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

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).

Timeline

Start

2023-05-08

Primary completion

2023-12-02

Completion

2023-12-16

Publications

• Chappell KJ, Mordant FL, Amarilla AA, Modhiran N, Liang B, Li Z, Lackenby JA, Jaberolansar N, O'Donnell J, Kienzle V, Kommajosyula V, Tardiota N, Bennet JK, Henderson CL, Dalrymple RL, Goh J, Hoger K, Gillard M, Jones ML, Hughes K, Hughes B, Barnes J, Reading PC, Ranasinghe C, Subbarao K, Munro TP, Young PR, Watterson D. Safety and Immunogenicity of a Severe Acute Respiratory Syndrome Coronavirus 2 Spike Subunit Vaccine Stabilized in the Prefusion Conformation by a Second-Generation Molecular Clamp and Evaluated in Adults Aged 18-55 Years: A Randomized, Double-Blind, Active Comparator, Phase I Trial. J Infect Dis. 2026 Feb 18;233(2):e373-e382. doi: 10.1093/infdis/jiaf568.

Drugs

Indications