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Phase IIb Clinical Trial of Recombinant Novel Coronavirus Pneumonia (COVID-19) Vaccine (Sf9 Cells)

Primary Purpose

COVID-19

Status

Withdrawn

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Recombinant COVID-19 vaccine (Sf9 cells)

Placebo

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged 18-85 years old
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 14 months).
Axillary temperature ≤37.0℃

Exclusion Criteria:

Positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS-CoV-2.
SARS-CoV-2 nucleic acid testing positive.
History of SARS-CoV-2 infection or vaccination
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 14 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.
Malignant tumor, activity or have been treated tumor and no clear have cured, or during the study period is likely to relapse.
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.
Nearly 7 days, all sorts of acute onset of disease or chronic diseases, such as receiving anti-tuberculosis treatment, history of asthma.
According to the investigator's judgment, due to various medical, psychological, social or other conditions, it is contrary to the trial protocol or affects the subjects to sign informed consent.

Exclusion criteria for subsequent doses:

Appear systemic allergic reaction, severe allergic reactions.
Appear difficult to tolerate more than grade 3 adverse reactions.
New discovery or a new happened after the first vaccination does not conform to the first dose of the inclusion criteria or conform to the first dose of exclusion criteria, determine whether or not to continue to participate in the study by the investigators.
Investigators think of other reasons.

Sites / Locations

Jiangsu Provincial Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

adults group (aged 18-59 years) & vaccine

adults group (aged 18-59 years) & placebo

elderly adults group (aged 60-85 years) & vaccine

elderly adults group (aged 60-85 years) & placebo

Arm Description

three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42.

three doses of placebo at the schedule of day 0, 21, 42.

three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42.

three doses of placebo at the schedule of day 0, 21, 42.

Outcomes

Primary Outcome Measures

The incidence of adverse reaction (AR)

The incidence of Adverse Events of Special Interest (AESI)

Secondary Outcome Measures

The incidence of adverse events (AE)

The incidence of grade 3 adverse events (AE)

The incidence of severe adverse events (SAE)

Geometric mean (GMT) of specific antibody

Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA) in immunogenicity subgroup.

Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies

Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)

The positive conversion rate of S-RBD protein-specific antibody

The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2

Geometric mean fold increase (GMI) of S-RBD protein-specific antibody

Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2

The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody

The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test)

Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies

Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays)

Full Information

NCT ID

NCT04718467

First Posted

January 20, 2021

Last Updated

May 21, 2021

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

West China Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04718467

Brief Title

Phase IIb Clinical Trial of Recombinant Novel Coronavirus Pneumonia (COVID-19) Vaccine (Sf9 Cells)

Official Title

A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 to 85 Years Old

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor decided to cancel this trial.

Study Start Date

February 1, 2021 (Anticipated)

Primary Completion Date

May 15, 2021 (Anticipated)

Study Completion Date

March 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Detailed Description

This is a phase Ⅱb, 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 18-59 and 60-85 years) . The phase Ⅱb clinical trials designed two research group, including adults group (aged 18-59 years) and elderly adults group (aged 60-85 years). Each group including 2000 participants. Vaccination or placebo group will be randomly assigned to receive in a 3:1 ratio, 4000 in total.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

adults group (aged 18-59 years) & vaccine

Arm Type

Experimental

Arm Description

three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42.

Arm Title

adults group (aged 18-59 years) & placebo

Arm Type

Placebo Comparator

Arm Description

three doses of placebo at the schedule of day 0, 21, 42.

Arm Title

elderly adults group (aged 60-85 years) & vaccine

Arm Type

Experimental

Arm Description

three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42.

Arm Title

elderly adults group (aged 60-85 years) & placebo

Arm Type

Placebo Comparator

Arm Description

three doses of placebo at the schedule of day 0, 21, 42.

Intervention Type

Biological

Intervention Name(s)

Recombinant COVID-19 vaccine (Sf9 cells)

Intervention Description

Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Three doses of Placebo (1.0ml) at the schedule of day 0, 21, 42.

Primary Outcome Measure Information:

Title

The incidence of adverse reaction (AR)

Description

The incidence of adverse reaction (AR)

Time Frame

0 to 7 days after each dose

Title

The incidence of Adverse Events of Special Interest (AESI)

Description

The incidence of Adverse Events of Special Interest (AESI)

Time Frame

from day 0 to day 60 after last dose

Secondary Outcome Measure Information:

Title

The incidence of adverse events (AE)

Description

The incidence of adverse events (AE)

Time Frame

from day 0 to day 30 after last dose

Title

The incidence of grade 3 adverse events (AE)

Description

The incidence of grade 3 adverse events (AE)

Time Frame

from day 0 to day 30 after last dose

Title

The incidence of severe adverse events (SAE)

Description

The incidence of severe adverse events (SAE)

Time Frame

Month 12 after the whole process of vaccination

Title

Geometric mean (GMT) of specific antibody

Description

Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA) in immunogenicity subgroup.

Time Frame