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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640402
• Other study ID #: JSVCT099
• Status: Completed
• Phase: Phase 2
• Start date: November 17, 2020
• Est. completion date: November 23, 2021

Study information

• Verified date: March 2022
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 960
• Est. completion date: November 23, 2021
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Jiangsu Provincial Center for Diseases Control and Prevention	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The consistency analysis of the specific antibody and the specific neutralizing antibody	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
Other	The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody	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
Other	The persistence (GMT,GMI,positive conversion rate) of specific antibodies	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
Other	Subtypes of immunoglobulin G (IgG) antibodies	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
Primary	Geometric mean (GMT) of specific antibody	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
Primary	The incidence of adverse reaction (AR)	The incidence of adverse reaction (AR)	0 to 7 days after vaccination in each study group
Secondary	The incidence of adverse events (AE)	The incidence of adverse events (AE)	0 to 28 days after vaccination in each study group
Secondary	The incidence of severe adverse events (SAE)	The incidence of severe adverse events (SAE)	0 to 28 days after vaccination in each study group
Secondary	The incidence of serious adverse events	The incidence of serious adverse events	6 months after vaccination in each study group
Secondary	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)	1 months after immunization in each study group
Secondary	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	14 days, 30 days after immunization in each study group
Secondary	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	14 days, 30 days after immunization in each study group
Secondary	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)	14 days after immunization in each study group
Secondary	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)	14 days, 30 days after immunization in each study group
Secondary	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)	14 days, 30 days after immunization in each study group