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

NCT04718467 | Withdrawn Phase 2 DMC

• 1 other identifier: JSVCT107
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Safety; Immunogenicity; COVID-19 Vaccine; Recombinant vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• The incidence of adverse events (AE)

  from day 0 to day 30 after last dose

• The incidence of grade 3 adverse events (AE)

  from day 0 to day 30 after last dose

• The incidence of severe adverse events (SAE)

  Month 12 after the whole process of vaccination

• Geometric mean (GMT) of specific antibody

  day 30, day 60, month 6, month 12 after last dose

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

  day 30, day 60, month 6, month 12 after last dose

Study Arms (4)

adults group (aged 18-59 years) & vaccine

EXPERIMENTAL

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)

adults group (aged 18-59 years) & placebo

PLACEBO COMPARATOR

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

Biological: Placebo

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

EXPERIMENTAL

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)

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

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Recombinant COVID-19 vaccine (Sf9 cells) 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) & vaccine; elderly adults group (aged 60-85 years) & vaccine

Placebo BIOLOGICAL

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

adults group (aged 18-59 years) & placebo; elderly adults group (aged 60-85 years) & placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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℃

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• West China Hospital: collaborator

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fengcai Zhu, Doctor

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: February 1, 2021
• Primary Completion: May 15, 2021
• Study Completion: March 15, 2022
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

CN (1)