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NCT04640402
A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)
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.
18 February 2021
Quick facts
| Lead sponsor | Jiangsu Province Centers for Disease Control and Prevention |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 960 |
| Start date | 17 November 2020 |
| Primary completion | 18 February 2021 |
| Estimated completion | 23 November 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
- Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen — full drug profile →
- High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
- High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
- Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
- Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
- High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
- High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen — full drug profile →
- Low-dose placebo (18-59 years) & Two dose regimen
- Low-dose placebo (18-59 years) & Three dose regimen — full drug profile →
- High-dose placebo (18-59 years) & Two dose regimen
- High-dose placebo (18-59 years) & Three dose regimen
- Low-dose placebo (60-85 years) & Two dose regimen
- Low-dose placebo (60-85 years) & Three dose regimen — full drug profile →
- High-dose placebo (60-85 years) & Two dose regimen — full drug profile →
- High-dose placebo (60-85 years) & Three dose regimen
Conditions studied
- COVID-19 — all drugs for COVID-19 →
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):
-
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 -
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 -
Antibodies and Vaccines Target RBD of SARS-CoV-2.
Min L, Sun Q. · · 2021 · cited 123× · PMID 33968996 · DOI 10.3389/fmolb.2021.671633 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04640402
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other Jiangsu Province Centers for Disease Control and Prevention trials
Trials by the same sponsor.
- NCT07530679 — Study on the Safety, Humoral Immune Response, and Memory B Cell Response Characteristics of Sequential 9-Valent HPV Vacc · NA · not yet recruiting
- NCT07232745 — Mucosal and Systemic Immune Responses Induced by an Intranasal Influenza Live Attenuated Vaccine · Phase 4 · active not recruiting
- NCT06609811 — The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuat · Phase 4 · completed
- NCT07035054 — Phase Ⅱ Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine · Phase 2 · completed
- NCT07025876 — PhaseⅠClinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine · EARLY_PHASE1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04640402 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu Province Centers for Disease Control and Prevention
- Last refreshed: 1 June 2022
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing