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A FIRST IN HUMAN TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF SARS-CoV-2 UQSC2 VACCINE IN HEALTHY ADULTS.

COVID-19 Clinical Trial

Official title:
A PHASE 1 RANDOMIZED, ACTIVE-CONTROLLED, DOUBLEBLIND, SINGLE CENTRE STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF AN ADJUVANTED SARS-CoV-2 UQSC2 PROTEIN SUBUNIT VACCINE IN HEALTHY ADULTS, AGED 18 TO 50 YEARS.

Clinical Trial Summary

This will be a single centre, Phase 1, First-In-Human , Randomized, Active-controlled (2- arm) Double-blind, single dose, parallel design study. The study will be conducted in a young healthy adult population aged ≥ 18 - ≤ 50 years. This study will consist of a single cohort of 70 subjects (35 receiving a single dose of UQSC2 vaccine and 35 subjects receiving a single dose of a TGA (Therapeutic Goods Administration) registered SARS-CoV-2 vaccine NVX-CoV2373).

Clinical Trial Description

Approximately 70 healthy adult males or non-pregnant females, ≥18 years - ≤ 50 years of age, non-smokers and social smokers (defined as the equivalent or fewer than 10 cigarettes per week), with BMI >18.0 and <34.0 kg/m2, will be recruited for participation in this study. All participants must have completed a primary SARS-CoV-2 vaccination series with one of two authorised mRNA SARS-CoV-2 vaccines (Pfizer/BioNTech or Moderna) and have received at least one booster dose of the Pfizer or Moderna SARS-CoV-2 vaccine at least 3 months prior to study entry, and will have not had a history of COVID-19 or virologically confirmed SARS-CoV-2 infection in the past 3 months, or will not have ongoing sequelae from a past COVID-19 infection. Subjects will be assigned to treatment group (UQSC2 or NVX-CoV2373) via randomisation. Each treatment group will receive a single dose of either UQSC2 or NVXCoV2373. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05775887
Study type Interventional
Source The University of Queensland
Contact
Status Completed
Phase Phase 1
Start date May 8, 2023
Completion date December 16, 2023
View Details
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