NCT05465785

Brief Summary

This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 24, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

February 13, 2022

Last Update Submit

April 23, 2024

Conditions

COVID-19SARS-CoV-2 Pneumonia

Outcome Measures

Primary Outcomes (2)

  • The incidence of adverse reactions(ARs).

    The incidence of ARs within 7 days after each vaccination.

    Day 0 to day 7

  • Anti-SARS-CoV-2 specific neutralizing antibodies expressed as geometric mean titer (GMT)and seroconversion rate (SCR).

    The GMT and SCR of anti-SARS-CoV-2 specific neutralizing antibodies (euvirus) of the subjects on day 30 after the third vaccination.

    Day 72

Secondary Outcomes (5)

  • The incidence of ARs.

    Day 0 to Day 72

  • The incidence of adverse events (AEs).

    Day 0 to Day 72

  • The incidence of serious adverse events (SAEs).

    Day 0 to 6 months after the third vaccination.

  • The Geometric Mean Fold Increase (GMI) of the anti-SARS-COV-2 specific neutralizing antibody.

    Day 72

  • The Geometric Mean Titre (GMT), Seroconversion Rate (SCR) and GMI of anti-SARS-COV-2 S-RBD Immunoglobulin (IgG) antibody

    Day 72

Study Arms (2)

Pilot batch

EXPERIMENTAL

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

Biological: Recombinant COVID-19 vaccine (Sf9 cell)

Commercial batch

ACTIVE COMPARATOR

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

Biological: Recombinant COVID-19 vaccine (Sf9 cell)

Interventions

Recombinant COVID-19 vaccine (Sf9 cell)BIOLOGICAL

This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified

Commercial batchPilot batch

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects aged from 18-59 years.
  • Signed informed consent forms of the subjects have been obtained.
  • Able and willing to comply with the requirements of the clinical trial protocol and able to complete approximately 8 months of study follow-up.
  • Axillary temperature \< 37.3℃. Subjects who fulfill all the required conditions for receiving the candidate vaccine as established by medical history and physical examination and determined by investigators.

You may not qualify if:

  • Positive SARS-CoV-2 antibodies (IgG or IgM) screening results.
  • Positive SARS-CoV-2 Antigen screening results.
  • History of COVID-19 vaccination.
  • Previously diagnosed with COVID-19 infection.
  • History of HIV infection.
  • History or family history of convulsion, epilepsy, encephalopathy and psychosis.
  • Allergy to any component of the candidate vaccine, severe allergy to vaccine in the past, and history of allergy.
  • Women with positive urine pregnancy test results, pregnant, lactating women, or women who have a pregnancy plan during the study.
  • Patients with acute febrile diseases and infectious diseases.
  • Patients with a history of SARS.
  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by drugs, etc.
  • Serious chronic diseases or progressive stage of a disease that cannot be steadily controlled, such as asthma, diabetes mellitus, thyroid disease, etc.
  • Congenital or acquired angioedema/angioneurotic edema.
  • Urticaria 1 year before receiving the candidate vaccine.
  • Asplenia or functional asplenia.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Huai'an, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2022

First Posted

July 20, 2022

Study Start

July 20, 2022

Primary Completion

March 11, 2023

Study Completion

December 30, 2023

Last Updated

April 24, 2024

Record last verified: 2024-03

Locations

CN(1)