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NCT05585567: COVID-19
A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5
EARLY_PHASE1 trial testing V-01/V-01-B5 in COVID-19 Pandemic in 48 participants. Status unknown.
14 October 2022
Quick facts
| Lead sponsor | Livzon Pharmaceutical Group Inc. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 48 |
| Start date | 16 September 2022 |
| Primary completion | 14 October 2022 |
| Estimated completion | 11 September 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- V-01/V-01-B5 — full drug profile →
- V-01-351/V-01-B5 — full drug profile →
- V-01 — full drug profile →
Conditions studied
- COVID-19 Pandemic — all drugs for COVID-19 Pandemic →
Sponsor
Livzon Pharmaceutical Group Inc. — full company profile →
Who can join
Adults 18 to 59, any sex, with COVID-19 Pandemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Bivalent COVID-19 Booster Immunization after Three Doses of Inactivated Vaccine Augments the Neutralizing Antibody Response against Circulating Omicron Sublineages.
He Q, Sun S, Chen X, Hu Z, et al · · 2022 · cited 9× · PMID 36614948 · DOI 10.3390/jcm12010146
Verify or expand the search:
- PubMed search for NCT05585567
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COVID-19 Pandemic
Currently open trials in the same condition.
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- NCT06927622 — Corona Virus Disease 2019 Cohort Study · recruiting
- NCT05096260 — Getting to Yes, Michigan! (G2YMI) · NA · active not recruiting
- NCT06208943 — Neural and Cognitive Consequences of COVID-19 Survival · recruiting
Other Livzon Pharmaceutical Group Inc. trials
Trials by the same sponsor.
- NCT06963320 — Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty · Phase 2 · recruiting
- NCT06850480 — A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis · Phase 3 · recruiting
- NCT05583357 — Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 · EARLY_PHASE1 · unknown
- NCT05273528 — The Immunogenicity and Safety of V-01-351/V-01D Bivalence Vaccine · Phase 2 · unknown
- NCT05238649 — Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine · Phase 2 · unknown
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 NCT05585567 (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 Livzon Pharmaceutical Group Inc.
- Last refreshed: 7 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/NCT05585567.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing