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

NCT ID: NCT04718467

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-03-15

Brief Summary

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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Recombinant COVID-19 vaccine (Sf9 cells)

Intervention Type: BIOLOGICAL

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

adults group (aged 18-59 years) & placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Recombinant COVID-19 vaccine (Sf9 cells)

Intervention Type: BIOLOGICAL

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

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Interventions

Recombinant COVID-19 vaccine (Sf9 cells)

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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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℃

• Investigators think of other reasons.

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.

• Appear systemic allergic reaction, severe allergic reactions.
• Appear difficult to tolerate more than grade 3 adverse reactions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengcai Zhu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Disease Control and Prevention

Locations

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

JSVCT107

Identifier Type: -

Identifier Source: org_study_id