Who is sponsoring NCT05616754?

NCT05616754 is sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..

What drugs are being tested in NCT05616754?

Interventions in NCT05616754: Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells), Recombinant Novel Coronavirus Protein Vaccine (CHO cells).

Is NCT05616754 still recruiting?

NCT05616754 is currently status unknown. Last updated 15 November 2022.

Last reviewed 2022-11-15 · How we verify

NCT05616754

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

A Trial Evaluate the Immunogenicity and Safety of Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell)

Status unknown Phase 3 Last updated 15 November 2022

What this trial tests

Phase 3 trial testing Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells) in COVID-19 in 400 participants. Status unknown.

Timeline

7 November 2022

Primary endpoint
30 July 2023

30 September 2023

Quick facts

Lead sponsor	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	400
Start date	7 November 2022
Primary completion	30 July 2023
Estimated completion	30 September 2023
Sites	1 location across Uzbekistan

Drugs / interventions tested

Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells) — full drug profile →
Recombinant Novel Coronavirus Protein Vaccine (CHO cells) — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

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

Who can join

Eligibility, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study was designed as a randomized, blind and controlled trial. A total of 300 patients aged 18 and above who were immunized with recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months (60 patients aged 60 and above) were randomly and blind divided into the experimental group and the control group, and received the experimental vaccine and the control vaccine, respectively. In addition, 100 patients over 4 months after the completion of basic immunization with COVID-19 mRNA vaccine were selected as the open observation group, all of whom received 1 dose of experimental vaccine.

Publications & conference data

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

Neutralization of BQ.1, BQ.1.1, and XBB with RBD-Dimer Vaccines.
Li D, Duan M, Wang X, Gao P, et al · · 2023 · cited 28× · PMID 36856580 · DOI 10.1056/nejmc2216233
A booster of Delta-Omicron RBD-dimer protein subunit vaccine augments sera neutralization of Omicron sub-variants BA.1/BA.2/BA.2.12.1/BA.4/BA.5.
Duan M, Duan H, An Y, Zheng T, et al · · 2023 · cited 6× · PMID 36803449 · DOI 10.1080/22221751.2023.2179357

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
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 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 NCT05616754 (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: 15 November 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/NCT05616754.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing