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NCT04640402

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

Completed Phase 2 Last updated 1 June 2022
What this trial tests

Phase 2 trial testing Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen in COVID-19 in 960 participants. Completed in 23 November 2021.

Timeline
17 November 2020
Primary endpoint
18 February 2021
23 November 2021

Quick facts

Lead sponsorJiangsu Province Centers for Disease Control and Prevention
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment960
Start date17 November 2020
Primary completion18 February 2021
Estimated completion23 November 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jiangsu Province Centers for Disease Control and Prevention — full company profile →

Who can join

Adults 18 to 85, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. COVID-19 vaccines: rapid development, implications, challenges and future prospects.
    Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4
  2. Efficacy and safety of COVID-19 vaccines.
    Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
  3. Antibodies and Vaccines Target RBD of SARS-CoV-2.
    Min L, Sun Q. · · 2021 · cited 123× · PMID 33968996 · DOI 10.3389/fmolb.2021.671633
  4. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
    Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406
  5. Safety and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 years or older: two single-center, randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials.
    Meng FY, Gao F, Jia SY, Wu XH, et al · · 2021 · cited 26× · PMID 34267185 · DOI 10.1038/s41392-021-00692-3
  6. Pharmacological strategies to prevent SARS-CoV-2 infection and treat the early phases of COVID-19.
    Scarabel L, Guardascione M, Dal Bo M, Toffoli G. · · 2021 · cited 12× · PMID 33476760 · DOI 10.1016/j.ijid.2021.01.035
  7. A comprehensive overview of vaccines developed for pandemic viral pathogens over the past two decades including those in clinical trials for the current novel SARS-CoV-2.
    Damodharan K, Arumugam GS, Ganesan S, Doble M, et al · · 2021 · cited 7× · PMID 35479882 · DOI 10.1039/d0ra09668g
  8. Clinical progress of therapeutics and vaccines: Rising hope against COVID-19 treatment.
    Bandaru R, Rout SR, Kamble OS, Samal SK, et al · · 2022 · cited 4× · PMID 35437418 · DOI 10.1016/j.procbio.2022.04.011

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other Jiangsu Province Centers for Disease Control and Prevention trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04640402.

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