Last Updated

January 16, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)