Who is sponsoring NCT05398848?

NCT05398848 is sponsored by Jiangsu Rec-Biotechnology Co., Ltd..

What drugs are being tested in NCT05398848?

Interventions in NCT05398848: Recombinant two-component COVID-19 vaccine (CHO cell), Placebo.

Is NCT05398848 still recruiting?

NCT05398848 is currently completed. Last updated 29 February 2024.

Last reviewed 2024-02-29 · How we verify

NCT05398848

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

Efficacy, Safety and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell)(Recov)

Completed Phase 3 Last updated 29 February 2024

What this trial tests

Phase 3 trial testing Recombinant two-component COVID-19 vaccine (CHO cell) in COVID-19 in 7,623 participants. Completed in 29 December 2023.

Timeline

31 October 2022

Primary endpoint
4 September 2023

29 December 2023

Quick facts

Lead sponsor	Jiangsu Rec-Biotechnology Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	7,623
Start date	31 October 2022
Primary completion	4 September 2023
Estimated completion	29 December 2023
Sites	11 locations across Russia, Nepal

Drugs / interventions tested

Recombinant two-component COVID-19 vaccine (CHO cell) — full drug profile →
Placebo

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

Jiangsu Rec-Biotechnology Co., Ltd. — full company profile →

Who can join

Adults 18 to 80, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter designed Phase III clinical trial. About 10000 participants plan to be enrolled.The objectives of this study are to evaluate the efficacy, safety and immunogenicity of the recombinant two-component COVID-19 vaccine (CHO cell) in adults

Publications & conference data

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

An overview on nanoparticle-based strategies to fight viral infections with a focus on COVID-19.
Yasamineh S, Kalajahi HG, Yasamineh P, Yazdani Y, et al · · 2022 · cited 53× · PMID 36209089 · DOI 10.1186/s12951-022-01625-0
Vaccine adjuvants for infectious disease in the clinic.
Goetz M, Thotathil N, Zhao Z, Mitragotri S. · · 2024 · cited 29× · PMID 39036089 · DOI 10.1002/btm2.10663
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
Safety and Immunogenicity of a Recombinant Two-Component SARS-CoV-2 Protein Vaccine: Randomized, Double-Blind, Placebo-Controlled Phase I and Phase II Studies.
Wynne C, Balgos A, Li J, Hamilton P, et al · · 2024 · cited 1× · PMID 38103161 · DOI 10.1007/s40121-023-00896-w

Verify or expand the search:

Other trials of Recombinant two-component COVID-19 vaccine (CHO cell)

Trials testing the same drug.

NCT05323435 — Immunogenicity and Safety Study of Recombinant Two-Component COVID-19 Vaccine (CHO Cell)(ReCOV) · Phase 2 · completed
NCT04818801 — Safety, Reactogenicity and Immunogenicity Study of ReCOV · EARLY_PHASE1 · completed

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 Jiangsu Rec-Biotechnology Co., Ltd. trials

Trials by the same sponsor.

NCT05769049 — The Safety and Immunogenicity Study of the Recombinant Zoster Vaccine (CHO Cell) · Phase 1 · completed
NCT05323435 — Immunogenicity and Safety Study of Recombinant Two-Component COVID-19 Vaccine (CHO Cell)(ReCOV) · Phase 2 · completed
NCT05084989 — Safety, and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) · Phase 2 · completed
NCT04818801 — Safety, Reactogenicity and Immunogenicity Study of ReCOV · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05398848 (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 Rec-Biotechnology Co., Ltd.
Last refreshed: 29 February 2024

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/NCT05398848.

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