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Clinical trial

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

ID
Name
Vaxine-2301
Description
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.
Trial arms
Trial start
2024-04-21
Estimated PCD
2024-04-21
Trial end
2025-04-21
Status
Not yet recruiting
Phase
Early phase I
Treatment
Covid-19 vaccine
Recombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant
Arms:
Combined vaccine group, Covid-19 vaccine group, Influenza vaccine group
Other names:
SARS-CoV-2 vaccine
Influenza vaccine
Inactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant
Arms:
Combined vaccine group, Covid-19 vaccine group, Influenza vaccine group
Size
100
Primary endpoint
SARS-CoV-2 Seroconversion
Between baseline and 2 weeks post the second dose
Influenza Seroconversion
Between baseline and 2 weeks post the second dose
SARS-CoV-2 Seroprotection
Between baseline and 2 weeks post the second dose
Influenza Seroprotection
Between baseline and 2 weeks post the second dose
SARS-CoV-2 Geometric mean titer fold change
Between baseline and 2 weeks post the second dose
Influenza geometric mean titer fold change
Between baseline and 2 weeks post the second dose
Safety assessment 1
Between time of administration of first dose and through study completion, an average of 10 months
Safety assessment 2
Between time of administration of first dose and through study completion, an average of 10 months
SARS-CoV-2 infection
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Influenza infection
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Eligibility criteria
Inclusion Criteria: * Able to provide written informed consent * Males or females 18 years of age or older * Understand and are likely to comply with planned study procedures and be available for all study visits. * Do not plan to have a non-study COVID-19 or influenza vaccine within the next 6 months. Exclusion Criteria: * Allergy to COVID-19 or seasonal influenza vaccine or one of its components e.g. polysorbate 80. * Have received a COVID-19 or influenza vaccine or an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent or a COVID-19 or influenza vaccine during the trial reporting period. * Any serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomised, controlled cross-over study', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'A comparator vaccine (influenza) with an identical appearance will be used as the control.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-09

1 organization

2 products

3 indications

Organization
Vaxine
Product
Covid-19 vaccine
Indication
COVID-19 infection
Indication
Influenza
Indication
Human
Product
Influenza vaccine