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UNKNOWNPHASE2

Immunogenicity and Safety of Recombinant COVID-19 Vaccine (CHO Cells)

A Single-center, Randomized, Double Blinded, Placebo Controlled, Phase 2 Clinical Trial of Recombinant COVID-19 Vaccine (CHO Cells), in the Subjects From Healthy Aged 18 Years and Above

NCT04813562•Jiangsu Province Centers for Disease Control and Prevention

View on ClinicalTrials.gov

Summary

This is a phase Ⅱ, randomized, placebo-controlled, double-blind study, to evaluate immunogenicity and safety of a recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with an immunization procedure (0, 28, 56 days).

Detailed Description

This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 4 research group, including an immunization procedures (0, 28, 56 days), two doses (20μg/0.5ml, 40μg/0.5ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 480 in total. Cellular immune blood samples were collected from the top 96 subjects (i.e., the top 24 in each study group, vaccine group: control group =5:1), and Elispot test and cytokine staining (ICS)/flow assay were performed.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy subjects of ≥ 18 years old.
•The subject can understand and voluntarily sign the informed consent.
•Axillary temperature ≤37.0℃.
•General good health as established by medical history and physical examination

Exclusion Criteria

•Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomatic infection in the previous 14 days, or a travel history/residential history in a community where a case has been reported.
•Have a history of contact with a person infected with SARS-CoV-2(a person with a positive nucleic acid test) in the previous 14 days.
•Patients with fever or respiratory symptoms who have been to middle or high-risk areas in the past 14 days or have exit history, or come from communities with case reports.
•In the past 14 days, there have been 2 or more cases of fever and/or respiratory symptoms in small areas such as homes, offices, school classes, etc.
•Have a history of SARS.
•Have a history of SARS-CoV-2 infection or history of Coronavirus Vaccination (including Emergency Vaccine and Experimental Vaccine).
•Positive in SARS-CoV-2 IgG or IgM antibody screening.
•Have a history of HIV infection;
•Women who are breastfeeding, pregnant, or planning to become pregnant during 6 months after full-course vaccination (based on the subject's self-report and blood pregnancy test results for women of childbearing age).
•Have a history of asthma, a history of vaccine or vaccine component allergy, have serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema.
+19 more criteria

Locations (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Key Dates

Start Date

March 23, 2021

Primary Completion Date

July 30, 2022

Completion Date

July 30, 2022

Last Updated

March 31, 2022

Enrollment

480

ESTIMATED participants

Conditions

COVID-19

Interventions

a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56

BIOLOGICAL

a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56

BIOLOGICAL

a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56

BIOLOGICAL

a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56

BIOLOGICAL

a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56

BIOLOGICAL

a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56

BIOLOGICAL

a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56

BIOLOGICAL

a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56

BIOLOGICAL

Contacts

Fanyue Meng, Doctor

CONTACT

18915999245 mfy19780712@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 31, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunogenicity and Safety of Recombinant COVID-19 Vaccine (CHO Cells)

Inclusion Criteria

Exclusion Criteria

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