A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)

May 31, 2022 updated by: Jiangsu Province Centers for Disease Control and Prevention

A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above

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 (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 (Sf9 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 8 research group, including two immunization procedures (0, 21 days and 0, 14, 28 days), two doses (20μg/0.5ml, 40μg/1.0ml) 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, 960 in total.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
960

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Provincial Center for Diseases Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 years and above.
  • Able to understand the content of informed consent and willing to sign the informed consent.
  • Able and willing to complete all the secluded study process during the whole study follow-up period (about 7 months).
  • Axillary temperature ≤37.0℃.
  • General good health as established by medical history and physical examination.

Exclusion Criteria:

First dose exclusion criteria:

  • Positive serum immunoglobulin M (IgM) and IgG to the SARS-CoV-2.
  • A Known History of HIV infection
  • Family history of seizure, epilepsy, brain or mental disease.
  • Participant that has an allergic history to any ingredient of vaccines.
  • Woman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months.
  • Any acute fever disease or infections.
  • Have a medical history of SARS.
  • Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled.
  • Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled.
  • Hereditary angioneurotic edema or acquired angioneurotic edema.
  • Urticaria in last one year.
  • Asplenia or functional asplenia.
  • Platelet disorder or other bleeding disorder may cause injection contraindication.
  • Faint at the sight of blood or needles.
  • Prior administration of immunodepressant or corticosteroids, antianaphylactics treatment, cytotoxic treatment in last 6 months.
  • Prior administration of blood products in last 4 months.
  • Prior administration of other research medicines in last 1 month.
  • Prior administration of attenuated vaccine in last 1 month.
  • Prior administration of subunit vaccine or inactivated vaccine in last 14 days.
  • Being treated for tuberculosis.
  • Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives.

Exclusion criteria for subsequent doses:

  • Patients with severe allergic reactions after the previous dose of vaccination;
  • Patients with serious adverse events causally related to the previous dose of vaccination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-dose vaccine (18-59 years) & Two dose regimen
two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Experimental: Low-dose vaccine (18-59 years) & Three dose regimen
three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Experimental: High-dose vaccine (18-59 years) & Two dose regimen
two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Experimental: High-dose vaccine (18-59 years) & Three dose regimen
three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Experimental: Low-dose vaccine (60-85 years) & Two dose regimen
two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Experimental: Low-dose vaccine (60-85 years) & Three dose regimen
three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Experimental: High-dose vaccine (60-85 years) & Two dose regimen
two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Experimental: High-dose vaccine (60-85 years) & Three dose regimen
three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Placebo Comparator: Low-dose placebo (18-59 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
Biological: Low-dose placebo (18-59 years) & Two dose regimen
18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
Placebo Comparator: Low-dose placebo (18-59 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
Biological: Low-dose placebo (18-59 years) & Three dose regimen
18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
Placebo Comparator: High-dose placebo (18-59 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
Biological: High-dose placebo (18-59 years) & Two dose regimen
18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
Placebo Comparator: High-dose placebo (18-59 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
Biological: High-dose placebo (18-59 years) & Three dose regimen
18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
Placebo Comparator: Low-dose placebo (60-85 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
Biological: Low-dose placebo (60-85 years) & Two dose regimen
60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
Placebo Comparator: Low-dose placebo (60-85 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
Biological: Low-dose placebo (60-85 years) & Three dose regimen
60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
Placebo Comparator: High-dose placebo (60-85 years) & Two dose regimen
two doses of placebo at the schedule of day 0, 21.
Biological: High-dose placebo (60-85 years) & Two dose regimen
60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
Placebo Comparator: High-dose placebo (60-85 years) & Three dose regimen
three doses of placebo at the schedule of day 0, 14, 28.
Biological: High-dose placebo (60-85 years) & Three dose regimen
60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric mean (GMT) of specific antibody
Time Frame: 1 months after immunization in each study group
Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA)
1 months after immunization in each study group
The incidence of adverse reaction (AR)
Time Frame: 0 to 7 days after vaccination in each study group
The incidence of adverse reaction (AR)
0 to 7 days after vaccination in each study group

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of adverse events (AE)
Time Frame: 0 to 28 days after vaccination in each study group
The incidence of adverse events (AE)
0 to 28 days after vaccination in each study group
The incidence of severe adverse events (SAE)
Time Frame: 0 to 28 days after vaccination in each study group
The incidence of severe adverse events (SAE)
0 to 28 days after vaccination in each study group
The incidence of serious adverse events
Time Frame: 6 months after vaccination in each study group
The incidence of serious adverse events
6 months after vaccination in each study group
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies
Time Frame: 1 months after immunization in each study group
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)
1 months after immunization in each study group
The positive conversion rate of S-RBD protein-specific antibody
Time Frame: 14 days, 30 days after immunization in each study group
The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2
14 days, 30 days after immunization in each study group
Geometric mean fold increase (GMI) of S-RBD protein-specific antibody
Time Frame: 14 days, 30 days after immunization in each study group
Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2
14 days, 30 days after immunization in each study group
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies
Time Frame: 14 days after immunization in each study group
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)
14 days after immunization in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody
Time Frame: 14 days, 30 days after immunization in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test)
14 days, 30 days after immunization in each study group
Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies
Time Frame: 14 days, 30 days after immunization in each study group
Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays)
14 days, 30 days after immunization in each study group

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The consistency analysis of the specific antibody and the specific neutralizing antibody
Time Frame: 1 months after immunization in each study group
The consistency analysis of the specific antibody (ELISA) and the specific neutralizing antibody (euvirus and pseudovirus neutralization assays) against SARS-CoV-2 S-RBD protein
1 months after immunization in each study group
The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
Time Frame: 1 months after immunization in each study group
The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups
1 months after immunization in each study group
The persistence (GMT，GMI，positive conversion rate) of specific antibodies
Time Frame: 6 months after vaccination in each study group
The persistence (GMT，GMI，positive conversion rate) of specific antibodies against SARS-CoV-2 S-RBD protein
6 months after vaccination in each study group
Subtypes of immunoglobulin G (IgG) antibodies
Time Frame: 1 months after immunization in each study group
Subtypes of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group
1 months after immunization in each study group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 18, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JSVCT099

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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