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RECRUITING
NCT06355232
PHASE1

Covid-19 and Influenza Oral Vaccine Study

Sponsor: Vaxine Pty Ltd

View on ClinicalTrials.gov

Summary

The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral/ sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines.

Official title: A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-05-01

Completion Date

2026-12-31

Last Updated

2025-09-17

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Covid-19 vaccine

Recombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant

BIOLOGICAL

Influenza vaccine

Inactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant

Locations (1)

ARASMI

Adelaide, South Australia, Australia