Who is sponsoring NCT05128643?

NCT05128643 is sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..

What drugs are being tested in NCT05128643?

Interventions in NCT05128643: Recombinant novel coronavirus vaccine (CHO cell).

What condition does NCT05128643 study?

NCT05128643 studies Coronavirus Disease 2019.

Is NCT05128643 still recruiting?

NCT05128643 is currently status unknown. Last updated 22 February 2022.

Last reviewed 2022-02-22 · How we verify

NCT05128643

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Study on the Immune Program of Recombinant Novel Coronavirus（COVID-19) Vaccine (CHO Cell)

Status unknown Phase 3 Last updated 22 February 2022

What this trial tests

Phase 3 trial testing Recombinant novel coronavirus vaccine (CHO cell) in Coronavirus Disease 2019 in 300 participants. Status unknown.

Timeline

17 September 2021

Primary endpoint
12 April 2022

12 October 2022

Quick facts

Lead sponsor	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	300
Start date	17 September 2021
Primary completion	12 April 2022
Estimated completion	12 October 2022
Sites	1 location across China

Drugs / interventions tested

Recombinant novel coronavirus vaccine (CHO cell) — full drug profile →

Conditions studied

Coronavirus Disease 2019 — all drugs for Coronavirus Disease 2019 →

Sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Coronavirus Disease 2019. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Popular topic：Clinical study on the immune program of recombinant Novel Coronavirus (COVID-19) vaccine (CHO cell). Research purpose:Main purpose: To evaluate the immunogenicity of recombinant novel coronavirus vaccine (CHO cells) inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and over. Secondary purpose: To evaluate the safety of the investigational vaccine in people aged 18 and above. Overall design: In this study, recombinant novel coronavirus vaccine (CHO cells) is inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and older to evaluate the immunogenicity and safety. Study population:The study involved people 18 years of age and older. Test groups：A total of 300 subjects were enrolled, including 221 in the 18-59 age group and 79 in the ≥60 age group. Three doses of experimental vaccine were administered according to the 0,1,6 month immunization schedule (Study No. 001-150) or 0,1,4 months immunization schedule (Study No. 151-300).

Publications & conference data

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

Nanoparticles in clinical trials of COVID-19: An update.
Rauf A, Abu-Izneid T, Khalil AA, Hafeez N, et al · · 2022 · cited 22× · PMID 35953020 · DOI 10.1016/j.ijsu.2022.106818
Recombinant Protein Vaccines against Human Betacoronaviruses: Strategies, Approaches and Progress.
Kovalenko A, Ryabchevskaya E, Evtushenko E, Nikitin N, et al · · 2023 · cited 15× · PMID 36675218 · DOI 10.3390/ijms24021701
Understanding the challenges to COVID-19 vaccines and treatment options, herd immunity and probability of reinfection.
Al-Hatamleh MAI, Abusalah MA, Hatmal MM, Alshaer W, et al · · 2023 · cited 7× · PMID 36570799 · DOI 10.1016/j.jtumed.2022.11.007

Verify or expand the search:

Other recruiting trials for Coronavirus Disease 2019

Currently open trials in the same condition.

NCT05160636 — A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza · active not recruiting
NCT05164744 — Cardiac Magnetic Resonance Tissue Characterization in COVID-19 Survivors · recruiting

Other Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. trials

Trials by the same sponsor.

NCT06747455 — BCG for Therapeutic Use Phase Ⅲ Clinical Trial · Phase 3 · recruiting
NCT06524947 — Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris) · Phase 3 · active not recruiting
NCT06100653 — BCG for Therapeutic Use Phase I Clinical Trial · Phase 1 · completed
NCT06025812 — Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) · NA · unknown
NCT05899179 — Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05128643 (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 Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Last refreshed: 22 February 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/NCT05128643.

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