Actively Recruiting
A Randomized, Triple-Blind, Controlled Cross-Over Trial to Assess Safety and Efficacy of Oral Mucosal COVID-19 and Influenza Vaccines
Led by Vaxine Pty Ltd · Updated on 2025-09-17
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
Vaxine Pty Ltd
Lead Sponsor
A
Australian Respiratory and Sleep Medicine Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of protein-based COVID-19 and influenza vaccines administered via the oral or sublingual mucosal route compared to traditional intramuscular delivery. This study aims to improve mucosal immunity, which may better prevent infection and transmission at the body's respiratory surfaces. It uses a cross-over design where participants receive both vaccines over about four months. Participants will be randomly assigned to one of three groups: one receiving two sublingual doses of COVID-19 vaccine followed by two influenza doses three months later; another receiving influenza vaccine doses followed by COVID-19 doses; and a third group receiving combined COVID-19 and influenza vaccines followed by placebo doses. All vaccines use Advax-CpG adjuvant and are given two weeks apart in two doses. During the study, participants will attend multiple visits for vaccine administration and monitoring. Researchers will assess immune responses by measuring antibody levels and seroconversion two weeks after vaccination. Safety will be monitored throughout an average 10-month period, along with tracking COVID-19 and influenza infections. Antibody durability and correlates of protection will also be evaluated during follow-up.
CONDITIONS
Brief Title
Covid-19 and Influenza Oral Vaccine Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Male or female aged 18 years or older
- Willing and likely to follow study procedures and attend all visits
- Do not plan to receive non-study COVID-19 or influenza vaccines within 6 months
You will not qualify if you...
- Allergy to COVID-19 or seasonal influenza vaccine or any components such as polysorbate 80
- Received a COVID-19, influenza vaccine, or experimental agent within 30 days before study vaccination or expect to receive any during the trial
- Any serious medical, social, or mental condition that may harm the participant or affect the study according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 months
Participants receive two sublingual doses of either COVID-19 vaccine, influenza vaccine, or combined COVID-19 and influenza vaccine two weeks apart, followed by a crossover to the alternate vaccine or placebo after three months.
2 dosing visits two weeks apart, then 2 dosing visits two weeks apart after 3 months
Duration - Approximately 10 months
Participants are monitored for safety, immune response, and infection outcomes for an average of 10 months after the second dose in each treatment period.
Regular visits for safety and antibody assessments during follow-up
Trial Site Locations
Total: 1 location
1
ARASMI
Adelaide, South Australia, Australia, 5042
Actively Recruiting
Research Team
S
Sharen Pringle, GradCert
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
3
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