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Covid-19 and Influenza Oral Vaccine Study

NCT06355232 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

  • covid19 Infection
  • Influenza, Human

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

Sponsors & Collaborators

  • Australian Respiratory and Sleep Medicine Institute Ltd

    collaborator UNKNOWN

  • Vaxine Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Dimitar Sajkov, MBBS/PhD · ARASMI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06355232 on ClinicalTrials.gov