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

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

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) with immunization procedures 0, 21, 42 days and doses 40μg.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: Biological: Recombinant COVID-19 vaccine (Sf9 cells); Biological: Placebo

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: adults group (aged 18-59 years) & vaccine; three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42.	Biological: Recombinant COVID-19 vaccine (Sf9 cells); Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42.
Placebo Comparator: adults group (aged 18-59 years) & placebo; three doses of placebo at the schedule of day 0, 21, 42.	Biological: Placebo; Three doses of Placebo (1.0ml) at the schedule of day 0, 21, 42.
Experimental: elderly adults group (aged 60-85 years) & vaccine; three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42.	Biological: Recombinant COVID-19 vaccine (Sf9 cells); Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42.
Placebo Comparator: elderly adults group (aged 60-85 years) & placebo; three doses of placebo at the schedule of day 0, 21, 42.	Biological: Placebo; Three doses of Placebo (1.0ml) at the schedule of day 0, 21, 42.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse reaction (AR)	The incidence of adverse reaction (AR)	0 to 7 days after each dose
The incidence of Adverse Events of Special Interest (AESI)	The incidence of Adverse Events of Special Interest (AESI)	from day 0 to day 60 after last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse events (AE)	The incidence of adverse events (AE)	from day 0 to day 30 after last dose
The incidence of grade 3 adverse events (AE)	The incidence of grade 3 adverse events (AE)	from day 0 to day 30 after last dose
The incidence of severe adverse events (SAE)	The incidence of severe adverse events (SAE)	Month 12 after the whole process of vaccination
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.	day 30, day 60, month 6, month 12 after last dose
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)	day 30, day 60, month 6, month 12 after last dose
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	day 30, day 60, month 6, month 12 after last dose
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	day 30, day 60, month 6, month 12 after last dose
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)	day 30, day 60, month 6, month 12 after last dose
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)	day 30, day 60, month 6, month 12 after last dose

Collaborators and Investigators

• Sponsor: Jiangsu Province Centers for Disease Control and Prevention
• Collaborators: West China Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): May 15, 2021
• Study Completion (Anticipated): March 15, 2022

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; Recombinant vaccine; COVID-19 Vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: JSVCT107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No