NCT05775887

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: The University of Queensland · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	UQSC2 Vaccine	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 NVX-CoV2373. The Study will be unblinded after Day 29, to enable subjects who received the investigational vaccine (UQSC2 vaccine) to seek vaccination with a TGA (Therapeutic Goods Administration) approved COVID-19 booster vaccine if indicated by public health authorities.
BIOLOGICAL	NVX-CoV2373 vaccine	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 NVX-CoV2373

Timeline

• Start date: 2023-05-08
• Primary completion: 2023-12-02
• Completion: 2023-12-16
• First posted: 2023-03-20
• Last updated: 2024-03-06

Locations

1 site across 1 country: Australia