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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

Status unknown EARLY_PHASE1 Last updated 7 November 2022
What this trial tests

EARLY_PHASE1 trial testing V-01/V-01-B5 in COVID-19 Pandemic in 48 participants. Status unknown.

Timeline
16 September 2022
Primary endpoint
14 October 2022
11 September 2023

Quick facts

Lead sponsorLivzon Pharmaceutical Group Inc.
PhaseEARLY_PHASE1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeprevention
Enrollment48
Start date16 September 2022
Primary completion14 October 2022
Estimated completion11 September 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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

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Other recruiting trials for COVID-19 Pandemic

Currently open trials in the same condition.

Other Livzon Pharmaceutical Group Inc. trials

Trials by the same sponsor.

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Data sources for this page

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.

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